IPI - Volume 18 Issue 1 - Spring 2026

Volume 18 Issue 1

Peer Reviewed

Advancing Life Sciences with Automation:

The Key to Faster, Safer and More Sustainable Drug Delivery

From Impossible to Circular:

Unlocking Recycling Pathways for Pharmaceutical Packaging

The Platform Effect:

Elevating Manufacturing Efficiency in Injectable Drug Delivery

Spray Pattern and Plume Geometry:

Regulatory Convergence and Technological Innovation in Inhaled and Nasal Drug Products

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Contents 04

Editor’s Letter

TALKING POINT 06

Preparing for Change: A Look- Forward at the New UK Clinical Trial Regulations with Olive McCormick, Almac Group

DIRECTOR: Mark A. Barker

Olive McCormick of Almac Group explains that new UK clinical trial regulations aim to speed approvals and simplify processes. Sponsors face challenges transitioning ongoing trials, especially in labelling, supply, and compliance, making clear understanding essential to ensure continuity and avoid risks.

BUSINESS DEVELOPMENT: Anthony Stewart anthony@senglobalcoms.com

REGULATORY & MARKETPLACE

MANAGING EDITOR: Alice Phillips alice@senglobalcoms.com EDITORIAL ASSISTANTS: Melissa Canver melissa@senglobalcoms.com Carla Devine carla@senglobalcoms.com DESIGN DIRECTOR: Jana Sukenikova www.fanahshapeless.com FINANCE DEPARTMENT: Akash Sharma accounts@senglobal.com COVER IMAGE: iStockphoto © PUBLISHED BY: Senglobal Ltd., 2 Larch Court, London United Kingdom, SE1 3GB Tel: +44 (0) 203 3420130 Email: info@senglobalcoms.com www.international-pharma.com All rights reserved. No part of this publication may be reproduced, duplicated, stored in any retrieval system or transmitted in any form by any means without prior written permission of the Publishers.

The next issue of IPI will be published in Summer 2026.

ISSN No.International Pharmaceutical Industry ISSN 1755-4578.

The opinions and views expressed by the authors in this journal are not necessarily those of the Editor or the Publisher. Please note that although care is taken in the preparation of this publication, the Editor and the Publisher are not responsible for opinions, views, and inaccuracies in the articles. Great care is taken concerning artwork supplied, but the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright.

2026 Senglobal Ltd./Volume 18 Issue 1 – Spring – 2026

08

FDA Unannounced Inspections and the Standard of Continuous Readiness: Insights from Patrick Nieuwenhuizen

On the Pharma Conversations podcast, Patrick Nieuwenhuizen explains how the FDA’s shift to unannounced overseas inspections requires constant GMP readiness.

Success depends on strong leadership, trained SMEs, simulation-based audits, and effective knowledge management embedded in daily operations.

10

Training & Education for Advancement within the Drug Discovery & Development Industry

The Bridges’ Dr. Marie W. Pettit emphasises the skills gap between academic training and industry requirements. Advocating stronger academia–industry collaboration, practical placements, and specialised regulatory and GMP training.

DRUG DISCOVERY, DEVELOPMENT & DELIVERY 14

Advancing Life Sciences with Automation: The Key to Faster, Safer and More Sustainable Drug Delivery

Emerson’s Nathan Pettus highlights how automation and smart data management are transforming life sciences manufacturing. Enabling flexible manufacturing, ensure product quality, support real-time release and improve sustainability, helping companies deliver safe, high-quality therapies to patients faster.

16

Project Management and Process Improvements for CDMOs

Brianna Kempfer at Cohance examines the strategic role of project management in CDMOs. Project managers coordinate complex, cross-functional teams, maintain client relationships and ensure compliant delivery of development and manufacturing programmes.

MANUFACTURING 18

Optimising Viral Vector Manufacturing by Building Scalable Platforms from Early Research to GMP Production

Optimising viral vector manufacturing requires integrating scalability, quality, and regulatory considerations from early research through GMP production. Susan D'Costa at Genezen explains how thoughtful early decisions on plasmids, cell lines, processes, and analytics enable efficient scale-up of AAV, LV, and RV vectors.

22

Gas Safety in Smaller Pharmaceutical Facilities

Megan Hine of Draeger Safety UK emphasises the critical role of gas safety in pharmaceutical facilities. Fixed detection systems protect personnel, prevent leaks, and reduce human error, while supporting operational efficiency.

24

Designing a Modern Biomanufacturing Model for Batch-to-Batch Consistency

Samsung Biologics’ Jaeyun Kim outlines a modern biomanufacturing model built on standardisation, simplification, and scalability. Integrating digital systems, datadriven processes, and plant equivalency enables CDMOs to support predictable performance and faster market delivery.

26

Certified ABS Plastics from Bio-Circular and Chemical Recycled Sources Instead of Fossil Ones

Luca Chiochia of ELIX Polymers explains how ABS plastics can be made from bio circular and chemically recycled feedstocks instead of fossil sources. Using ISCC+ mass balance and cracker integration, manufacturers maintain performance while www.international-pharma.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 1

Contents adding sustainable inputs, reducing fossil use, scaling recycling, and supporting circular plastics.

and engineering. Scott Beasley of Verista explains how managed services can provide scalable expertise for activities such as CQV, CSV and data management.

SUBSECTION: INTERPACK 2026

58

30

Always the Best Coating: Tablet Coating Engineering for Uniformity, Flexibility, and Resource Efficiency

Tobias Borgers highlights how tablet coating has evolved into a critical unit operation affecting performance, stability, and patient experience. L.B. Bohle’s enlarged drum coaters optimise mixing, spraying, and drying to achieve uniform coatings, reduce process times, and improve efficiency.

34

From Impossible to Circular: Unlocking Recycling Pathways for Pharmaceutical Packaging

Pharmaceutical packaging can transition from linear disposal to circular systems.

Edward Kosior at Nextek explores how through policy drivers such as PPWR and EPR, and technologies like supercritical CO₂ decontamination, the industry can develop safe recycling pathways for complex materials.

SUBSECTION: INJECTABLES 37

Annex 1, Sterility Assurance, and the Rising Bar for PUPSIT

The revised EU GMP Annex 1 elevates sterility assurance, making pre-use poststerilisation integrity testing (PUPSIT) a standard expectation for sterile filtration.

Steve Taliadouros of PCI explains how successful implementation relies on facility design, modular assemblies, and operator expertise.

40

Why You Can’t Design a Prefilled Syringe System Out of Components

Prefilled syringe development is often complex because systems are traditionally built by combining multiple components from different suppliers, creating regulatory, technical, and data-management challenges. Bettine Boltres of West Pharmaceutical Services argues that integrated prefilled syringe systems can simplify development.

42

The Platform Effect: Elevating Manufacturing Efficiency in Injectable Drug Delivery

Fill-finish in injectable drug delivery is increasingly complex due to biologics, gene therapies, and cell therapies requiring precise, sterile handling. Mark Glass, Director at Owen Mumford Pharmaceutical Services, explains that flexible platform devices streamline manufacturing.

CLINICAL & MEDICAL RESEARCH 44 Automated Liquid Handling to Advance 3D Cell Culture Imran-Ali Vasi at Eppendorf explains how automated liquid handling is advancing 3D cell culture in drug discovery. Automation improves reproducibility, standardisation, and scalability of spheroids, organoids, and organ-on-chip models.

47

Xenotransplantation: Regulatory and Ethical Considerations with Best Practices for Sponsors and IRBs

Xenotransplantation offers a potential solution to global organ shortages, WCG’s Ronald Quinton and Sharad Adekar examine how robust oversight, transparent informed consent, lifelong monitoring, and multidisciplinary collaboration are essential to manage risks.

50

Multiplex Antibody Array Technology: Advantages and Applications

Multiplex antibody array technology enables the detection of proteins with high sensitivity and minimal sample preparation. Eric Mennesson of Tebubio explains that by extending traditional ELISA principles, these arrays provide tools for proteome profiling, biomarker discovery, disease pathway analysis.

TECHNOLOGY 54

Building the Right Team and Resource Model to Support Quality System and Validation Activities

Successful quality and validation programmes in life sciences require multidisciplinary teams with expertise in operations, regulatory compliance, IT 2 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Five Ways AI Will Reshape Life Sciences in 2026: Why People, Process, and Purpose Matter Most

Chris Moore at Veeva Systems, explains how AI will reshape the life sciences industry by 2026. He predicts a shift from experimentation to practical implementation, focusing on people, processes, and connected data.

LOGISTICS & SUPPLY CHAIN 60

AI and Automation: The Secret to Faster and Safer Pharma Supply Chains

AI and automation are transforming pharmaceutical supply chains by improving efficiency, safety, and compliance, particularly in secondary packaging. Tjoapack’s Boy Tjoa explains how automation reduces manual errors and enhances traceability.

62

2026’s Biggest Pharmaceutical Supply and Logistics Talking Points

In this article, Ben Sharples of LogiPharma, outlines key pharmaceutical supply and logistics themes for 2026. He highlights three major focus areas: the growing role of AI in supply chain optimisation, the need for more resilient networks amid geopolitical uncertainty and tariffs, and the importance of improving global health access.

66

High Stakes, Higher Standards: Air Cargo and Pharma Integrity

The growing importance of air transport in pharmaceutical logistics means stricter cold chain control, real time monitoring, and regulatory compliance. Jordan Kohlbeck of IAG Cargo highlights digital technologies, specialised facilities, and resilient networks ensuring safe transport of temperature sensitive medicines worldwide.

68

Why Thermal Assurance Is the Key to a Resilient Cold Chain

Thermal assurance is essential for resilient pharmaceutical cold chains as supply networks face geopolitical disruption, climate change, and regulatory complexity.

Luiza Cervetto of Cold Chain Technologies highlights packaging, modelling, real time monitoring, and oversight to manage risk and ensure safe delivery worldwide.

SUBSECTION: NASAL & PULMONARY 73

The Role of Inhaled Therapies in the Fight Against Respiratory Syncytial Virus

Philippe Rogueda of Merxin explains that RSV remains a major global health challenge, particularly for infants, the elderly, and at risk adults. Inhaled therapies, including vaccines, proteins, and antibodies, form a third of the pipeline, with innovations improving efficacy, access, and at home treatment.

76

Facility spotlight: Device Design and Development at King’s Lynn

At Bespak’s King’s Lynn site, Thomas Daly, Tony Mallett, Shaun Williams, and Karl Bass lead inhalation device design and development. They combine simulation, virtual modelling, rapid prototyping, and material expertise to optimise pMDIs, DPIs, and autoinjectors, advancing efficiency, sustainability, and in silico testing for next-generation respiratory therapies.

80

Spray Pattern and Plume Geometry: Regulatory Convergence and Technological Innovation in Inhaled and Nasal Drug Products

Spray Pattern and Plume Geometry testing, long established in US guidance, are now included in updated European Medicines Agency guidance for inhaled and nasal products. Maria Smith of Proveris Laboratories highlights imaging and analysis tools supporting precise plume measurement and formulation development.

APPLICATION NOTE 32

Aseptic Robot-Based Radiopharmaceutical Filling

Stäubli explains how C Ray Therapeutics uses automated isolated lines with Stericlean robots to aseptically fill, inspect, and package radiopharmaceuticals. Operating in GMP Grade A cleanrooms, they ensure sterility, radiation containment, minimal human intervention, and efficient high quality production of targeted cancer therapies.

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INTERNATIONAL PHARMACEUTICAL INDUSTRY 3

Editor's Letter This spring edition of IPI focuses on several areas where innovation is actively shaping pharmaceutical development and manufacturing. In this issue, contributors look at how new preclinical tools, such as organ-on-a-chip systems, are improving the way researchers evaluate drug safety and efficacy before clinical trials. We also explore how automation and digital technologies are helping manufacturers streamline production and improve process control. Alongside this, the issue examines advances in injectable device platforms and the growing role of detailed aerosol characterisation techniques in the development of inhaled and nasal drug products. Together, these articles provide a snapshot of how scientific and technological progress is continuing to influence the way medicines are designed, produced, and delivered.

One thought-provoking article in this issue is by Ronald Quinton and Sharad Adekar at WCG. The piece explores xenotransplantation as a potential solution to global organ shortages while examining the significant regulatory and ethical challenges involved.

The authors highlight the need for robust oversight, transparent informed consent, lifelong patient monitoring, and strong collaboration between sponsors, regulators, and IRBs to manage risks such as immune rejection, zoonotic infections, and animal welfare concerns. I found this article particularly interesting because it clearly outlines the complex balance between scientific innovation and ethical responsibility.

Their insights make it easy to see how careful planning and ethical safeguards can help advance xenotransplantation safely and responsibly, offering hope to patients in urgent need of organs.

Another insightful contribution comes from Nathan Pettus of Emerson. This article explores how automation, advanced process control, and digital technologies such as real-time analytics and digital twins are transforming pharmaceutical manufacturing.

I found the discussion particularly compelling because it demonstrates how integrated data systems and automation are enabling more flexible manufacturing, improving product quality, and supporting real-time release strategies. At the same time, these technologies are helping organisations address sustainability goals by improving efficiency and reducing resource consumption across the manufacturing lifecycle.

Innovation in drug delivery and device development is also highlighted in by Mark Glass with Owen Mumford Pharmaceutical Services. As biologics, gene therapies, and other complex medicines continue to expand, manufacturing systems must be capable of handling a wider range of formulations and production requirements. The article explains how flexible platform-based devices can simplify fill-finish processes, reduce line changeovers, and streamline validation activities. This scalable approach supports efficient production while maintaining the high sterility and precision required for

injectable medicines, helping manufacturers respond more effectively to growing demand.

Finally, the Nasal & Pulmonary section includes an engaging piece from Maria Smith of Proveris Laboratories This article explores how regulatory expectations around spray pattern and plume geometry testing are evolving, particularly with the inclusion of these measurements in updated European Medicines Agency guidance. Advances in high-speed imaging and digital analysis are transforming these tests from simple visual assessments into sophisticated quantitative tools that provide deeper insight into aerosol performance. The article highlights how these technologies support formulation optimisation, device selection, and regulatory submissions while contributing to a stronger mechanistic understanding of inhaled and nasal drug delivery.

As the pharmaceutical industry continues to evolve, the themes explored in this issue will remain central to future progress. I hope the perspectives presented here provide valuable insight and encourage continued discussion across the scientific, regulatory, and manufacturing communities.

Alice Phillips, Editorial Manager

Editorial Advisory Board Bakhyt Sarymsakova, Head of Department of International Cooperation, National Research, Center of MCH, Astana, Kazakhstan

Rick Turner, Senior Scientific Director, Quintiles Cardiac Safety Services & Affiliate Clinical Associate Professor, University of Florida College of Pharmacy

Steve Heath, Head of EMEA – Medidata Solutions, Inc Patrice Hugo, Chief Scientific Officer, Clearstone Central Laboratories

Catherine Lund, Vice Chairman, OnQ Consulting

Jagdish Unni, Vice President – Beroe Risk and Industry Delivery Lead – Healthcare, Beroe Inc.

Heinrich Klech, Professor of Medicine, CEO and Executive Vice President, Vienna School of Clinical Research

Deborah A. Komlos, Principal STEM Content Analyst, Clarivate Diana L. Anderson, Ph.D president and CEO of D. Anderson & Company Franz Buchholzer, Director Regulatory Operations worldwide, PharmaNet development Group Francis Crawley. Executive Director of the Good Clinical Practice Alliance – Europe (GCPA) and a World Health Organisation (WHO) Expert in ethics 4 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Jeffrey W. Sherman, Chief Medical Officer and Senior Vice President, IDM Pharma Jim James DeSantihas, Chief Executive Officer, PharmaVigilant Mark Goldberg, Chief Operating Officer, PAREXEL International Corporation Maha Al-Farhan, Chair of the GCC Chapter of the ACRP

Robert Reekie, Snr. Executive Vice President Operations, Europe, Asia-Pacific at PharmaNet Development Group Sanjiv Kanwar, Managing Director, Polaris BioPharma Consulting Stefan Astrom, Founder and CEO of Astrom Research International HB

Spring 2026 Volume 18 Issue 1

www.international-pharma.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 5

Talking Point

Preparing for Change

A Look- Forward at the New UK Clinical Trial Regulations with Olive McCormick, Almac Group

On 28th April, the most significant overhaul of the UK’s clinical trial regulations in two decades will take full effect. These operational reforms aim to streamline the approval process and provide more agile routes to support innovation, but they also place immediate pressure on trials already in progress, particularly across supply, labelling and regulatory compliance.

In this Q&A, Olive McCormick, Director of Quality at Almac Clinical Services breaks down this change, delving into what sponsors need to address now as the enforcement date approaches and where gaps in readiness could create avoidable risk.

With the new UK clinical trial regulation introducing one of the biggest operational shifts in recent years, where do you see the greatest opportunities for sponsors to gain speed or efficiency in their UK trial programmes?

The new rules represent the most significant overhaul of the UK clinical trial regulations in over 20 years, and will drive impactful change across the board.

Notably, this includes the introduction of a streamlined, risk-proportionate approach to trial review.

through to close-out, sponsors are currently less focused on new trials and more concerned with transitional arrangements.

Under this framework, certain low risk studies can be classified as “notifiable trials,” provided they meet defined criteria.

These trials will benefit from an accelerated pathway, and the MHRA expect that around one in five studies will qualify for this fast-track notification route, allowing lower-risk trials to start sooner, enabling experts to focus on complex and early-phase studies.

Sponsors are primarily concerned about how their ongoing studies will be affected and how to ensure continuity of supply.

Some organisations are well prepared, have a strong understanding of the regulations, and have taken proactive steps to ensure a smooth transition. Others are less familiar and are at greater risk of non-compliance due to gaps in knowledge.

This creates a meaningful opportunity for sponsors. Faster approvals enable quicker study start-up, earlier patient access to investigational treatments, and improved overall programme timelines. This streamlined approach delivers clear efficiencies for sponsors while also benefiting patients.

What misconceptions or gaps in interpretation are slowing organisations down, and how can partners help close those gaps?

The MHRA’s ambition is clear: accelerate study start-up and bring more trials to the UK. From what you’re seeing across the industry, where are sponsors most in need of support to translate that ambition into operational readiness?

While the new regulations cover the full lifecycle of clinical trials, from initiation

One of the most significant misconceptions has been around the definition of “product already manufactured.” Early guidance suggested that such product could continue to be used after the April 28th deadline. However, this created uncertainty, as “manufactured” could be interpreted in different ways, such as the point at which the API was added or when the final labelling was applied. This ambiguity led to varying interpretations across the industry. Subsequent clarification confirmed that only product that had been QP certified prior to the deadline could continue to be used. Any product that is not certified and does not meet the new requirements cannot be used.

Another area of misunderstanding relates to the MHRA’s stated pragmatism. While there is flexibility within the framework, such as the ability to vary or disapply certain requirements, this is not automatic. Sponsors are required to submit a formal request with appropriate justification, which must be reviewed and approved. Some organisations have overlooked this step, assuming flexibility without recognising the need for regulatory approval.

Overall, the pace of regulatory change and the evolving nature of the guidance have contributed to uncertainty. Partners play an important role in helping sponsors interpret requirements, provide clarity, and implement practical, compliant solutions in a timely manner.

6 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Spring 2026 Volume 18 Issue 1

Regulatory & Talking Marketplace Point How did the MHRA engage with industry during the development of the new rules and the guidance?

The MHRA did engage with industry during the development of the guidance, including running webinars and consultation periods ahead of finalisation. However, many of the challenges only became evident once the regulations were applied in practice.

It is often the case that gaps and ambiguities only surface in real-world implementation. While these issues may appear more obvious in hindsight, it is not always possible to anticipate every scenario during the initial drafting phase.

One positive aspect has been the speed at which the MHRA has responded to industry feedback. Guidance documents have been updated iteratively, reflecting questions and challenges raised by sponsors and partners.

This level of responsiveness has not always been typical in the past. While the updates may not always align with every stakeholder’s expectations, the MHRA has made a clear effort to provide greater clarity and to apply a pragmatic approach as the industry works through implementation.

Have you seen sponsor companies facing challenges in adapting to the new guidance?

There is a broad spectrum with many sponsors being highly responsive and proactive from the outset, demonstrating a clear understanding of the requirements while others have required more prompting and engagement before taking action. There is a broad spectrum, ranging from organisations that are fully on top of the changes to those that need repeated encouragement to engage.

Significant efforts have been made to raise awareness through client outreach, meetings, and ongoing discussions. Despite this, one of the most consistent areas of concern has been labelling, which has become a key focus for many organisations as they work towards compliance.

With implementation moving at pace, sponsors are having to understand, plan and execute simultaneously. What practical steps are helping organisations stay compliant without delaying study timelines or first patient in targets?

In the pharmaceutical industry, any change is governed by formal change control, and www.international-pharma.com

the introduction of new regulations is no exception. The first step is to assess the regulatory change, understand its impact, and determine how it affects operations.

There is no substitute for a thorough familiarity with the regulations and guidance documents. While reviewing them may be timeconsuming, it is essential, as organisations cannot accurately assess impact or plan effectively without this foundation.

Once the regulatory baseline is established, applying structured change control processes is critical. This involves identifying required actions, assigning responsibilities, and ensuring readiness ahead of deadlines.

Equally important is having a strong, cross-functional team. Compliance cannot be managed by a single department such as QA or regulatory affairs; it requires collaboration across multiple functions to ensure both ongoing trials and future submissions are fully supported.

The UK CTR places pressure on operational timelines, particularly around labelling, product status, and NIMP requirements. How important is the role of partners in helping sponsors de-risk the supply chain?

Working closely with partners is critical, particularly because trials may be at very different stages. For trials nearing completion, the impact of the regulation may be minimal if no further manufacturing or changes are required. However, for active or earlystage trials, careful planning is essential.

Sponsors must assess which trials are in flight and determine their stage. Early-stage trials may allow time to update labels before finalisation, while later-stage trials require ensuring uninterrupted supply using existing QP-certified stock. If existing inventory is insufficient, sponsors must act promptly to manufacture and certify additional batches or implement new labelling. These processes are time-sensitive and require careful coordination.

NIMPs (non-investigational medicinal products), which are referred to as Auxiliary Medicinal Products in the EU, present an additional challenge. Previously, labelling guidance for these products was limited, but the new regulation introduces clear requirements without any transitional arrangements. Immediate action is therefore required to ensure compliance. Partners play a key role by helping sponsors prioritise actions, streamlining labelling strategies such as using

UK-specific labels, and reducing timelines wherever possible.

As we approach the enforcement date, what is the single most important action sponsors should take?

The single most important action is to fully understand the regulations, as there is no substitute for this foundational knowledge.

Once the regulations are understood, organisations should implement robust change control processes and involve the appropriate cross-functional teams. This includes clinical supplies, QPs, regulatory affairs, procurement, and planning.

Key focus areas include ensuring labelling compliance for both IMPs and NIMPs, maintaining full visibility of inventory and certification status, and planning regulatory submissions for any required variations or exemptions. Careful, proactive planning is essential to prevent supply interruptions and safeguard patient continuity. Organisations that have already adopted this approach are well positioned, however on the 28th April, those sponsors who are not prepared risk significant impact to patients due to interruption of supply for on-going trials.

Olive McCormick Olive McCormick is Director of Quality at Almac Clinical Services, where she is responsible for the Quality Assurance, Quality Control and the Regulatory Compliance in UK and Ireland. She joined Almac in 1998 and brings more than two decades of industry experience, with deep expertise in IMP manufacturing, packaging and labelling, global quality audits, and oversight of robust Pharmaceutical Quality Systems.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 7

Regulatory & Marketplace

FDA Unannounced Inspections and the Standard of Continuous Readiness: Insights from Patrick Nieuwenhuizen This industry article is from Pharma Conversations Podcast, hosted by Shada Warreth and Elizabeth Hunt.

This article was authored by Patrick Nieuwenhuizen, Managing Director Consultant at Paradigm Pharmaceutical Quality Consultancy. The views and opinions expressed are solely those of the author and do not necessarily reflect the positions of any affiliated organisations.

This episode was sponsored by Ecolab, whose support made production possible.

Sponsorship does not influence the content, discussions, or viewpoints presented.

Unannounced inspections have become one of the most transformative developments in the pharmaceutical regulatory environment, reshaping how companies think about compliance, operational discipline, and quality culture. In a recent episode of the Pharma Conversations podcast, Patrick Nieuwenhuizen – Managing Director of Paradigm Pharmaceutical Quality Consultancy (PPQC) offered a rich and detailed exploration of this shift. Drawing on decades of experience in sterility assurance, quality systems, and global regulatory interactions, Patrick provided a grounded, practical, and forward-looking perspective on what unannounced inspections mean for pharmaceutical manufacturers and how organisations can adapt to this new reality.

The conversation opened with a fundamental clarification: unannounced inspections are exactly what the term implies. As Patrick stated, “as it is in the word, it’s unannounced.” Unlike traditional inspections, which typically provide four to six weeks’ notice, unannounced inspections occur without warning. This means companies have no opportunity to prepare, reorganise, or rehearse. While European regulators such as the EMA and HPRA typically used unannounced visits for “triggered inspections” or “For Cause Inspection”, the FDA’s recent decision to extend this practice to overseas facilities marks a significant shift in regulatory strategy. Patrick 8 INTERNATIONAL PHARMACEUTICAL INDUSTRY

explained that the FDA “wanted to have a level playing field with US based companies, and not having the overseas companies the benefit to prepare themselves, as unannounced inspections are common in the US” ensuring that compliance reflects genuine day-to-day operations rather than the curated state often presented during scheduled inspections.

ensuring leadership presence, and managing ongoing operations without disruption. Under traditional inspections, these activities occur over several weeks; under unannounced conditions, they must occur within minutes.

The suddenness of the transition can be disorienting, particularly for personnel who have never experienced an inspection before.

This shift is already being felt in Ireland. As Patrick described, “all of a sudden the FDA… appeared on the doorstep of pharmaceutical companies within Ireland,” signalling a clear escalation in regulatory expectations.

The implications for manufacturers are profound. Companies must now operate under the assumption that inspectors could arrive at any moment, and their systems, behaviours, and documentation must be inspection ready every day, not just during the weeks leading up to a planned visit. This represents a fundamental change in mindset, requiring organisations to embed inspection readiness into their culture, processes, and daily routines.

A second challenge is the absence of a functional, well-rehearsed playbook.

Patrick stressed the importance of having a clear, actionable plan that outlines roles, responsibilities, and workflows. A playbook allows companies to “pull the trigger” and transition seamlessly into inspection mode.

Without it, organisations risk confusion, delays, and inconsistent communication issues that can quickly erode inspector confidence. He noted that companies must know “who is responsible for what,” from the receptionist who greets inspectors and inform key personnel, to the SME who explains a complex deviation. This level of clarity requires deliberate planning and regular reinforcement.

Patrick emphasised that this new reality demands a shift from episodic preparation to continuous operational discipline. “You need to be inspection ready at all times, and although a company must continuously adhere to GMP, now the process of inspection readiness must also be in place” he said, highlighting that activities traditionally deferred until an inspection was announced, such as tidying documentation, preparing SMEs, or rehearsing responses, must now be embedded into routine operations.

Even tasks that typically “only come up to the surface during a real inspection” must be maintained continuously. This requires a level of organisational maturity and cultural alignment that goes far beyond procedural compliance.

Drawing from his recent work supporting companies through unannounced inspections, Patrick identified several recurring challenges.

One of the most significant is the need for immediate organisational readiness. When inspectors arrive, companies must activate their inspection process instantly. This includes preparing the front room and back room, mobilising subject matter experts (SMEs), coordinating document retrieval,

SME preparedness is another critical area.

In scheduled inspections, SMEs often rehearse responses to complex deviations or historical issues, what Patrick referred to as “the hairy moments.” In unannounced inspections, SMEs must rely on their real-time knowledge and confidence. This can be daunting, especially when inspectors take a deeper dive into topics without warning. Patrick observed that personnel may “look into the headlights like a rabbit” when confronted unexpectedly, a reaction that can undermine credibility even when systems are fundamentally sound. Ensuring that SMEs are comfortable, confident, and capable of articulating their processes without preparation is therefore essential.

To address these challenges, Patrick strongly advocated for simulation-based training. A playbook alone is insufficient; companies must “stress test that playbook” and “stress test your personnel.” He recommended using internal audits as a platform to rehearse inspection behaviours, treating them like fire drills; unannounced, focused, and realistic. These simulations can target specific departments to minimise Spring 2026 Volume 18 Issue 1

Regulatory & Marketplace disruption while still building organisational readiness. However, he cautioned that internal audits often lack the rigour of real inspections, especially in smaller organisations where auditors and auditees work closely together. In such cases, external consultants can provide a more objective and challenging assessment, helping companies identify blind spots and build resilience.

The Irish pharmaceutical sector, Patrick noted, is well positioned to adapt to these changes. Ireland has a strong global reputation for pharmaceutical quality, supported by a highly respected HPRA inspectorate.

“Irish companies… perform at a very high standard,” he said, and many are accustomed to inspections from multiple international regulators. However, he acknowledged that the final 10% of readiness, the difference between good and exceptional, requires significant effort. The removal of preparation time exposes this gap, making continuous readiness essential. Companies must move beyond compliance as a scheduled event and embrace it as a daily operational reality.

A recurring theme throughout the interview was the role of leadership in shaping inspection readiness. Patrick emphasised that readiness must be driven “top down,” with senior management setting expectations, allocating resources, and modelling behaviours. Posters and slogans are insufficient; companies must invest in training time, SME development, playbook maintenance, knowledge management, periodic walkthroughs, and leadership visibility. He highlighted the importance of embedding inspection readiness into daily behaviours, noting that “there’s a bit of a difference between a routine operational day and an inspectional readiness day.” The goal is to eliminate that difference entirely, creating a culture where compliance is lived rather than performed.

Knowledge management emerged as one of the most critical and often overlooked elements of inspection readiness. Patrick warned that when SMEs leave or change roles, “that leaves you with a massive gap,” especially during unannounced inspections when their presence cannot be guaranteed.

Tacit knowledge - the deep, experience-based understanding held by SMEs is particularly vulnerable. Companies must invest in structured knowledge capture, SME succession planning, cross- training, and documentation that reflects real- world practice. This challenge is amplified by the unpredictability of unannounced inspections: “they might be www.international-pharma.com

on holidays,” he noted, underscoring the need for trained backups. Without robust knowledge management, even strong systems can falter under scrutiny.

Patrick also provided rare insight into the structure of recent FDA unannounced inspections in Ireland. Based on his knowledge, these inspections involved two inspectors, lasted five days, and included deep, comprehensive reviews rather than surface-level checks. Inspectors examined both general GMP compliance and productspecific issues, aiming to understand “how GMP is lived and followed through on a dayto- day basis.” This level of scrutiny reinforces the need for robust, well-documented, and consistently executed systems. Companies must be prepared not only to demonstrate compliance but to explain the rationale behind their processes and decisions.

For companies beginning their readiness journey, Patrick outlined a practical roadmap. The first step is to map the entire inspection process, from reception to closing meeting. Companies must define roles and responsibilities, prepare front room and back room operations, train personnel on how to interact with inspectors, conduct periodic walkthroughs, rehearse regularly, ensure SMEs and backups are trained and available, maintain documentation systems that allow rapid retrieval, and embed inspection readiness into daily operations.

He emphasised that leaders should not rely solely on spreadsheets or self- reported readiness metrics. Instead, they should “go out and about” to observe real conditions, adopting a GEMBA style approach to inspection readiness.

Looking ahead, Patrick noted that the EMA and HPRA do not currently plan to increase unannounced inspections, maintaining their risk- based approach. However, the FDA is expected to “up their game,” making unannounced inspections more common for overseas facilities. This shift requires companies to move from reactive to proactive compliance, transforming inspection readiness from a periodic activity into a continuous operational state. The organisations that succeed will be those that embrace this shift not as a burden but as an opportunity to strengthen their systems, culture, and resilience.

The interview concluded with a reminder that the biggest challenge companies face is ensuring that personnel “are not… staring like the rabbits in the headlights” when inspectors

Pharma Conversations Podcast Hosted by Shada Warreth & Elizabeth Hunt

arrive. Through preparation, practice, and cultural alignment, companies can meet this challenge and thrive in the new regulatory landscape. Patrick’s insights offer a clear message: unannounced inspections are not a temporary trend but a structural shift in regulatory oversight. Companies must evolve accordingly, embedding readiness into their culture, systems, and daily behaviours. In doing so, they not only meet regulatory expectations but also strengthen their operational integrity and long-term success. This shift toward continuous readiness ultimately represents an opportunity for organisations to mature their quality systems, deepen their process understanding, and reinforce the behaviours that support sustainable compliance.

By embracing this new paradigm rather than resisting it, companies can position themselves as industry leaders capable of demonstrating excellence at any moment. The organisations that internalise these lessons will be the ones best equipped to navigate the increasingly complex global regulatory environment.

Patrick Nieuwenhuizen Managing Director and Consultant at Paradigm Pharmaceutical Quality Consultancy (PPQC), with 30 years’ pharmaceutical industry experience and a Master’s in Pharmaceutical Microbiology from the University of Manchester. A quality professional specialising in microbiology and sterile manufacturing, with expertise across biologics, ATMPs, sterile fill-finish, and solid oral dose. Experienced lead auditor, risk facilitator, and co-author of PDA Technical Report 90 on Contamination Control Strategy.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 9

Regulatory & Marketplace

Training & Education Within Drug Discovery & Development Industry The drug discovery and development industry demands scientific rigour, strict regulation, and interdisciplinary expertise.

This field unites molecular biology, chemistry, pharmacology, toxicology, bioinformatics, clinical medicine, regulatory science, manufacturing, and commercialisation. Due to this complexity, training and education are essential for industry success.1 With rapid scientific innovation and evolving regulatory expectations, the industry relies on continuous professional development, interdisciplinary education, and workforce upskilling. Forwardthinking organisations understand that training is now essential throughout the professional lifecycle, from academic preparation to lifelong learning.2 This article encourages academics and industry leaders to recognise and strengthen the role, structure, and future direction of training and education in drug discovery and development to gain a competitive advantage.

Drug Discovery and Development Drug discovery and development is a multistage process, each with specific training requirements. Drug discovery involves target identification, hit discovery, and lead optimisation. Preclinical development covers pharmacokinetics, pharmacodynamics, toxicology, safety assessment, and chemistry, manufacturing, and controls (CMC). Clinical development requires expertise in phase I-III trials, biostatistics, data management, clinical operations, and medical monitoring. Careers in manufacturing and commercialisation demand knowledge of Good Manufacturing Practice (GMP), Quality Assurance (QA), and Quality Control (QC). Throughout development, scientists must follow regulatory guidelines for product approval.3 Earlycareer professionals need to understand applications such as Investigative New Drugs (INDs), New Drug Applications (NDAs), and Marketing Authorisation Applications (MAA) submissions. The process continues after product launch, with lifecycle management and pharmacovigilance essential for patient safety. Each stage requires specialised 10 INTERNATIONAL PHARMACEUTICAL INDUSTRY

scientific, regulatory, and operational training, highlighting the need for role-specific education pathways.4 Training for Industry Most professionals enter the industry through formal education in life sciences, pharmacy, medicine, or engineering. Undergraduate and postgraduate programs provide the core scientific knowledge, laboratory and analytical skills, research methodology, and critical thinking capabilities required in the scientific arena. However, academic curricula often provide limited exposure to regulatory science, GMP, and industrial workflows, creating a skills gap when graduates enter industry.5

Ongoing refresher training is required to address regulatory updates and inspection findings. Training is delivered in-house or through external career development courses funded by employers.

Industry Specific Training Industry-specific training is the key to bridging the gap between academia and industry.

Employers seeking qualified candidates must offer robust, targeted training, as many postgraduates currently lack essential skills for industrial roles. The pharmaceutical sector invests an estimated $2 billion annually in onthe-job training, underscoring its necessity for developing competent professionals in regulated environments. Such training – covering Standard Operating Procedures (SOP), instrument qualification, data integrity, ALCOA+ principles, and health, safety, and biosafety is critical to maintaining consistency, compliance, and inspection readiness.7 Organisations that prioritise these efforts are best positioned to succeed.

External training providers such as The Academia Industry Bridge, The Organisation for Professionals in Regulatory Affairs (TOPRA) and National Institute for Bioprocessing Research and Training (NIBRT) play a significant role in workforce development by delivering accredited short courses, professional certifications, customised corporate training, and digital learning solutions.

They complement organisational learning and development functions by providing specialised expertise, industry-recognised qualifications, and curricula aligned with evolving labour market, technological, and regulatory demands.8 Through flexible delivery modalities, including face-to-face, blended, and fully practical formats, external providers facilitate efficient upskilling and reskilling while reducing operational disruption. Their capacity to tailor programs to organisational and sectorspecific needs supports targeted capability development, leadership formation, and compliance, thereby contributing to workforce adaptability, productivity, and long-term organisational competitiveness. Professional training courses are often accredited or affiliated (e.g. International Organisation of Standardisation (ISO), professional bodies, regulatory endorsement). Accreditation, affiliation or endorsement ensures that training quality and consistency are maintained, it also demonstrates a recognition of competence of the staff and training centre as well as demonstrating regulatory credibility (ISO, 2016).

These providers are particularly important for small and medium size enterprises (SMEs) and biotech startups with limited internal resources.9 Although these training courses are at cost to the client or company, they are often substantially cheaper than companies training their staff in house.

Regulatory training is mandatory across drug development functions and includes GLP, Good Clinical Practice (GCP), GMP, and Good Pharmacovigilance Practice (GVP). These frameworks are defined by international guidelines and enforced by regulatory authorities (EMA / FDA / MHRA).

Scientists and Researchers Scientific training now transcends technical skills, equipping professionals with critical expertise in translational science, project management, cross-functional communication, and commercial and regulatory awareness.10 Organisations must

Doctoral and postdoctoral training are essential for innovation-driven roles in discovery and translational research.

However, traditional PhD programmes may not fully prepare scientists for industry decision-making, cross-functional collaboration, or regulatory requirements.

Many institutions now address this by offering industry placements and professional skills training.6

Spring 2026 Volume 18 Issue 1

Regulatory & Marketplace prioritise supporting professionals to become well-rounded contributors who can move research from laboratory to clinical trials and the market – essential for staying ahead.

Achieving success requires collaboration with discovery, clinical, regulatory, and commercial teams – an experience often overlooked in academic settings. Realise your full potential by pursuing diverse experiences across industry roles.

aims to protect participants, animals, and academic integrity, focusing on ethics, safety, and responsible conduct. Regulations are not typically governed by agencies like the MHRA. Documentation is principle-based with flexible protocols, and changes are approved quickly. Recordkeeping standards vary, and academia has a high tolerance for risk, with failures in early-stage research considered acceptable.

A major culture shock for those moving from academia to industry is the shift to project management. In academia, project management is often implicit and informal, typically led by principal investigators with limited formal training. In contrast, pharmaceutical companies employ dedicated, certified project managers with clear authority to enforce timelines and deliverables. This structured approach and defined hierarchy can be surprising for new recruits from academic backgrounds.11

In contrast, the pharmaceutical industry’s primary goal is to protect public health, consumers, and markets. Regulations focus on product safety, efficacy, quality, and liability, with commercialisation as a core objective.

Documentation is highly prescriptive and standardised, complying with GLP, GCP, or GMP as appropriate. Changes are slow and tightly regulated. The industry has a low tolerance for unknown risks, and deviations from protocols or failures are costly both financially and legally.

Cross-functional communication differs significantly between academia and industry.

Academic communication is typically relationship-based and informal, while pharmaceutical communication is role-based, structured, and decision-driven. Academics use exploratory language, such as “We should look into” or “we need more data,” whereas industry uses decision-focused terms like “go/no go,” “risk versus benefit,” and “what’s the mitigation.” This language gap can create barriers for recruits without industrial experience.12

CAPA is rarely used in academic settings except in some GLP or GMP laboratories.

In the pharmaceutical industry, CAPA is essential for GMP, GLP, and GCP laboratories regulated by ISO 9001, ISO 13485, the FDA, the EMA, and other authorities. Industry tracks all deviations, nonconformances, complaints, and audits. A preventive mindset is maintained through SOPs, automation, and daily monitoring. Academia differs significantly in this regard. Ongoing professional development is vital given the frequency of regulatory updates.14

Commercial and regulatory factors are key drivers of industry training, shaping every decision, whereas in academia, they are often secondary or absent. Academia focuses on knowledge generation, grants, and publications, whereas industry prioritises return on investment, revenue, and shareholder value. Regulatory oversight in academia is minimal and primarily ethical, while in industry, it is central and enforced across all stages by relevant authorities.8 These differences mean postgraduate students are often unprepared for industrial roles, creating a skills gap and increasing the need for company-led training and mentorship.

Challenges in Training and Education Training in academia and industry differs markedly due to variations in business acumen and cultural expectations. The challenge is not a lack of intellect, but of mindset and incentives. In academia, independent thinkers are developed, with success measured by publications, grants, and citations. In contrast, industry demands reliable contributors who prioritise process execution, compliance, quality, and collaboration to meet milestones and bring products to market. It is imperative for professionals transitioning to industry to adopt these priorities through targeted training and a commitment to professional growth. Those who do so will unlock rewarding and impactful careers.

Quality and Regulatory Professionals Quality and regulatory professionals must maintain expertise in global regulatory requirements, inspection readiness, riskbased quality management, change control, and corrective and preventive action (CAPA) systems.13 In academia, regulation primarily www.international-pharma.com

The most effective industry training in academic settings is through apprenticeships or internships, which provide students with hands-on experience in pharmaceutical environments. This practical exposure is often missing in academic laboratories.

Universities face challenges in providing training to industry standards; for example, students cannot validate analytical methods to ICH standards in short sessions.15 The required documentation and costs of intensive, industry-standard laboratory training are often impractical for academic institutions.

Training for industry careers is often insufficient. Industry uses structured onboarding with mandatory curricula and rolebased training matrices, and staff undergo annual recertification to maintain standards and minimise improvisation. Effective training includes three- to twelve-month placements in pharmaceutical or Commercial Research Organisations (CRO) settings, where fellows work on real deliverables. Training should cover SOP navigation, change control, crossfunctional meetings, and Quality-By-Design (QbD) practical courses focused on Critical Quality Attributes (CQAs) and regulatory compliance.16 It should also include riskbased decision-making, learning from real process failures, and writing industry reports for INDs and technical documents. Unlike academic writing, industry writing must meet regulatory requirements. Scientists should be trained for cross-team communication, for example a change in a formulation can directly impact the dissolution of a tablet.

If the two teams do not communicate changes effectively, then CAPAs can be triggered unnecessarily resulting in costly investigations.

The pharmaceutical industry expects staff to understand GMP, GLP, and GCP, follow SOP hierarchies, monitor deviations, report and document CAPAs, and ensure data is always audit-ready. Academia emphasises ethical conduct and scientific rigour but lacks formal quality systems and is more flexible in its approach to standardisation.

Process robustness and validation are critical in industry but not typically required in academia. Analytical methods in industry must be validated and reproducible across people, sites, and time, with defined acceptance criteria. Academic training focuses on proof-of-concept studies within a single lab, using informal standards.17 Practical Skills Gap Between Academia and Industry The purpose of practical laboratory training in academia is to learn and explore. The training supports hypothesis testing, skills development and experimental creativity and often mistakes are part of the learning process. Practical laboratory training in INTERNATIONAL PHARMACEUTICAL INDUSTRY 11

Regulatory & Marketplace the pharmaceutical industry is designed to produce reliable accurate data. The training supports patient safety, regulatory compliance and product quality. Mistakes must be prevented and not learned from.

Academia trains students in an informal, apprenticeship-style approach, often with flexible protocols and skills judged subjectively. Formal training within the pharmaceutical sector is based upon stepwise training; read SOPs, observe the trained operator, perform under supervision followed by an independent sign-off. Errors that occur in academia are corrected by repeating experiment’s and adjusting conditions whereas in industry it couldn’t be more different. An error will trigger a deviation report to find the root cause analysis and implementation of CAPAs. Use of equipment is rarely standardised in academia with servicing often ad-hoc and methods not going through a vigorous validation procedures. Pharmaceutical companies ensure their equipment and is serviced regularly, and all methods are validated to ICH Q14 guidelines.

Often in academia the training focuses on small-scale experiments for proof-of-concept success. Reproducibility across labs is rarely ever tested. The pharmaceutical industry works with Research and Development (R & D) small scale batches but must consider scale-up implications. Scale up challenges can be vast and affect solubility and stability of the final formulation. Technology transfer is essential when moving R & D formulations into the development phase, industry reports, batch records, specifications etc all need to be shared with the supporting laboratory.8 Sometimes in-house technology transfer is essential. The methods and formulation should be able to be reproduced at any different site of choice.

Practical training is assessed in academia by laboratory reports and competence is assumed after exposure. The assessments tend to be informal, and records are rarely audited except by an Ofsted inspector.

Training records are mandatory in the pharmaceutical sector and competency must be demonstrated to a line manager.

The training records must be auditable at any time requested by regulatory bodies.

Training and education are essential to the drug discovery and development industry. As science advances and regulatory scrutiny increases, organisations must invest in continuous, high-quality training 12 INTERNATIONAL PHARMACEUTICAL INDUSTRY

to support innovation, compliance, and patient safety. Well-trained professionals are crucial for delivering safe, effective medicines and ensuring long-term industry success. Significant differences exist between academic and pharmaceutical laboratories, including business acumen, attention to detail, regulatory standards, CAPA, and reporting requirements. Current training often falls short of industry standards, creating a global challenge for recruitment and career entry. Courses should prioritise industry standards, QbD, CQAs, and the validation of analytical methods in accordance with ICH, EMA, MHRA, and FDA standards. University graduates have advanced theoretical knowledge in their subject area but have seldom been exposed to industrial standards, timelines and practical accuracy. There remains a huge difference between the two working environments. This skills gap needs to be addressed with new training and courses accessible on a national and international scale.

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DiMasi, J. A. et al. (2016).’ Innovation in the pharmaceutical industry.’ Journal of Health Economics, 47, 20–33.

Maclean, N., Abrahmsén-Alami, S., Clark, C., Dörr, F., Florence, A., Ketolainen, J., Lindow, M., Mantanus, J., Rantanen, J., Reynolds, G., Robertson, A and Markl, S. (2026) ‘Empowering the Pharmaceutical Workforce for the Digital Future’. European Journal of Pharmaceutical Sciences: 107449.

Al-Madhagi HA. (2023) ‘FDA-approved drugs in 2022: A brief outline.’ Saudi Pharm J. 31(3):401-409 Franco, P., Jain, R., Rosenkrands-Lange, E., Hey, C and Koban MU. (2023) ‘Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries.’ Ther Innov Regul Sci. 57(3):484-514 Vieno, K., Rogers, K. A., & Campbell, N. (2022).

‘Broadening the Definition of ‘Research Skills’ to Enhance Students’ Competence across Undergraduate and Master’s Programs.’

Education Sciences: 12(10), 642 Fuhrmann, CN. (2016) ‘Enhancing Graduate and Postdoctoral Education To Create a Sustainable Biomedical Workforce.’ Hum Gene Ther.

27(11):871-879.

Torbett, R. (2022) Bridging the skills gap in the biopharmaceutical industry. Available at: bridging-the-skills-gap-jan-2022.pdf. Accessed 03/02/2026 Rikala, P., Braun, G., Järvinen, M., Stahre, J and Hämäläinen, R. (2024) ‘Understanding and measuring skill gaps in Industry 4.0 — A review.’

Technological Forecasting and Social Change.

201: 123206 Hall RL, Willging CE, Aarons GA, Reeder K. (2023) ‘Site-level evidence-based practice accreditation: A qualitative exploration using institutional theory.’ Hum Serv Organ Manag

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Leadersh Gov: 47(3):157-175 Cook, D. et al. (2014). ‘Lessons learned from the fate of AstraZeneca’s drug pipeline.’ Nature Reviews Drug Discovery, 13, 419–431.

Bauer, EA and Cohen, DE. (2012) ‘The changing roles of industry and academia.’ J Invest Dermatol: 132(3 Pt 2):1033-6 Ahmed, F., Fattani, M.T., Ali, S.R and Enam, R.N. (2022) ‘Strengthening the Bridge Between Academic and the Industry Through the Academia-Industry Collaboration Plan Design Model’ Frontiers in Psycology. 13: 875940 FDA (2023) Corrective and Preventive Actions (CAPA). Available at: Corrective and Preventive Actions (CAPA) | FDA. Accessed on 03/02/2026.

Ademola, A.J. (2025). ‘Data-Driven Corrective and Preventive Action (CAPA) Systems for Quality Assurance Optimization.’ International Journal of Advanced Multidisciplinary Research and Studies. 5. 907-926 Hajimiri, S.H and Soleymani, F. (2024) ‘Empowering the pharmaceutical industry by revolutionizing education.’ Daru: 3;33(1):3 Kumar, V., Nishal, S., Phougat, P., Garg, V., Dureja, H. (2024). Quality by Design and Marketing. In: Jain, N.K., Bajwa, N. (eds) Introduction to Quality

by Design (QbD). Springer, Singapore. https://doi. org/10.1007/978-981-99-8034-5_16.

Sharifi, S., Reuel, N., Kallmyer, N., Sun, E., Landry, M.P and Mahmoudi, M. (2023) ‘The Issue of Reliability and Repeatability of Analytical Measurement in Industrial and Academic Nanomedicine.’ ACS Nano: 10;17(1):4-11

Dr. Marie W. Pettit Dr. Marie W. Pettit has led the Medway Centre for Pharmaceutical Science for over eleven years, transforming it into a Commercial Research Organisation collaborating with pharmaceutical companies on innovative drug products.

She has trained postgraduate students to industry standards and founded The Academia Industry Bridge Ltd., creating a 12-week practical course that equips students to develop drug products using a Quality Target Product Profile, enhancing employability and bridging academia with industry.

Spring 2026 Volume 18 Issue 1

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INTERNATIONAL PHARMACEUTICAL INDUSTRY 13

Drug Discovery, Development & Delivery

Advancing Life Sciences with Automation:

The Key to Faster, Safer and More Sustainable Drug Delivery In the race to deliver life-saving therapies, the life sciences industry continually confronts unprecedented complexity and urgency. The challenge is clear: patients worldwide need novel drugs and vaccines, faster than ever before, without compromising reliable delivery, safety or quality.

Automation, combined with smart data management, has emerged as the foundation for this transformation, enabling pharmaceutical and biotech companies to accelerate discovery through commercial production, boost manufacturing agility, safeguard product quality, deliver a reliable supply of highquality products to market, and meet sustainability goals.

Almost 80% of biopharma leaders said in a 2023 Deloitte survey that their organisations needed to be more aggressive in adopting digital technologies, yet only 20% are making strides in digital maturity.1 Leaders with a datadriven mindset view data as a strategic asset, investing in automation and digitalisation – such as advanced process control, electronic batch records, innovative scheduling applications, integrated data platforms, digital twin simulation, machine learning and advanced analytics. These investments are already delivering significant benefits: reduced time-to-market, improved batch yields and enhanced regulatory compliance.

hampered by manual, paper-based processes and siloed data. Automation transforms research and development by accelerating technology transfers, standardising processes, scaling recipes and boosting flexibility. This enables real-time data sharing, rapid iteration and seamless tech transfer from discovery to clinical manufacturing.

Automated pilot plants and flexible manufacturing suites improve process optimisation, empowering scientists to quickly scale up high-impact molecules, while advanced analytics flag potential failures.

This acceleration can mean the difference between being first to market or missing critical patient needs.

2. Flexible Manufacturing The increased use of contract development and manufacturing organisations and innovation in complex biologics demand manufacturing systems that can adapt in real time. It can be challenging for traditional, fixed production lines to switch between small batches of high-value drugs.

A modern automation platform specifically designed for the life sciences industry can help manufacturers manage contextualised data and translate processes, workflows and drug recipes between products, minimising downtime and risk.

Automation, powered by modular equipment, recipe-driven batch control and digital twins, enables rapid changeovers, remote configuration and continuous manufacturing. A modern automation platform specifically designed for the life sciences industry can help manufacturers manage contextualised data and translate processes, workflows and drug recipes between products, minimising downtime and risk.2 3. Operational Integrity Manual interventions introduce variability – a significant challenge in life sciences where meeting the production schedule is critical and product quality is non-negotiable.

Automation enforces process control through closed-loop systems, real-time monitoring and electronic batch records.

To operate most efficiently and reliably, companies turn to real-time scheduling to calculate maximum run rates, perform capacity analysis and conduct “what if” testing on ways to drive greater operational performance. This technology provides realtime schedule updates, data reconciliation and white space analysis for additional production opportunities. In addition, realtime scheduling enables companies to better plan their maintenance. For example, one North American-based biopharmaceutical company that automated its planning process

Automation: Advancing Five Strategic Priorities There’s no question – a digital-first approach with smart data management is essential for building the next generation of biopharmaceutical plants. Digitally mature plants are best positioned to deliver new therapies at unprecedented speed and scale while reliably supplying the market. But how specifically is automation changing the game?

Let’s look at how automation addresses five critical priorities for the life sciences industry: 1. Pipeline Acceleration Innovation in drug development is often 14 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Spring 2026 Volume 18 Issue 1

Drug Discovery, Regulatory Development & Marketplace & Delivery reduced time spent on maintenance by 95% compared to manual efforts. In addition, it ensured all critical equipment was available and ready to go when production plans called for it.

4. Real-Time Release Traditional batch release is cumbersome, requiring extensive manual sampling, testing and review of documentation. Automation and advanced data analytics reimagine this process with continuous process verification, in-line monitoring, real-time control of quality attributes, and fully electronic records that support real-time release. Real-time release automatically reduces batch release times and minimises the risk of errors, potentially leading to a reduction of more than 30% in manufacturing cycle time, according to EY.3 The organisations charged with product quality are seeing the benefits. The U.S. Food and Drug Administration’s Process Analytical Technology framework encourages the use of automation to monitor critical quality attributes in real time. Leveraging automation in this way helps reduce the impact of siloed data and the need for end-of-process testing and manual review, driving product consistency and traceability, fewer recalls and faster lot release.

5. Sustainable Operations In recent years, sustainability has become a board-level priority. Data aggregation, contextualisation and visualisation in conjunction with automated systems can be used to optimise energy and water usage and enable more efficient closed-loop clean-inplace and steam-in-place processes. Digital twins and simulation tools identify process inefficiencies up front, while predictive maintenance reduces unplanned downtime and waste.

The Foundation: Data Management Finally, data with context is a foundational component to achieve digital maturity and gain the most value from automation technologies. The volume and variety of data generated across the drug development and manufacturing product lifecycle are vast and growing exponentially. Without a unified approach to data management, organisations risk data silos, inconsistencies and missed opportunities for process improvement. A robust data management strategy ensures data from disparate sources – sensors, laboratory systems, manufacturing execution systems and enterprise resource planning platforms – is integrated, contextualised and available in real time. www.international-pharma.com

Despite its vital role as a solution, the potential of automation is limited by today’s current architectures that were designed with data siloed by department – production, reliability, safety and sustainability. This compartmentalisation creates islands of fragmented data that are difficult to use with today’s analytics software and new AI applications.

As we work to meet accelerating demand, C-suite leaders must champion a data-driven mindset. After all, when data is treated as a strategic asset, the organisation is equipped to innovate faster, adapt to market needs and deliver safe, effective therapies to patients worldwide.

This challenge – and the opportunities we’ll unlock by addressing it – has created the need for a new software-defined, OT-ready enterprise operations platform designed to integrate and contextualise data to optimise operations.4

1.

For pipeline acceleration, data needs to flow freely to speed tech transfer and help scale at every stage. Data integrity is critical for flexible manufacturing to easily interchange components, scale recipes and create simulation models to test new strategies. When it comes to operational integrity, you need good data to prove processes, get access to data to track down and fix anomalies, and show that assets were calibrated and working correctly, enabling real-time release. In-line analytics and reliable batch records also require seamless data and work better as part of an existing ecosystem. And finally, if companies have siloed areas of quality, reliability, energy use and emissions data, they don't have true visibility into their operations, making it hard to run efficiently and sustainably.

A Call to Action for Life Sciences Leaders For life sciences companies, automation and data management are more than tools for efficiency. This one-two punch is the foundation of future competitiveness, resilience and patient impact. Investing in automation is an investment in agility, safety and the ability to impact more patients.

REFERENCES

2.

3.

4.

https://www.deloitte.com/content/dam/assetsshared/legacy/docs/perspectives/2022/gx-lifesciences-outlook-2023-digital-transformation. pdf https://www.emerson.com/en-us/industries/ automation/life-sciences-medical https://www.ey.com/en_us/insights/lifesciences/unlocking-efficiency-in-pharma-withrtr-technology https://www.emerson.com/en-us/expertise/ automation/enterprise-operations-platform

Nathan Pettus Nathan Pettus was named president of Emerson’s Process Systems and Solutions business in June 2021. As president, Pettus oversees a business that helps some of the world’s leading companies in a wide variety of industries leverage automation software and technologies to optimise operations, protect personnel and reach sustainability targets. Pettus received a Bachelor of Mechanical Engineering degree from Tennessee Technological University, a master’s degree in Controls Engineering from University of Texas at Austin and holds a master’s degree in business administration from the McCombs School of Business at University of Texas at Austin.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 15

Drug Discovery, Development & Delivery

Project Management and Process Improvements for CDMOs The Strategic Role of Project Management in CDMOs Contract Development and Manufacturing Organisations (CDMOs) operate in a highly competitive landscape where a company’s quality, speed, and customer experience are vital differentiators from its competitors. As the biotechnology and pharmaceutical industry grows, CDMOs must execute development and manufacturing projects, for candidates ranging from biologics to highly specialised active pharmaceutical payloads, with precision, while maintaining scalable and compliant operational systems.

The function of Project Management within a CDMO is not simply limited to schedulers or administrative support; it operates at the intersection of complex technical operations, quality systems, and customer-facing execution. Project Management teams ensure not only that timelines and budgets are met, but also that the development, technology transfer, and manufacturing activities required to produce clinical or commercial materials proceed in a reliable, compliant, and coordinated manner.

Project Managers (PMs) are mission-critical to managing client-sponsored projects and are equally essential to identifying gaps and driving improvements that strengthen the CDMO’s long-term performance. Their cross-functional vantage point enables them to drive day-to-day project success, while simultaneously providing the insight needed to facilitate process improvement initiatives across the organisation’s various departments.

Project Managers as Integrators Across Technical and Client Interfaces The projects that a CDMO undertakes are inherently cross-disciplinary. Bringing a molecule from early development into scalable manufacturing involves subject matter experts (SMEs) across multiple functions within an organisation, each working under different mandates, constraints, and timelines. An important role of a PM is therefore to serve as an integrator of the cross-functional team, 16 INTERNATIONAL PHARMACEUTICAL INDUSTRY

ensuring that functional teams operate within a cohesive strategy, rather than in parallel efforts, to achieve a common goal.

Additionally, a PM helps translate scientific requirements into actionable project plans, clarifies responsibilities, manages dependencies, and ensures that bottlenecks are identified early enough to avoid or minimise disruptions or delays to the project. In many CDMOs, this integrative role becomes the deciding factor between a smooth technology transfer and one that fails under the weight of unresolved issues and late-stage surprises.

Importantly, PMs also create the ‘connective tissue’ between the client and internal teams. They serve as advocates for internal teams by setting realistic expectations with clients and ensuring that external demands do not compromise compliance or operational stability.

Conversely, they serve as advocates for the client within the organisation by ensuring that commitments are honoured, issues are escalated early, and project needs remain visible across leadership levels, while maintaining customer satisfaction.

The PM as Guardian of Client Trust and Relationship Management The client-facing nature of CDMO’s work further elevates the importance of PMs. Client satisfaction, communication, and trust are key drivers of revenue, repeat business, and longterm partnerships, particularly because CDMO engagements often span multiple phases of a product’s lifecycle. Alongside the business development lead or partnership manager, the PM serves as the primary guardian of the client relationship, ensuring transparent communication and alignment between the client’s expectations and the realities of the science and good manufacturing practice (GMP). PMs must therefore balance speed, cost, and compliance, often negotiating difficult trade-offs.

It is important to note that in most CDMOs, PMs typically manage multiple projects for multiple clients simultaneously.

For example, when a client requests an accelerated timeline for clinical supply or a regulatory filing, the PM must coordinate an

evaluation of tasks across both the specific project and the broader client portfolio before committing to accelerating the timeline. This requires input from multiple stakeholders to assess the impact of not only the individual project, but also on the wider organisation, particularly if other ongoing or planned projects may be affected.

The PM communicates risks transparently and helps clients understand how technical constraints interact with regulatory requirements. When done effectively, the PM becomes a trusted advisor whose proactive management reduces a client’s anxieties, improves transparency, and builds long-term loyalty.

Cross-Portfolio Visibility and PM-Driven Process Improvement Beyond their primary responsibility for project oversight, PMs are uniquely positioned to identify process inefficiencies, as they have full visibility across various projects and clients within the network, from early phase development to commercial manufacturing.

While functional teams typically see issues within their own domains, PMs can observe patterns or bottlenecks across many projects and clients. They see where delays occur, which handoffs consistently fail, where documentation accumulates, when communication gaps arise, and which quality processes routinely create bottlenecks.

This vantage point allows PMs to prioritise improvements that will yield a high rate of return (ROI) for the project and align them with strategic and organisational objectives. PM-led improvement initiatives may focus on addressing the root cause of reoccurring deviations, improving supply chain predictability, reducing batch record preparation and execution cycle times, and testing capacity, to name a few.

As primary guardians of the relationship, PMs are typically the first exposed to this feedback and are therefore best positioned to advocate for improvements that enhance the client experience by strengthening internal processes. For instance, some CDMOs have implemented standardised client communication cadences – weekly operational reviews, monthly steering committees, and Spring 2026 Volume 18 Issue 1

Drug Discovery, Regulatory Development & Marketplace & Delivery quarterly executive updates – based on PM recommendations. These communication cadences help prevent misalignment, reduce the frequency of escalations, and provide clients with greater visibility into risks and timelines, ultimately increasing client satisfaction. Some organisations will also incorporate project completion surveys to capture client feedback, including an open-ended section for additional feedback or suggestions. This feedback can then be translated into targeted improvement initiatives to address identified gaps and bottlenecks.

Embedding Operational Excellence through PM Methodologies PM involvement in process improvement reinforces operational maturity. PMs naturally think in terms of dependencies, workflows, risk mitigation, and measurable outcomes.

These skills align well with Lean and Six Sigma methodologies commonly used in manufacturing optimisation. When PMs apply structured root cause analysis, risk management tools, or visual management boards, they help embed consistent problemsolving habits across teams, which can then be applied to day-to-day challenges.

Their focus on integrated planning and measurable progress makes improvement efforts more actionable and sustainable. As PMs are accustomed to translating complex technical information for clients, they also excel at explaining the rationale behind improvements to internal stakeholders and ensuring adoption.

PMs are also able to communicate internal improvements to clients, demonstrating accountability and an organisational commitment to continuous improvement.

Turning Project Insights into EnterpriseLevel Knowledge By leveraging PMs’ cross-functional visibility, organisations can more effectively turn lessons learned from individual projects into enterprise-wide knowledge. PMs can identify common issues across multiple clients – such as delays in equipment turnaround, inconsistencies in change control timelines, or recurring analytical bottlenecks – and elevate those trends to senior leadership with evidence drawn from real project data. This practice helps CDMOs prioritise improvement initiatives that yield the greatest return, rather than relying solely on anecdotal feedback or isolated functional perspectives.

In one example, a PM within a manufacturing organisation benefited significantly from establishing a structured lessons learned process that was implemented and maintained www.international-pharma.com

across multiple portfolios. By systematically identifying recurring patterns, dependences, and operational impacts, the PM was able to anticipate potential bottlenecks and develop targeted mitigation strategies. This preparation enabled the technical teams to proactively address chemistry-related challenges and maintain alignment with critical milestones.

As a result, the project remained on schedule and achieved on-time material delivery.

Daily Delivery and Long-Term Organisational Advancement Ultimately, PMs are indispensable not only because they ensure project delivery but because they help CDMOs evolve from using reactive, project-by-project execution models into proactive, scalable, and client-centric organisations. From the project perspective, PMs protect the critical path, translate scientific uncertainty into executable plans, and maintain transparent communication with clients so that trade-offs among speed, cost, and compliance are explicit and agreed. The result is a virtuous cycle in which strong project delivery generates the data and credibility needed to drive operational improvements, and those improvements, in turn, make subsequent projects faster, safer, and more predictable.

This dual mandate compounds value because lessons learned in one program become standard work in the next; each success increases predictability, reduces deviation rework, and shortens cycle time to disposition. Just as importantly, PMs build trust inside the organisation by creating clarity and fairness in how work is prioritised and how decisions are made. Over time, consistent PM behaviours – honouring commitments, sharing data rather than anecdotes, closing the loop on actions, recognising functional constraints publicly –create a reputation for reliability that elevates the CDMO’s execution culture.

That trust is contagious: clients extend more latitude during inevitable variability when they see disciplined governance and candid risk management, while internal leaders are more willing to invest in automation, digital tools, and training when PMs demonstrate measurable returns through improved metrics such as On-Time In-Full (OTIF), Requests for Tender (RFT), and cycle-times.

For example, a project manager within a CDMO demonstrated effective stakeholder management by engaging in transparent discussions with a client regarding technical challenges, cost implications, and timeline constraints. Through structured technical

teleconferences, the project manager provided clear visibility into the budgetary and scheduling impacts of continuing under a plan governed by the initial scope of work. This openness increased the client’s willingness to proceed with a change order and supported more informed downstream communications. As a result, the client’s internal teams were able to adjust their plans for downstream activities without incurring additional costs.

PMs as Stewards of Quality, Compliance, and Organisational Integrity In an industry where the stakes include patient timelines and regulatory scrutiny, PMs are not merely coordinators of effort but stewards of organisational integrity—knitting together science, quality, compliance, and operations into a system that clients and patients trust.

By empowering PMs to lead both execution and improvement, CDMOs establish the trust, reliability, and operational resilience required to thrive in an industry where flawless delivery directly impacts patients’ lives.

Empowering PMs to own both the project and the process shapes a CDMO’s long-term reputation, competitiveness, and ability to deliver life-changing therapies at scale. The Project Manager ensures CDMOs deliver with scientific rigor, in an industry where flawless delivery directly impacts patients’ lives.

Brianna Kempfer Brianna Kempfer, Ph.D., is senior director of project management at Cohance, where she leads complex, cross-functional initiatives that support operational integrity, regulatory alignment, and organisational performance across the global pharmaceutical landscape. Dr. Kempfer has been active in the pharmaceutical CDMO industry since 2012, where her professional background has spanned quality control, operational excellence, and project management. Dr. Kempfer gained a doctorate in business administration, with a specialisation in project management, from Capella University, Minneapolis, and was earlier awarded a master’s from Saint Leo University, Saint Leo, and a bachelor’s from Newberry College, Newberry.

Email: brianna.kempfer@cohance.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 17

Manufacturing

Optimising Viral Vector Manufacturing by Building Scalable Platforms from Early Research to GMP Production Cell and gene therapies (CGTs) are redefining what is possible in modern medicine, offering innovative and potentially curative treatments for diseases that were once considered untreatable. Scientific innovation across adeno-associated virus (AAV), lentivirus (LV) and retrovirus (RV) viral vectors has accelerated rapidly, driving a growing and increasingly diverse clinical pipeline.

While science and CGT innovation have moved quickly, manufacturing often still remains a critical rate-limiting step. High-quality viral vectors are the backbone of CGTs, and the ability to scale their production reliably, reproducibly and compliantly is key to determining how quickly and efficiently a promising therapy reaches patients.

Scaling a viral vector from early research to good manufacturing practice (GMP) production is a multi-step journey that transforms innovative science into viable, commercial-ready processes and products. From plasmid sourcing to analytical design, each decision made along the way creates either friction or momentum for the future. The most successful CGT programmes are those that start with the end in mind, building scalability, quality and regulatory confidence into development from the outset.

This article explores the key stages of viral vector scale-up and examines how early technical and strategic choices can strengthen quality, protect timelines and set the foundation for long-term success.

Viral Vector Challenges and Opportunities The CGT sector is maturing with a growing number of approved therapies, alongside a surge in clinical programmes targeting both rare and more prevalent diseases. As of the end of 2025, 38 gene therapies, 36 RNA therapies and 71 non-genetically modified cell therapies have been approved globally for clinical use.1 This reflects increasing regulatory confidence and technical progress.

For small and mid-sized biotechs, this 18 INTERNATIONAL PHARMACEUTICAL INDUSTRY

momentum presents a significant opportunity but also new operational pressures.

Viral vectors sit at the heart of the challenges associated with CGT development and manufacturing but also offer the potential for strategic opportunities. Demand for AAV, LV and RV vectors continues to rise across therapeutic areas such as oncology, neurology and rare genetic disorders. Although all the vector types share common manufacturing processes, each specific type has its own set of unique challenges. Developers must also navigate increasingly complex expectations around manufacturing consistency, analytical rigor and GMP compliance.

The viral vector manufacturing landscape has evolved to meet this demand. Contract development and manufacturing organisations (CDMOs) now offer end-to-end services and advances in platform processes and analytics are improving yields and reproducibility while helping reduce the cost of goods.

However, this expansion has been uneven.

Industry consolidation is accelerating, with some CDMOs narrowing their focus or exiting viral vectors entirely, and commercial-scale experience remaining limited.

For emerging and mid-size biotechs with finite resources and tight financial budgets, selecting the right manufacturing partner has become as strategically important as the science itself. Capacity alone is no longer enough. Partners must be able to translate early innovation into scalable, commercialready manufacturing.

Start with the End in Mind by Scaling as a Design Principle Scaling a viral vector is often framed as a laterstage development problem or something to address once clinical proof of concept has been achieved. In practice, scalability is a design principle that should be embedded from the earliest stages of development.

Early planning begins with understanding the target patient population. A rare disease programme may only require a 50 L GMP run, while broader indications can demand bioreactor volumes of up to 2,000 L. Processes that can flex across this range are better positioned to avoid costly reinvention later.

While AAV, LV and RV vectors share common manufacturing fundamentals, each presents unique scale-up challenges: •

AAV: Scaling AAV production can lead to declines in yield and consistency if transfection efficiency is not carefully maintained. Early optimisation of transfection parameters, such as enhancers, sensitisers and reagents, helps preserve performance as volumes increase. For very large-scale programmes, alternative production systems, including packaging or producer cell lines and Sf9 baculovirus platforms, can further improve reproducibility and volumetric productivity.

•

LV and RV: These vectors are more fragile than AAV vectors, making them particularly sensitive to processing time and shear stress. Scale-up strategies must prioritise streamlined, shear-aware downstream workflows.

Appropriately sized filters, well-tuned chromatography systems and simplified processing steps help protect vector integrity and maximise recovery across scales. For in vivo applications, additional development complexity can arise when envelope modifications are introduced to achieve specific tropism, requiring careful consideration of process compatibility and consistency as programmes scale.

Additionally, embedding Quality by Design (QbD) principles early allows developers to overcome technical hurdles and treat scaleup as an opportunity to strengthen process robustness and accelerate the path to patients.

Upstream Decisions That Define Downstream Success Some of the most consequential scaleup decisions are made long before GMP manufacturing begins. Early material choices directly influence manufacturability, comparability and regulatory risk include: •

Plasmids: GMP-grade plasmids are critical, with production timelines measured in months rather than weeks.

Engaging plasmid vendors early can Spring 2026 Volume 18 Issue 1

Manufacturing prevent missed manufacturing slots and downstream delays.

methods capable of accurately measuring potency, infectivity, purity and safety.

•

Cell lines: Access to licensed master cell banks reduces supply risk and supports smoother technology transfer as programmes advance. Early alignment on cell substrates also simplifies later comparability assessments.

•

Starting materials: Choosing scalable, GMP-compatible materials from the outset reduces the likelihood of rework and re-qualification in later phases.

The greatest advantage for biotech developers comes when these analytical tools are embedded early rather than retrofitted later. Fit-for-purpose assays aligned with QbD principles allow teams to track critical quality attributes (CQAs) throughout development, ensuring that each scale-up decision is grounded in meaningful data.

In contrast, a speed-first, “quick and dirty” approach to early development may enable rapid entry into first-in-human trials but frequently creates challenges when processes must later be uplifted to support late-phase or commercial manufacturing. When early processes are not designed with GMP and QbD in mind, additional optimisation is often required, along with additional cost, time and risk.

Analytical Rigor as a Foundation for Regulatory Confidence As viral vector programmes progress, robust analytics become the backbone of both process understanding and regulatory success. Regulators, including the FDA and the EMA, expect validated, phase-appropriate

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This continuity is essential as programmes move from first-in-human studies toward commercial readiness. Analytical methods should evolve alongside the process, supporting comparability, consistency and the generation of strong chemistry, manufacturing and controls (CMC) documentation for Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) submissions. Early investment in analytical rigor not only de-risks scaleup but also builds regulatory confidence and preserves optionality as programmes advance.

The Twin Constraints of Speed and Cost Even with strong technical foundations, two pressures consistently shape viral vector development: speed and cost.

Legacy production processes remain a major contributor to high therapy costs and

prolonged timelines, while rising prices for GMP-grade plasmids and transfection reagents can further strain early-stage budgets.

For small and mid-sized biotechs, speed is often non-negotiable. Advancing to firstin-human trials quickly can unlock funding, partnerships and validation. However, moving too fast without sufficient planning frequently results in inefficiencies and rework that ultimately slow progress.

Cost and speed are tightly linked. Poorly optimised processes increase cost per dose, while delays in materials or analytics can cascade into missed milestones. When combined, these two factors can significantly impact the delivery of CGTs to patients who need them. Balancing these pressures requires strategic efficiency rather than shortcuts.

Practical levers for balancing speed and cost include: • • • •

Running process development, analytical method development and plasmid procurement in parallel Initiating GMP plasmid production as early as possible in development Designing processes at the right scale for the intended patient population Applying a single, commercial-ready

INTERNATIONAL PHARMACEUTICAL INDUSTRY 19

Manufacturing quality system in a phase-appropriate way When executed well, these strategies can help compress timelines without compromising quality or compliance.

Partnerships That Enable Viral Vector Progress Given the complexity of viral vector scale-up, collaboration has become a defining strength of successful CGT programmes. Strategic CDMO partnerships now play a central role in development, enabling biotechs to combine innovation with the manufacturing expertise needed to progress confidently toward the clinic and beyond.

A true value-adding CDMO partner brings more than manufacturing capacity.

Commercial manufacturing experience, regulatory fluency and analytical depth allow early decisions to be informed by late-phase realities. Equally important are transparency, flexibility and communication.

For emerging biotechs, their programme is often their entire company. Effective partnerships are built on trust, clear escalation pathways and consistent project management. Dedicated project managers, regular steering meetings and direct access to technical experts and leadership help ensure alignment and minimise surprises.

Flexibility is another differentiator.

Programmes evolve, funding cycles shift and priorities change. Partners who can structure work in stage-gated phases, adapt technical approaches and explore creative financial models help biotechs maintain momentum without overextending resources.

Looking Ahead and Building the Next Generation of Viral Vector Platforms The future of viral vector manufacturing lies at the intersection of technical innovation and collaborative execution. Emerging approaches, including synthetic DNA, stable producer cell lines, advanced transfection enhancers and digital analytics, promise improvements in productivity, consistency and scalability.

However, technology alone is not enough to realise the full potential of CGTs. The most successful programmes will be those that integrate these tools into thoughtfully designed platforms, guided by data and aligned with long-term commercial goals.

Equally, partnership models must continue to evolve. Transparency, shared ownership 20 INTERNATIONAL PHARMACEUTICAL INDUSTRY

of risk and early alignment on end goals will define the collaborations that turn promising science into approved therapies.

From Scale-Up Challenges to Strategic Opportunities Optimising viral vectors is rarely just a question of increasing production volume. It is about designing processes that can stand up to scale, scrutiny and regulatory expectations. When scalability, quality and analytics are built in early, developers can carry innovative science forward into GMP manufacturing with greater confidence.

In an increasingly competitive CGT landscape, these early decisions determine both the speed to clinic and also the likelihood of long-term success. With the right strategy, the right data and the right partners, viral vector scale-up becomes less of a bottleneck and more of a catalyst for delivering lifechanging therapies to patients.

REFERENCES 1.

https://www.asgct.org/uploads/files/general/ Landscape-Report-2025-Q3.pdf

Susan D'Costa Dr. Susan D'Costa is a molecular virologist with over 25 years of experience, including more than a decade in viral vector gene therapy. Her expertise spans viral vector analytics, process development, manufacturing, and team building. Before joining Genezen, Susan was CTO at Alcyone Therapeutics, leading viral vector CMC, device development, and technology partnerships.

Spring 2026 Volume 18 Issue 1

www.international-pharma.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 21

Manufacturing

Gas Safety in Smaller Pharmaceutical Facilities

The use of gases is both fundamental and commonplace within the pharmaceutical and biopharmaceutical industries, used in a variety of settings, from the production process to essential sterilisation or decontamination procedures. But each gas required in these processes is accompanied by risks and can pose significant hazards to the health of employees, and sometimes to the safety of the whole facility. Gas safety is therefore a critical consideration in the sector, with constant and reliable gas monitoring and detection needed to protect personnel and plant from the buildup of higher concentrations of gases or environments where oxygen displacement can occur, either through accidental releases or leakage. This makes the implementation of a reliable gas detection system in the pharmaceutical industry crucial.

The approach and type of system used will normally depend on the complexity of the setting, and this is likely to be different in smaller pharmaceutical facilities or science laboratory settings than it would be in a large production facility.

The wide variety of gases and the different ways they are used, combined with the potentially high-risk nature of the

hazards involved, can make gas safety seem a challenging area, further complicated by regularly evolving legislation and advice.

safeguards must be taken to protect the health of personnel from the toxic effects of hydrogen peroxide.

As a result, it can be difficult to know the best approach to take to ensure that the highest standards of safety are maintained.

This is particularly true in smaller settings, not least because in such environments, health and safety knowledge (and resources) may be less comprehensive. This contrasts with, for example, a multinational pharmaceutical company, which may well have a large global health and safety team with specialists in gas detection.

Gas detection has two applications in this example. In the first instance, to monitor levels inside an isolator or other enclosure to ensure that the required concentration is reached and maintained for the required length of time, and once the decontamination is complete, the sensor will ensure the absence of hydrogen peroxide before the isolator is opened. The detector is attached to a small control panel that identifies the presence of hydrogen peroxide and indicates when it is unsafe to enter an area.

For this reason, finding the right gas detection system for the task and working in partnership with an experienced and reputable provider to find the best solution can be particularly valuable within smaller or less complex facilities.

Example: Bio-Decontamination of Isolators or Enclosures Hydrogen peroxide is a powerful disinfectant and sterilant for decontaminating equipment, facilities and medical devices, and is frequently a preferred substance for these processes due to its bioactive effect in killing bacteria.

While effective decontamination is essential in the pharmaceutical industry,

Secondly, gas detection is required for ongoing monitoring to alert personnel to leaks and enable action to be taken and accidents to be prevented.

If there is a leak, the gas detection system can be set up to automatically shut off the gas supply, preventing the situation from escalating. The system will also automatically shut off the vaporiser and turn on ventilation systems to help disperse the gas.

At the same time, both audible and visual alarms will be triggered, such as a siren and flashing beacon, so that personnel can act quickly secure the area and safeguard colleagues.

This example also provides a useful reminder about the way in which welldesigned gas detection systems can improve productivity within facilities. Due to its toxicity, when hydrogen peroxide is in use, some sites mandate that a set time period must elapse before re-entry to the space is permitted.

This can be based upon calculations around room volume, air changes per hour (HVAC system effectiveness), whether it was fogging, vaporised hydrogen peroxide (VHP), or manual wipe, plus considerations for temperature and humidity.

In the case of VHP bio-decontamination in pharma cleanrooms, the cycle can take 2–6 hours in total, with aeration dominating the time. However, with gas detection installed, it is possible to confidently reduce this time with proven metrics around gas concentrations

22 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Spring 2026 Volume 18 Issue 1

Manufacturing

4.

delivered by gas detection, meaning your facility's uptime and productivity can be improved whilst still maintaining the highest safety standards.

Avoiding Misconceptions and ‘WorkArounds’ Understandably, many organisations approach the topic of gas safety, at least initially, relying, in part, on their existing knowledge of the topic. However, there are many common misconceptions.

A good generic example is hydrogen sulphide. Because of its well-known ‘rotten eggs’ smell, many think that a leak or buildup would be obvious, but this is not the case.

Above a certain concentration, hydrogen sulphide damages the nasal receptors, making safe detection impossible without proper monitoring technology.

Specific training on gas safety – particularly the gases relevant to your setting or facility – is often an invaluable way of helping to correct these types of misconceptions.

Another key issue to be aware of is that different types of monitoring and detection devices are needed for different settings and applications. For example, a common mistake (or ‘work-around’) is for portable personal gas detection devices to be used instead of a fixed-point detector. Most importantly, they cannot warn an operative when an area is safe to enter (outside of that space) without having to enter the hazardous area in the first place.

Furthermore, their alarms are designed to be heard or seen when worn on the person, so they are not sufficiently loud to warn someone www.international-pharma.com

on the other side of a room, or other large space. And portable monitors are batterypowered, which introduces an opportunity for human error if they are not sufficiently charged, rendering them unsuitable for constant monitoring requirements.

Using fixed gas detection removes the opportunity for human error or risk-taking in situations where, for example, a portable device may have run out of charge, but due to operational or production pressures, the temptation might be to enter an area of risk anyway, on the assumption that it’s only for a short time.

A gas detection device should be easy to use and provide the right functionality for the task.

Top Tips 1. Keep it simple – particularly for smaller settings. A well-chosen gas detection system supported by expert advice from a trusted and knowledgeable provider is often more than enough for lowercomplexity environments.

2. To this end, work with the company supplying the gas detection system to minimise touchpoints so that the diagnostic information and configuration of the transmitter can be read directly from a controller. This allows for a single touchpoint, which is easy to access and can be linked to an alarm which sounds if there is a leak to activate swift evacuation of the building.

3. Ask the company with which you are considering working what experience they have in your industry and make

5.

sure that they can handle the full range of gas safety issues in your business.

Additionally, ensure the company has strong engineering, installation and service and maintenance capabilities to support you through the process and look after your system longer-term.

Consider the total cost of ownership of gas detection and monitoring devices – quality can vary, and it’s important to ask, for example, how long consumable parts such as sensors or batteries should last.

There can be significant differences in the lifespan of such parts, and the frequency with which they may need to be replaced can make the difference between good and poor value in the long term. While there is the added requirement that in the pharmaceutical industry, sensors may need a minimum life span to comply with the Good Manufacturing Practice (GMP), the minimum standards which must be met in production processes.

Be alert to ‘workarounds’ in your organisation. Sometimes, particularly in smaller settings, people can be complacent about gas safety and take matters into their own hands.

Gas detection of airborne hazardous substances is an issue that is attracting growing focus, not least with the increased use of new and more environmentally sustainable practices and materials. Obtaining good advice from trusted partners is an effective way for health and safety professionals to efficiently address gas safety concerns, from the small and simple to the sophisticated and bespoke, ensuring peace of mind for all concerned.

Megan Hine Megan Hine, Safety Gas Detection Systems Lead, Draeger Safety UK is an experienced gas safety practitioner leading Draeger’s work on gas safety systems across the UK and Ireland, focusing on fixed gas detection. With over a decade in the safety sector, she has supported major industrial operators and new market entrants, advising on gas detection, prototype trials, and engineering projects.

Megan is a passionate industrial safety advocate, frequent speaker, InstMC committee member, and advisor to the University of Aberdeen on gas safety.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 23

Manufacturing

Designing a Modern Biomanufacturing Model for Batch-to-Batch Consistency Batch-to-batch consistency is the basis for achieving operational excellence in biologics manufacturing. Delivering reliable quality outcomes across facilities, scales, and production runs fosters trust between contract development and manufacturing organisations (CDMOs) and their clients.

As therapeutic pipelines diversify and launch timelines tighten, the biopharmaceutical industry is demanding a robust operating model that paves the way for predictable manufacturing operations, reliable performance, and consistency in releasing quality batches on time. CDMOs, accelerators that enable biopharmaceutical companies to launch products faster, must integrate the three “S” principles into their operating models to ensure consistency in client partnerships.

Model Framework Design A modern framework begins with establishing integrated infrastructures where data-driven strategies shape facility design and direct bioprocesses. In this model, consistency is engineered into the end-to-end system.

Unified digital environments, manufacturing strategies, and quality systems anchor decision-making in a coherent structure.

Real-time data streams guide aligned process definition, steer capacity planning, and predict corrective and preventive action plans, enabling teams to eliminate sources of variation at the design stage instead of managing them later. This integrated foundation creates an optimised environment in which stable performance emerges naturally from the way the system is built.

From this base arise three cores, standardisation, simplification, and scalability, each strengthening the model’s ability to deliver consistent outcomes in batch production and releases.

Standardisation Equipment and process variation across sites hinders consistency. Differing models, digital interfaces, and documentation templates 24 INTERNATIONAL PHARMACEUTICAL INDUSTRY

complicate validation and regulatory work, lengthen technology‑transfer cycles, and raise compliance risks.

Standardisation eliminates these hassles through digitally inspired tools that streamline and optimise processes across sites.

Electronic manufacturing batch records (eMBRs) are the flagship of the digitaltool approach. By replacing paper‑based MBRs, whose limited visibility, transcription errors, and bottlenecks slow every batch, eMBRs bring together validated templates, standardised recipes, and real‑time data streams across manufacturing, quality, and technology‑transfer systems. They execute processes step-by-step, prevent errors, and automatically log auditable batch records.

Building on this digital foundation, standardised eMBR templates capture every critical parameter, raw material specifications, equipment recipes, sampling plans, and deviation controls, thereby cementing process uniformity. The unified data flow bridges operational silos, ensures cross‑site comparability, and satisfies the ALCOA++ principles and regulatory expectations.

Standardisation also embraces equipment equivalency. Bioreactors, chromatography systems, and buffer units are defined using a single, harmonised specification language.

Validation packages are transferable across sites to reduce requalification. Coupled with eMBRs, this unified mechanism ensures process execution and documentation are consistent from site to site. Because this equipment equivalency and eMBR‑driven consistency provide a unified data system, the same standardised framework can now be applied to documentation and manufacturing workflows across sites.

Standardised documentation accelerates product consistency reviews, while uniform digital templates support equivalency-based regulatory submissions. When identical frameworks govern operations, cross-site validation becomes verification rather than requalification, compressing review cycles.

Simplification With this standardised base established, the

model turns to simplification, removing layers that no longer add value. Excessive manual input, layered procedures, and isolated data environments increase human error and prolong technology transfer timelines.

Simplification removes operational layers and embeds automation through modular process design, unified data systems, and automated verification routines. As a result, redundant steps vanish, operator intervention decreases, and production and quality systems synchronise in real time.

Simplification is also a cultural discipline, driving CDMOs to pursue continuous improvement. Every process undergoes evaluation to remove unnecessary variation and optimise resources. Root-cause analyses are performed using a data-driven, streamlined protocol; deviations are uniformly reported and handled across teams; and workforce effectiveness is flexibly scaled in line with operational dynamics. Building on these simplified processes, standardised dashboards and automated decision pathways reduce training burdens and ensure operators work consistently across shifts and sites.

Scalability After standardisation and simplification, maintaining consistency through scale remains critical. Scaling from pilot to commercial manufacturing introduces process drift: Kinetics, mixing, and controlloop responses shift with reactor size or facility design, often requiring recalibration and revalidation.

Modern scalability relies on plant-to-plant equivalency. Each facility follows identical geometric parameters, control algorithms, Spring 2026 Volume 18 Issue 1

Manufacturing and automation systems, ensuring that scale transitions replicate rather than reinvent processes. Equivalent bioreactors, uniform software, and synchronised data infrastructure preserve process identity regardless of the scale and location.

Plant equivalency expedites technology transfer: Teams avoid retraining, requalification, or recalibration. Unified validation protocols and standardised documentation allow immediate cross-facility comparability.

Horizontal production expansion can be done without introducing new risks. Facilities built to a uniform specification set allow production redistribution with minimal downtime, maintaining continuity throughout the project life cycle.

aligned automation allow teams to maintain process integrity across all facilities. During a campaign experiencing a slight drift in metabolite profiles, engineers can quickly evaluate real-time data against the same control parameters used at every location and adjust conditions without hesitation.

Because the integrated operations platform runs on a standardised control logic, performance stabilises quickly and batch trajectories become predictable, enabling strategic capacity planning that aligns with market supply-demand dynamics.

•

By embedding simplification, standardisation, and scalability, the modern biomanufacturing model generates measurable operational advantages: faster approvals, predictable performance, streamlined workflows, accelerated market entry, and actionable insights.

Measurable Advantages •

•

Accelerated regulatory approvals: When CDMOs operate with unified validation logic and identical documentation structures, regulatory teams can compare evidence across sites without rebuilding the data package each time.

A CDMO preparing to bring a new facility online can rely on its established process templates and validation approach rather than drafting new site-specific files.

Regulators review a consistent dataset rooted in the same digital and process framework, which reduces clarification cycles and speeds the approval path.

Predictable operational performance: Harmonised control strategies and

•

Streamlined processes: Integrated data environments and automated reporting remove the latency that slows cross-functional decisions.

When a deviation emerges, such as an inconsistent sensor response, quality and manufacturing teams can access identical batch records and equipment histories through a single system. Instead of circulating PDFs or reconciling conflicting information, teams coordinate directly within the unified data stream, addressing the deviation faster and maintaining uninterrupted production momentum.

Speed to market: Facility equivalency and standardised documentation across plants turn technology transfer into a replication exercise rather than a redevelopment effort. When a CDMO needs to expand output for a biologic product with rising demand, development teams can move the process to another site that already operates with matching equipment, control logic, and documentation frameworks. Because both sites follow the same digital and procedural blueprint, scale-out activities progress

in parallel with final preparation work, removing traditional delays tied to retraining or requalification.

•

Data-driven insight: Integrated data capture across eMBR, automation, and quality systems builds a continuous dataset that supports predictive analytics. When subtle shifts in cell growth kinetics begin to surface, analytic teams can model historical trends from all facilities and identify emerging patterns before they turn into deviations.

The shared dataset reveals causal relationships that would remain hidden in isolated systems, allowing CDMOs to intervene earlier, amend process parameters, and maintain consistent quality over time.

The modern biomanufacturing model, built on simplification, standardisation, and scalability, enables CDMOs to reproduce outcomes consistently across facilities, products, and scales. Simplification reduces complexity and human error, standardisation ensures uniform processes and equipment behaviour, and scalability preserves process integrity.

Together, these principles drive batchto-batch consistency in operations. Realtime data, integrated digital environments, and uniform operations allow CDMOs to prevent variation before it occurs. The result: reproducible performance, faster approvals, reliable supply continuity, and operational excellence – measurable advantages in a dynamic global biologics landscape.

Jaeyun Kim Jaeyun Kim is a senior director of drug substance manufacturing at Samsung Biologics. With more than 15 years of experience in the biomanufacturing industry, Kim oversees GMP manufacturing, directs technology transfer projects for global clients, and drives digital transformation and automation campaigns. He has guided multidisciplinary teams of engineers and scientists to complete holistic transfer and validation processes for a plant with 180,000 L capacity, on expedited timelines that exceed industry standards.

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INTERNATIONAL PHARMACEUTICAL INDUSTRY 25

Manufacturing

Certified ABS Plastics from Bio-Circular and Chemical Recycled Sources Instead of Fossil Ones ABS (Acrylonitrile Butadiene Styrene co-polymer) is an engineering plastics material which is often used in medical devices applications. The reason resides in its relevant properties like processability, impact resistance, surface appearance or dimensional stability among others. For medical applications, specific ISO10993 biocompatible grades are also available, fulfilling with regulatory compliance while maintaining all advantages of ABS properties, like sterilisation and good chemical resistance.

Most plastics normally derive from petroleum as many other materials, like rubbers, synthetic fibers, resins, paints, coatings, adhesives, dyes, detergents, pesticides etc.. Petroleum is a non-renewable fossil resource that was formed over millions of years through the decomposition of prehistoric plants and animals under high temperature and pressure conditions. From the environmental sustainability perspective, the extraction and use of fossil oils is a relevant cause of global warming (due to the related CO2 emissions) and depletion of fossil reserves.

The good news is that plastics do not need to be necessarily produced starting from petroleum, because nowadays biocircular feedstocks and chemical recycled feedstocks are already proven alternatives.

Most important, the recycling technologies that promote the use of such feedstocks are being progressively scaled up. This means, it is possible to continue relying on plastics properties advantages while moving away from fossil raw materials and heading towards sustainable alternatives. The mass balance approach enables this transition, preserving the already existing polymers supply chains while pushing the shift. In this article we will discuss how this is possible mentioning the specific case of ABS plastics. In fact, leading ABS manufacturers are already implementing the two types of sustainable feedstocks previously mentioned.

The petrochemical cracker is a pivotal point for many plastics supply chains. This is an effective stage where the substitutions from fossil-to-bio-circular and from fossil-to26 INTERNATIONAL PHARMACEUTICAL INDUSTRY

chemical-recycled feedstocks can take place.

Crackers are generally designed to process naphtha, which is normally obtained by refining and pretreating crude fossil oil. Nowadays, also bio-circular oils and pyrolisis oils (from chemical recycled waste) can be efficiently refined through methods like hydrotreating and fractional distillation. Once pre-treated, these sustainable oils can be used to feed the cracker, substituting fossil with sustainable naphtha (e.g. bio-naphtha). This input raw material for the cracker is a blend of saturated hydrocarbon chains, containing between 5 and 12 carbon atoms (C5–C12). Such chains need to be broken down by the cracker into smaller and often unsaturated hydrocarbons, producing primary basic molecules that are used in huge quantities in multiple supply chain industries. Approximately 90% of all worldwide plastics production is based on this reduced group of basic molecules. These are: olefins (e.g. ethylene, propylene, butadiene) and aromatics (benzene, toluene, xylene). As consequence, the choice of the cracker as input point of sustainable feedstocks offers huge economy of scales. Hundreds of millions of tons of volumes are produced, feeding different key polymers supply chains.

Let’s consider the cracking process for the specific supply chain of ABS material. The primary basic output molecules of interest for ABS coming from the cracker are: ethylene, propylene, butadiene and benzene.1 The molecules ethylene and benzene are needed to produce ethylbenzene and in a second step styrene, which is one of the three ABS input monomers for the polymerisation process. Butadiene, second input monomer, is needed to polymerise into polybutadiene (the rubber phase contained in ABS, which provides impact resistance properties). Propylene reacts with ammonia (this one obtained from natural gas) to produce acrylonitrile, the third ABS input monomer, and to polymerise with styrene into SAN. SAN (Styrene-Acrylonitrile co-polymer) is the matrix phase of ABS, which provides chemical resistance and stiffness properties to the material. Polybutadiene, chemically grafted with Styrene and Acrylonitrile is already an ABS polymer, with high rubber content. This phase is dispersed in the SAN matrix, completing the ABS polymer formulation.

As can be noticed in the Plastics Europe flowchart,1 all the previously mentioned molecules are traditionally obtained from fossil sources (including ammonia from natural gas). The important message is that, nowadays, they can be obtained also from sustainable sources like bio-circular feedstocks or chemical recycled ones. With the mass balance approach, the downstream supply chains do not need to physically segregate in their process the certified sustainable feedstocks from fossil feedstocks.

In other words, the production process does not need to be doubled in two identical parallel processes, one for the sustainable certified product and one for the fossil-related product. If this would happen, huge additional investments in the chemical industries would be required, making the sustainable shift impossible from an economic perspective.

On the other side, from a chemical point of view, ethylene, butadiene and benzene are identical to the ones obtained from naphtha oil (same chemical CAS number) and they come out from the same petrochemical plant: the cracker.

The second or third level chemical molecules (in terms of supply chain steps) mentioned before, such as ethylbenzene, or the ABS input monomers styrene or acrylonitrile, need specific chemical plant processes to be produced. Such processes can remain identical even if, upstream of the supply chain, the type of input feedstocks in the cracker are partially changed from fossil naphtha to bio-circular hydrogenated used cooking oil or to pyrolysis oil from chemical recycled waste. This represents the highest warranty in terms of product purity and quality for the outputs of each step of the industrial supply chain, as they become the input raw materials needed in the following step downstream. On the other hand, it is important to introduce a traceability system, like the ISCC+ certification with a mass balance approach. This ensures from one side the link with the new emerging advanced recycling supply chains and from the other side the progressive reduction of crude oil and natural gas extraction activities. Upstream in the supply chain, refined bio-circular feedstocks and/or chemical recycled pyrolisis oils will have been employed instead of fossil naphtha to Spring 2026 Volume 18 Issue 1

Manufacturing that can be ISCC certified to reintroduce it to the existing value chains. Also individual households can bring used cooking oils to authorized certified collecting points.

Once collected, used cooking oils can be hydrotreated by a major petrochemical and refining technology company, converting them into a new type of oil (HVO or Hydrotreated Vegetable Oil). Such oil can be further processed to obtain bio-naphtha, that can substitute naphtha oil as input material of the petrochemical cracker. In this way, with a mass balance approach, it is possible to combine naphtha feedstocks, which is obtained from petroleum, with bio-naphtha feedstocks, that are obtained from used cooking oils, and from other biocircular sources like vegetable oils or crude tall oils.

It is important here to make a distinction between first and second generation of HVOs. First generation refers to vegetable oils obtained from land cultivations and are in direct competition with food crops.

On the other hand, the second generation of HVOs (also called 2G) are obtained from waste organic feedstocks like used cooking oil, without competing with food crops, saving land use. In addition, since they are a waste, they are removed from the environment as such (preventing potential negative impacts) and are converted into a sustainable feedstock alternative for the petrochemical cracker, substituting fossil naphtha.

feed the cracker. Such a big switch cannot take place at once, and this is the reason why it must be progressive but growing.

Legislators should take a clear position to promote such an important change to make it economically feasible from two perspectives: the existing chemical supply chain industry, which needs to be preserved, and the emerging recycling supply chain industry, which needs to be scaled up with huge investments.

Let’s see an example of how bio-based feedstocks are already introduced in the ABS supply chain. There are existing grades like ELIX ABS E-LOOP M203FC CR100 (where M203FC means ABS medical grades for medical device applications requiring biocompatibility pretesting according to ISO 10993; E-LOOP means sustainable ABS grade; CR indicates the www.international-pharma.com

ISCC+ Certified Raw materials content, and 100 is the percentage of certified content, which is in this case 100%). The sustainable content is related to the input raw materials used to produce ABS (the ABS monomers). If all the three input ABS monomers are purchased by the ISCC+ certified ABS manufacturer with 100% bio-circular certified sustainable origin, the resulting ABS polymer can be 100% bio-circular ISCC+ certified with a mass balance approach. That’s why in the case of E-LOOP CR100 bio-circular, the assigned input raw materials are Styrene and Butadiene monomers with 100% ISCC+ certified origin from Used Cooking Oil (bio-circular raw material certified category).

As first step, used cooking Oils (UCOs), generated for example in restaurants (“Point of Origin”), are collected by collecting points

As mentioned before, to produce ABS plastics, three input monomers are needed.

We mentioned that Styrene and Butadiene have 100% ISCC+ certified bio-circular origin from Used Cooking Oil. A 100% bio-circular certified origin can be assured also for the third input monomer, Acrylonitrile. This monomer is produced starting from ammonia and propylene.1 Biogas can substitute natural gas to produce sustainable ammonia. Biogas is a renewable source obtained from bacteria when they break down organic waste, such as manure (animal feces), sewage and food scraps.

Forestal / agricultural waste (instead of fossil crude oil) can be used as input raw material for propylene production. This is the feedstock used to produce crude tall oil (CTO), a residue from the pulp and paper industry. It is obtained as by-product of the kraft paper production process, when pulping coniferous trees. Crude Tall Oil can be hydrotreated to produce second generation HVOs (similarly INTERNATIONAL PHARMACEUTICAL INDUSTRY 27

Manufacturing companies (the denomination referring to petroleum will hopefully need to be changed in a next future) and last but not least the advanced recyclers of bio and synthetic waste.

With time, the progressive demand increase for sustainable feedstocks alternatives will lead to no further need for fossil inputs.

This will result in important support for the investments of advanced recyclers of bio and synthetic waste to reach synergic economy of scale. A long-term target for the mass balance approach: not just a coexistence of sustainable sources with fossil ones, but the exclusion of the latter and the exclusive use of sustainable alternatives for the existing polymers supply chains.

REFERENCES 1.

to what we mentioned in the case of cooking oils). Again, the resulting HVO undergo a distillation process producing bio-naphtha among other products (e.g. bio-propane, HVO diesel, Bio-jet, heavy fractions). Bionaphtha can be used as input raw material for the cracker, which will produce propylene as output (among the other basic primary molecules, as mentioned before).

Bio-based feedstocks, particularly those coming from waste (2G HVOs), are not enough to substitute the amount of fossil resources needed annually by the crackers as input materials. For this reason, chemically recycled waste is also needed, and pyrolysis oils production should be scaled up.

There are several types of plastics wastes that can be transformed into pyrolysis oils, like mixed plastic waste or used rubber tires.

The more the waste flows are segregated, the more efficient the chemical recycling process is, providing more output in terms of tons of pyrolysis oils with less energy needed and less environmental emissions. From one side it is crucial to remove plastics wastes from the environment, but it is also important to find ways to avoid incineration processes, due to the high associated CO2 emissions (even in 28 INTERNATIONAL PHARMACEUTICAL INDUSTRY

(please check the Plastics Europe flow chart at this link, which helps to understand the actual supply chains of each type of plastics: https:// plasticseurope.org/sustainability/circularity/lifecycle-thinking/eco-profiles-set/. By clicking on the “ABS” blue box, the conventional ABS supply chain is filtered from the other traditional plastics supply streams). The purpose of the Plastics Europe flow chart is the calculation of the eco-profiles for determining environmental impacts of plastics, in this article we refer more particularly to this chart as general map to understand the actual basic organisation of the plastic supply chains industries.

the case where part of the energy produced can be recovered).

Nowadays the total amount of pre-treated pyrolysis oils (from chemical recycling) and bio-naphtha oils (from bio-circular feedstocks) used as input raw materials for the cracker is still very low and needs to be combined with fossil naphtha oils. This is a critical point, and reason of some misinterpretation of the mass balance concept, which should instead be adopted to make the sustainable transition feasible. In fact, it enables the use of the already existing product supply chains, which is what makes this approach so effective. It supports the progressive reduction of use of fossil feedstocks (something that is urgent but impossible to eliminate at once) and opens the door to the needed investments of the recycling supply chain, that can introduce biocircular and chemical recycled feedstocks into the loop.

The key factor of success to reduce fossil oils and introduce sustainable oils is the joint cooperation work of the companies that are composing the entire supply chains, from final OEMs to part molder converters, polymer manufacturers, monomers, intermediate molecules chemical producers, petrochemical

Luca Chiochia Luca joined ELIX Polymers in February 2017 as Business Development Manager for Healthcare and Consumer sectors, focusing on identifying and developing new markets, products, and applications.

He graduated in Management Engineering from Politecnico di Milano and has over 20 years’ experience in thermoplastics, thermosets, composites, electrical insulation, and electronics. Since 2020 he has been actively involved in the development of ELIX E-LOOP sustainable solutions, including a new growing sustainable ABS blends portfolio, with chemically recycled, bio-circular and mechanically recycled content. Luca wrote several technical articles on behalf of ELIX about specialties and sustainable ABS for medical applications that were published on several renowned medical and pharmaceutical magazines.

Spring 2026 Volume 18 Issue 1

www.international-pharma.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 29

Interpack Subsection

Always the Best Coating: Tablet Coating Engineering for Uniformity, Flexibility, and Resource Efficiency Tablets remain the dominant oral dosage form because they combine accurate dosing, very high stability and acceptance, and cost-efficient, high-throughput manufacturing. Tablet coating or film coating further expands this platform by adding functional performance (e.g., enteric protection, modified release), stability (light/moisture barrier), and patientcentric attributes (taste masking, smoother swallowing, visual identification).

Why Coating Uniformity Matters (and What It Is Not) As coating functions become more complex, e.g., multi-layer systems, combination products, or individualised dosing concepts, uniformity becomes a critical quality requirement. Variations in coating thickness can translate into variability in release, taste masking, or barrier performance; QbD-based approaches (Quality-by-design) have been shown to improve coating uniformity using structured experimentation and analytics.

Uniformity is commonly quantified as RSD (relative standard deviation) of coating thickness or coating mass. Importantly, colour difference (ΔE) is not equivalent to coating uniformity; ΔE indicates perceptible colour differences and should not be used as a substitute for thickness/mass uniformity.

High ΔE values describe a noticeable colour difference.

The Optimal Process: Mixing, Spraying, and Drying Simultaneously Modern drum coating is essentially the controlled coupling of three sub-processes: Mixing / Tablet Motion: It is essential that the tablet cores move smoothly and gently under the spray cones.

The cores must not be subjected to excessive mechanical stress to prevent damage.

For over 20 years, L.B. Bohle (Ennigerloh, Germany) has used an enlarged coating drum with welded-in mixing spirals (length/ diameter ratio >1) to great success. These spirals ensure continuous and gentle mixing of the tablet bed. Homogeneous mixing is achieved within minutes and maintained 30 INTERNATIONAL PHARMACEUTICAL INDUSTRY

throughout the process. The flat tablet bed reduces mechanical stress. Due to the continuous guidance of the mixing spirals, the tablets are not subject to strong acceleration.

Consequently, tablet breakage and twinning are prevented.

Spraying: The geometry of the optimal drum in a tablet coater creates a large spray area within the moving tablet bed. This enables the use of more spray nozzles than would be possible with shorter drums, resulting in a larger total spray area and a higher spray rate. As well as the coating suspension, the type of nozzle, the number of nozzles, and the distance between them are particularly important factors.

Several solutions for adjusting the distance between the nozzles are available, e.g. the spray angle and the atomisation pressure.

Typically, the amount of suspension mass in film-coated tablets is 5–15% of the core mass. Film thickness is particularly important, not only for active ingredient coatings, but also for thin colour (protective) coatings, as it must be uniform. Uneven film application within a batch can result in colour variations that degrade product quality or lead to poor compliance.

weight gain, but recent research emphasises that coating thickness and density can be more physically meaningful attributes for predicting performance (e.g., hydration/ dissolution behaviour) than weight gain alone – highlighting the value of deeper process understanding and suitable analytics. In development and scale-up, PAT concepts (e.g., spectroscopic and imaging approaches) support faster learning cycles and more reliable control strategies.

Equipment Design as a Lever for Speed, Flexibility, and Efficiency While formulation and operating parameters are central, coater geometry and air handling can significantly expand the feasible operating window. As previously mentioned, tablet coaters with an enlarged drum improve both the coating process and efficiency. The larger drum has a larger spray area. A larger effective spray area enables the use of more nozzles and higher total spray rates, which can shorten process times versus conventional short-drum designs. So, process-time reductions up to ~40% for its extended-drum concept compared with short-drum coaters (L/D < 1) can be realised, attributed to higher spray rates and expanded spray area.

Compared to conventional tablet coaters with L/D ratios of less than 1, systems with enlarged drums allow process times to be up to 40% shorter due to higher spray rates.

To reduce spray loss and variability, it is important to direct process air into the tablet bed to improve heat and mass transfer, while avoiding direct impingement on the spray nozzles. This will help to minimise spray drying and related waste.

Drying: Optimal energy and mass transfer are critical.

This means the energy must be applied directly to the tablet bed. Air flows directly and gently into the tablet bed, ensuring rapid drying of the sprayed suspension. The coater periphery and housing are not heated.

Process Control, Energy-Efficient Drying, and Reproducible Cleaning for Higher Plant Availability L.B. Bohle's large-scale production tablet coaters have established themselves in the market and are recognised as technologically advanced.

Optimal airflow creates a smooth spray pattern, reducing spray drying. Spray nozzles are not hit by the supply air stream and remain cool during spraying. This minimises the effects of spray drying and a coating uniformity of >97% or better can be achieved.

Digitalisation and automation are becoming increasingly important in daily production. Against this backdrop, the importance of modern, digitally supported plant concepts is growing. An optimised control system that visualises the process, such as iFix, can contribute significantly to this. Convenient monitoring, structured alarm and trend management, and consistent display of process-relevant variables make

Measuring What Matters: Beyond Weight Gain In practice, coating amount is often tracked by

Spring 2026 Volume 18 Issue 1

Interpack Subsection

operation less prone to error. Deviations are detected earlier, and corrective measures can be implemented more effectively. This is particularly relevant in practice because tablet coating is usually carried out within a narrow operating window, where overwetting (e.g. tablet twinning) and overdrying (e.g. spray drying, rough films and lower transfer efficiency) can directly affect product quality.

Another key factor in achieving quality and cost-effectiveness is the flexibility of drum loading. A system that can handle fill levels between 10% and 100% can accommodate a wide variety of scenarios. However, one should always question why a large-scale production coater would only be loaded to a tenth of its capacity.

In addition, the ability to empty completely, quickly and gently is an underestimated factor in terms of quality and efficiency. Mechanisms such as reverse rotation, integrated mixing spirals and a tiltable design support rapid product discharge with minimal mechanical stress. This reduces residual quantities and shortens cleaning times, improving reproducibility between campaigns, particularly in multi-product environments www.international-pharma.com

where short changeover times and defined cleaning limits are crucial.

Cleaning is often the main factor limiting overall equipment effectiveness (OEE).

Optimised, fully automated cleaning with shorter cycles addresses this bottleneck precisely by reducing downtime, improving cleaning reproducibility, and minimising the need for manual intervention. This has two immediate effects: Firstly, plant availability increases while product quality remains the same. Secondly, the risk of operator error is reduced because cleaning steps are standardised and traceable. Meanwhile, sustainability and energy efficiency are becoming increasingly important: integrated energy monitoring provides transparency regarding the energy requirements of individual process phases, and optional heat recovery in the process airflow reduces the energy input required for drying. This means lower operating costs and a better balance sheet in terms of CO₂ reduction for companies, without compromising drying performance or process stability.

The role of tablet coating has evolved from an aesthetic finishing step to a critical unit operation that can affect product

performance, stability and patient acceptance.

As formulations become more functional, incorporating multi-layer architectures, combination products and tailored release profiles, the ability to deliver robust coating uniformity becomes essential. This requires a holistic view of the process, as uniformity is governed not by a single parameter, but by the tightly coupled interaction of mixing, spraying and drying, supported by analytics that accurately reflect coating quality.

Tobias Borgers Tobias Borgers is a Marketing Professional, with a huge experience of multi -channel marketing initiatives. Proven abilities in creating successful exhibitions, integrated digital and traditional marketing campaigns, social media marketing, content management, lead generation, event and project management. Tobias holds a B.A. from University of DuisburgEssen and joined L.B. Bohle in 2012.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 31

Application Note

Aseptic Robot-Based Radiopharmaceutical Filling For the production and filling of highly effective radiopharmaceuticals, a sterile environment is crucial, and exposing staff to radioactive substances must be avoided. Given these requirements, 100% automation is essential. C-Ray, a leading manufacturer in this innovative field of pharmaceuticals, uses fully isolated production lines from Truking Technology. In these lines, Stäubli sixaxis Stericlean robots safely handle vials during filling, inspection and packaging processes.

Administered locally, with minimal impact on the human body: This delivery method is becoming increasingly popular in the fight against many diseases, including numerous types of cancer – with promising results.

Local or targeted delivery is already used in treatments such as cytostatic drugs and certain forms of radiation therapy. Instead of directing external radiation at the body, radiopharmaceuticals are injected locally at the tumour site, which is much less stressful for the patient.

A New and Successful Type of Cancer Treatment Radiopharmaceutical therapy is a rapidly advancing field, and C-Ray Therapeutics is among the companies leading this development in China. The company’s R&D activities are centred in Shanghai, while C-Ray Chengdu serves as its manufacturing backbone, supporting end-to-end production of innovative radiopharmaceuticals.

At the Chengdu site, C-Ray operates a modern facility equipped with fully isolated automated production lines developed by Truking Technology Ltd. These lines enable the precise aseptic filling, inspection, and packaging of radiopharmaceuticals – capabilities essential for safe and reliable production. To meet growing demand, C-Ray Chengdu continues to expand its capacity, with additional lines scheduled for installation in 2026.

Fully Automated Filling and Packaging of Radiopharmaceuticals The production line supplied by Truking consists of several chambers, which are 32 INTERNATIONAL PHARMACEUTICAL INDUSTRY

isolated from the environment for two reasons: first, due to the strict hygienic conditions. The treatment and handling of medicinal products requires, in this case, a cGMP Grade A aseptic environment. The second reason is equally obvious: radiation protection. Radioactive substances must not escape the production cells.

This is why the radiopharmaceuticals are transferred into the fully automated production line through a controlled transfer chamber. Under stable process conditions, the system operates in a modular configuration, supporting automated drug production.

Robot-Based Transportation Under Aseptic Conditions In each cell, a Stäubli six-axis TX2-60 Stericlean robot performs aseptic filling of radiopharmaceuticals into vials. The robot then transports the filled vials to a real-time radioactivity measurement station.

In the next process step, the robot presents the vials to a visual inspection system. Finally, the vials are placed on slotted trays, ready for automatic labelling. Packaging is also automated, ensuring efficient product dispatch.

A Robot Designed for Critical Applications in Pharmaceutical Production Why did the Truking engineers select the Stäubli TX2 Stericlean for this demanding application? There is more than one reason.

One important point is their ability to work in sterile pharmaceutical environments. The Stericlean designation means the robots can work under aseptic conditions, which includes being cleaned with detergents used in medical and pharmaceutical applications.

Designed to withstand vaporised hydrogen peroxide (VHP) sterilisation, these robots operate reliably in GMP Grade A cleanrooms, meeting the stringent aseptic requirements of radiopharmaceutical production.

Long Life with Continuously High Performance Like all Stäubli robots, the Stericlean range is easily adaptable to diverse production processes, with quick changeover capabilities that enhance operational efficiency. The robots’ longevity also makes them a sound

long-term investment. Over their complete lifespan, the TX2 six-axis robots excel with precise, consistent movement, safeguarding product quality throughout production cycles. Their high performance optimises throughput and overall manufacturing efficiency. This is especially true for the life sciences sector: Leading pharmaceutical companies worldwide trust Stäubli robots, which have a proven track record across global installations.

These qualities are beneficial in all pharmaceutical applications. In the case of the Truking system used by C-Ray, the wallmounted installation option (not available with many robots) is of particular value because space is constrained by cleanroom conditions. Another key advantage is that the robots minimise human intervention, thus reducing radiation exposure and significantly lowering health risks.

A Perfect Solution for Filling and Handling Radiopharmaceuticals Since the system’s deployment, C-Ray has gained extensive experience with the Truking lines for filling and packaging radiopharmaceuticals—and with the Stäubli Stericlean robots. The facility features a compact and streamlined layout, enabling efficient, high-quality radiopharmaceutical production.

The production lines are built on worldclass design principles and leverage intelligent technologies to address key challenges in radiopharmaceutical production. By integrating specialised solutions such as the Stäubli robots, automated visual inspection, and online labelling systems, the facility achieves true end-to-end automation, which is crucial when handling radioactive drugs.

Occupational exposure risks are minimised for technical and operational personnel, and the lines run smoothly with high productivity and reliability.

Further, the Truking production lines fully comply with China’s GMP standards as well as US and EU cGMP regulations. And thanks to their flexibility and control system, the robots support a wide range of supply needs, from R&D and clinical samples to commercialscale batches. Strengths like these make it Summer Spring 2025 2026 Volume 17 18 Issue 2 1

Application Note clear why C-Ray is already planning additional installations at its radiopharmaceutical factory in Chengdu.

Radiopharmaceuticals: A demanding and very efficient class of drugs Radiopharmaceuticals are a specialised class of medicinal products in which radioactive isotopes are incorporated into biologically active compounds or simple molecules.

These compounds utilise the characteristic emissions of different radionuclides for imaging and targeted therapy, supporting both diagnosis and treatment. Widely used in nuclear medicine, radiopharmaceuticals play a vital role in precision diagnostics and targeted therapies, including oncology.

C-Ray Chengdu: Powering the next generation of radiopharmaceuticals C-Ray Therapeutics Chengdu is a key driver in the global radiopharmaceutical ecosystem, combining large-scale infrastructure, broad isotope access, and a proven record of project execution. The 28,000 m² facility houses 13 cGMP suites and operates under a Class A radiation-use license, enabling commercialscale handling of over 30 isotopes.

The site integrates full in-house R&D, from process development and analytical capabilities to a GLP-like preclinical centre, allowing seamless support from early discovery to clinical supply. C-Ray is especially recognised for its leadership in Actinium-225, having secured stable isotope resources and supported numerous next-generation Targeted Alpha Therapy programmes.

With more than 60 successful CRDMO projects, including multiple programs advancing into clinical trials, C-Ray Chengdu serves not only as a manufacturer but as a strategic partner powering the development of innovative radiopharmaceuticals worldwide.

Truking: A leading specialist for aseptic filling of pharmaceuticals Truking Technology Ltd is currently the leading Chinese manufacturer of aseptic filling and freeze drying (lyo) equipment, as well as the leading supplier of inspection systems, secondary packaging machinery, water treatment systems, sterilisation solutions and auxiliary equipment. The company has a strong reputation in the international market.

As of November 30, 2025, Truking has filed 6,465 Chinese patent applications, with 5,350 patents granted and 3,071 valid patents. In addition, it has filed 69 PCT international www.international-pharma.com

On the Truking production lines, radiopharmaceuticals are filled into vials, inspected, and packed under aseptic conditions and isolated due to the risk of radiation exposure.

A wall-mounted Stäubli TX2-60 performs aseptic filling of radiopharmaceuticals.

patent applications and obtained 34 patent authorisations in multiple countries including the United States, Russia, India, South Korea, Germany, Indonesia, Japan and Europe. In 2017, Truking purchased Romaco Holding GmbH, a renowned multi-field manufacturer of packaging and processing equipment for the pharmaceutical industry in Western Europe. This acquisition made Truking one of the largest manufacturers of pharmaceutical systems worldwide.

Space in the cells is confined due to the sterile conditions.

The filled vials are placed in slotted trays.

About Stäubli Stäubli is a global industrial and mechatronic solution provider with four dedicated Divisions: Electrical Connectors, Fluid Connectors, Robotics and Textile, serving customers who aim to increase their productivity in many industrial sectors. Stäubli currently operates in 28 countries, with agents in 50 countries on four continents. Its global workforce of 6,000 shares a commitment to partnering with customers in nearly every industry to provide comprehensive solutions with long-term support. Originally founded in 1892 as a small workshop in Horgen/ Zurich, Switzerland, today Stäubli is an international Group headquartered in Pfäffikon, Switzerland.

Web: www.staubli.com/global/en/home.html

INTERNATIONAL PHARMACEUTICAL INDUSTRY 33

Interpack Subsection

From Impossible to Circular: Unlocking Recycling Pathways for Pharmaceutical Packaging The pharmaceutical and healthcare packaging sector has reached a defining moment. Packaging formats such as blister packs, bottles, tubes, pouches, sachets, cartons and protective wraps are indispensable for ensuring sterility, dose accuracy and patient safety. Yet, once used, the overwhelming majority of this packaging follows a linear trajectory towards disposal or destruction.

This linearity now stands in direct conflict with regulatory, environmental and societal expectations. Under the EU Green Deal, pharmaceutical packaging is no longer viewed as an exceptional category insulated from sustainability obligations. Instead, it is increasingly scrutinised as part of the broader packaging waste system – subject to Extended Producer Responsibility (EPR), recycled content expectations, and netzero healthcare ambitions.

Despite this shift, recycling rates remain alarmingly low. Estimates suggest that only around 14% of blister packs - enter any form of dedicated recycling stream.1 For many other primary and secondary pharmaceutical packaging formats, effective recycling pathways barely exist. Most materials are still incinerated or landfilled, often by regulatory default rather than by design.

The question facing the industry is no longer whether pharmaceutical packaging must become circular, but how this can be achieved without compromising safety, compliance or performance.

Why Pharmaceutical Packaging Has Been Left Behind Pharmaceutical packaging sits at the intersection of some of the most complex requirements in the packaging world.

This starts with material complexity. Blister packs combine aluminium with multi-layer polymers. Tubes and pouches rely on laminated structures, adhesives and barrier layers. Bottles, closures and dispensers may incorporate pigments, additives and functional components to meet regulatory and performance standards.

34 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Second, there is contamination risk.

Packaging that has come into contact with active pharmaceutical ingredients (APIs) cannot be treated in the same way as consumer packaging waste. Conventional mechanical recycling processes are not designed to guarantee the level of decontamination required for highvalue or regulated reuse.

Third, regulatory conservatism plays a role.

Once a packaging format has been validated and approved, change is costly and timeconsuming. This has historically favoured proven linear materials over innovative circular solutions.

These constraints help explain why pharmaceutical packaging has remained largely outside mainstream recycling systems.

However, they do not justify inaction or the lack of development of innovative processes – particularly in light of evolving EU policy.

PPWR and the End of “De Facto Exemptions” The EU Packaging and Packaging Waste Regulation (PPWR) represents a fundamental shift in how packaging is regulated. Unlike previous directives, PPWR introduces harmonised, binding requirements across Member States, with a strong emphasis on waste reduction, recyclability and recycled content.

Crucially for pharmaceuticals, PPWR signals the end of implicit exemptions based on complexity or safety concerns.

While certain medical and pharmaceutical packaging will require exemptions many more could become much more sustainable and the overall direction is clear: most packaging must be designed for circularity, and producers must take responsibility for its end of life.

Under PPWR, claims of “non-recyclability” will increasingly require justification. The burden is shifting from regulators asking whether recycling is possible, to producers demonstrating why it is not.

This regulatory reality demands new thinking – not just about packaging design, but about the new systems that will support collection, sorting, decontamination and recycling.

Extended Producer Responsibility: From Cost to Catalyst Extended Producer Responsibility has historically been viewed by many pharmaceutical companies as a compliance cost rather than a strategic lever. That perception is rapidly changing.

As EPR schemes evolve, fees are increasingly modulated based on recyclability, recycled content and environmental performance.

Packaging that lacks viable recycling pathways is likely to attract higher costs, greater scrutiny and reputational risk.

Conversely, packaging formats that are supported by credible, scalable recycling systems can benefit from lower fees, regulatory confidence and long-term material security.

EPR therefore has the potential to act as a catalyst for innovation, encouraging pharmaceutical companies to invest collectively in infrastructure and technologies that unlock circularity – rather than bearing escalating costs for linear solutions.

Learning from “Impossible” Materials Working with some of the world’s most difficultto-recycle materials consistently demonstrates that circularity in primarily a materials challenge – it is a systems challenge. Flexible food packaging, cosmetic packaging and highperformance medical plastics share many of the same challenges as pharmaceutical packaging: multi-material construction, contamination risk and demanding end-quality requirements.

Traditional recycling systems were designed for conventional waste streams. Pharmaceutical packaging does not fit this model and never will.

Expecting it to conform to municipal recycling norms is neither realistic nor necessary.

Instead, the sector requires bespoke recycling pathways designed specifically to handle complexity, manage contamination and deliver compliant outputs.

Supercritical CO₂: Enabling Pharmaceutical-Grade Recycling One of the most critical barriers to circular pharmaceutical packaging is decontamination.

Without robust, scalable methods to remove chemical residues and absorbed substances, Spring 2026 Volume 18 Issue 1

Interpack Subsection recycled polymers cannot safely re-enter regulated applications.

be purified to a level compatible with circular systems.

Solvent-assisted COtooCLEAN™ technology addresses this challenge directly.

Beyond Blister Packs: A System-Wide Challenge Blister packs are often highlighted as the emblem of pharmaceutical packaging waste but focusing solely on blisters risks overlooking a broader opportunity.

The process uses supercritical carbon dioxide to extract contaminants from polymers at a molecular level. In its supercritical state, CO₂ combines the penetration properties of a gas with the solvating power of a liquid, allowing it to potentially remove APIs, additives, oils and odours without degrading the polymer itself.

Unlike solvent-based or high-temperature processes, COtooCLEAN™ leaves no residual chemicals, preserves polymer performance and has a low carbon footprint. This enables recycled materials to meet demanding quality and safety thresholds – opening the door to high-value, regulated re-use.

For pharmaceutical packaging, this represents a step-change: materials previously deemed unsuitable for recycling can potentially

The pharmaceutical sector generates a diverse stream of plastic and fibre-based packaging, including bottles, tubes, pouches, sachets, cartons and protective films.

Collectively, these materials represent a significant environmental footprint – and a significant opportunity for circularity.

Achieving meaningful progress requires addressing this entire ecosystem, rather than treating each format in isolation.

Redefining Recyclability in a Regulated Context A persistent misconception in sustainability

SusPack: A Blueprint for Circular Healthcare Packaging This systems-led approach underpins SusPack, an Innovate UK-backed collaborative project bringing together Nextek, University of Nottingham and University of Kent through to NPL for materials science and measurement, Sealeo Ltd for packaging solutions, CPI for pilot-scale innovation, Bridge Farm Bioscience Ltd for biotech expertise, The Naked Pharmacy Ltd for pharmaceutical packaging insight, Impact Recycling Ltd and ReVentas Ltd for recycling operations, Alga (Seaweed) Ltd for sustainable biomaterials, and Impact Solutions Ltd for consulting and systems integration.

Collectively, they are developing scalable, compliant recovery pathways for a wide range of pharmaceutical packaging formats.

The project focuses on real-world implementation. Its objectives include: •

Developing advanced sorting and separation processes for complex healthcare packaging

•

Applying supercritical CO₂ decontamination and delamination processes to achieve pharmaceuticalgrade recycled polymers

•

Demonstrating alignment with regulatory and safety requirements

•

Creating replicable models that can support EPR compliance and PPWR objectives

SusPack illustrates how cross-sector collaboration can overcome challenges that no single organisation can solve alone. debates is that packaging must be compatible with household recycling to be considered recyclable. For pharmaceutical packaging, this assumption has been deeply limiting.

Pharmaceutical packaging requires controlled, traceable systems that reflect the sector’s regulatory realities and keep it separate from domestic waste streams.

Such systems already exist in other regulated industries, from medical devices to www.international-pharma.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 35

Interpack Subsection

industrial chemicals. Applying similar thinking to pharmaceutical packaging is both logical and necessary.

Net-Zero Healthcare and Material Responsibility With healthcare accounting for 4–7% of national greenhouse gas emissions in many developed economies, healthcare systems across Europe have committed to ambitious net-zero targets, and pharmaceuticals are a major lever for change.

In the UK, the NHS has committed to netzero for directly controlled emissions by 2040, and for the full supply chain by 2045. EU health systems have aligned with the European Green Deal and Fit for 55, focusing on decarbonising public procurement, medical supply chains and waste.

Packaging, while only one component of healthcare emissions, is a visible and addressable contributor.

Incineration and landfill not only represent a loss of material value but also generate avoidable carbon emissions. Circular packaging systems, by contrast, reduce reliance on virgin polymers and lower lifecycle emissions.

For pharmaceutical companies, investing in circular packaging is therefore not just an environmental imperative, but a strategic contribution to net-zero healthcare goals.

36 INTERNATIONAL PHARMACEUTICAL INDUSTRY

From Incremental Change to Systems Transformation The pharmaceutical industry is rightly riskaware. Patient safety must always come first.

However, safety and sustainability are not mutually exclusive.

The technologies, policy frameworks and collaborative models needed to unlock circular pharmaceutical packaging now exist. What is required is the willingness to move beyond incremental change and embrace systems-level transformation.

A Call to Action The transition from linear to circular pharmaceutical packaging is underway – and it will accelerate under PPWR, EPR reform and netzero commitments.

Pharmaceutical leaders must engage early, collaborate across value chains and invest in solutions that address end-of-life challenges directly.

Packaging designers and sustainability teams must focus not only on design for recyclability, but on creating pathways that function in practice.

Policymakers and regulators must continue to recognise and enable advanced recycling and decontamination technologies that make circularity possible. Materials that protect patient health should not compromise planetary

health. By rethinking how pharmaceutical packaging is recovered, decontaminated and re-used, the industry can move from impossible to circular – and help deliver a genuinely sustainable healthcare system.

REFERENCES 1.

https://pmarketresearch.com/chemi/pharmaceutical-recyclable-blister-packaging-market/

Edward Kosior For over four decades, Edward has been at the forefront of innovation in polymer technology, driving change across recycling ventures and as the visionary Founder and Managing Director of Nextek.

A holder of multiple patents in plastic recycling, he has played a pivotal role in bringing recycled PET, HDPE, and PP into mainstream food packaging across Europe, Asia, Australia and the Americas Beyond packaging, he is deeply committed to tackling plastic pollution in our oceans and championing sciencebased solutions and best practices to address the environmental challenges faced by developing nations.

Spring 2026 Volume 18 Issue 1

Injectables

Annex 1, Sterility Assurance, and the Rising Bar for PUPSIT The latest revision of EU GMP Annex 1 has transformed sterile manufacturing expectations from a primarily reactive, end-of-line mindset into a fully integrated approach to contamination control and sterility assurance. Among the changes drawing the most attention from sterile fill/finish teams is the clarified expectation for pre-use post-sterilisation integrity testing (PUPSIT) of sterilising grade filters.

PUPSIT is now widely viewed by EU regulators as a standard element of a compliant sterile filtration strategy rather than a discretionary add-on. For sponsors targeting EU approval, or planning eventual global expansion that includes Europe, it has become a practical “cost of admission” alongside isolator technology, robust environmental monitoring, and formal contamination control strategies.

time of actual use is a much stronger control than a filter only proven integral after product has already passed through.

regulators the likelihood of masked damage is acceptably low. Such an assessment typically examines:

Regulatory Expectations and When PUPSIT May Be Omitted Annex 1 states that “the integrity of sterilised filter assembly should be verified by integrity testing before use (PUPSIT),” and in regulatory practice this “should” is treated as a default expectation. By contrast, the U.S. FDA has not made PUPSIT mandatory, which means global programmes must reconcile differing expectations when designing a single filtration strategy for multiple markets.

•

For products intended for the EU, omitting PUPSIT requires more than a procedural preference; it demands a robust, documented risk assessment that convinces

• • •

Filter type, manufacturer, and manufacturing method.

Transportation, storage, and sterilisation methods.

Packaging, handling, and inspection procedures.

Product type, including potential for membrane fouling or masking defects.

Where very small batch volumes are at stake, the volume required for filter wetting and testing can consume a significant portion of the batch, making PUPSIT technically or economically challenging. In these situations, a sponsor may pursue a justified alternative strategy, but should expect extensive data requirements and close dialogue with the

What PUPSIT Actually Addresses At its core, PUPSIT is a response to a simple but significant risk: a sterilising filter that appears to pass post-use integrity testing may in fact have been compromised prior to, or during, product filtration. Damage introduced during transport, handling, assembly, or sterilisation can be partially masked by product fouling of the membrane during processing. In these cases, a defective filter can meet post-use integrity limits because the product reduces flow through what is no longer a fully integral membrane.

PUPSIT mitigates that risk by verifying filter integrity after sterilisation but immediately prior to sterile filtration. In practice, operators wet the sterilising filter with a suitable medium – commonly water, buffer, or product, depending on filter design, validation data, and product characteristics – and connect a test instrument to conduct an automated integrity test. Parameters such as pressure, hold time, and acceptable test limits are established during filter and process validation. The outcome is a quantitative integrity readout with a pass/fail result before any product is exposed to the filter.

From a sterility assurance standpoint, this sequencing is critical. An integral filter at the www.international-pharma.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 37

Injectables Qualified Person (QP) and regulators. For many commercial programmes, the cumulative effort and uncertainty of “justifying out” PUPSIT outweighs the effort of designing it in from the outset.

Misconceptions and Practical Challenges Despite its now central place in EU-focused sterile operations, PUPSIT still suffers from several practical misconceptions. One recurring concern is that in situ integrity testing increases the risk to the batch by introducing additional manipulations, connection points, and valves into an otherwise closed sterile system. Another is that PUPSIT will inevitably slow batch release and inflate costs relative to a post-use-only integrity testing approach.

The reality is more nuanced. The test method itself is not intrinsically complex; the complexity arises from executing it in situ on production equipment. Additional connection points, manual interventions, and the requirement to fully and consistently wet filters create operational failure modes that are not present in offline testing. In a large proportion of observed failures, the root cause lies in technique – insufficient wetting, air entrapment, inconsistent methods, or limited understanding of the underlying fluid dynamics – rather than in the filter or the test instrument. These are addressable issues, but they require design attention, operator training, and experience.

Facility and System Design: Building for Annex 1 and PUPSIT One way to reduce the perceived burden of PUPSIT is to treat it as a core design requirement rather than as a retrofit

obligation. When PUPSIT capability is integrated into the initial layout of a sterile fill/finish facility, the design team can optimise equipment configuration, utilities, and automation to support in situ testing without creating unnecessary contamination risks or operational complexity.

A purpose-built large-scale isolatorbased fill/finish facility, for example, can be configured with: •

•

Isolator technology sized for commercial volumes and flexible vial formats, to minimise operator intervention at the critical zone.

Clearly defined routing of utilities

• •

and piping, including the additional connections needed for integrity testing equipment.

Walkable ceilings and external maintenance access to reduce interventions in classified areas over the facility lifecycle.

Redundant clean utilities and equipment to support maintenance and unexpected downtime without compromising ongoing sterility assurance activities.

Such design choices support Annex 1’s emphasis on proactive contamination control and sterility assurance, while providing the necessary infrastructure to deploy PUPSIT as a routine, low-disruption step in the process.

They also allow fill lines – such as high-speed isolated vial fillers handling a broad size range – to be validated with PUPSIT in mind, rather than forcing later compromises to shoehorn additional testing into a fixed layout.

Modular Single-Use Assemblies and PUPSIT Execution Beyond the facility and equipment level, the design of single-use assemblies has a significant impact on how reliably PUPSIT can be executed.

A modular approach – using standardised subassemblies that can be configured for different products, filters, and process steps – offers clear advantages over a proliferation of bespoke, allin-one part numbers.

In a modular architecture, tubing sizes, pre-filters, sterilising filters, flush bags, and integrity test connection points can be combined as needed to meet a specific process requirement without redesigning

38 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Spring 2026 Volume 18 Issue 1

Injectables the entire assembly. If a component proves problematic, it can be replaced without discarding the full build, and the same core components can support a large client base.

For sponsors, this translates into: • • •

Increased flexibility when processes change or scale.

Reduced lead times, as fewer unique part numbers need to be qualified and stocked.

More predictable execution, since operators gain experience on a smaller set of reusable building blocks.

Critically, modular designs can be optimised for PUPSIT from the start. For example, they can include appropriately positioned test ports, pre-filtration options to mitigate air locking during wetting, and drain paths that facilitate efficient flushing of wetting media. The result is not only higher test success rates but also reduced operator burden during aseptic manipulations.

The Role of Operator Expertise and Training No matter how advanced the facility and assembly design, PUPSIT ultimately depends on the people executing it. Inadequate wetting, inconsistent venting of entrapped air, or improper interpretation of integrity test results can all undermine the value of the control.

Organisations that routinely perform PUPSIT across a diverse portfolio of molecules and assemblies develop a body of institutional knowledge that can be difficult to replicate in lower-throughput environments. Experienced operators understand, for instance, when a filter is likely to be difficult to wet and when additional steps – such as using a pre-filter on the wetting agent to reduce air lock, providing sufficient back pressure on the system during wetting, or adjusting the flush volume – are warranted. That experience reduces false failures, helps distinguish between filter and technique issues, and preserves both batch integrity and schedule.

From a sponsor’s perspective, evaluating a partner’s PUPSIT capability therefore extends beyond the presence of test instruments and written procedures. It should include questions about the depth of operator training, the frequency and diversity of PUPSIT execution, how deviations are analysed, and how lessons learned feed back into assembly and process design.

Strategic Considerations for Global Programmes Sponsors that begin their journey in the U.S. www.international-pharma.com

often face a strategic question: implement PUPSIT from early development, or introduce it later when EU expansion comes into view.

While deferring can appear attractive in the short term, it can create friction when scaling up or transferring processes across regions.

Retrofitting PUPSIT into a mature process may require new assemblies, revised process validations, and additional regulatory dialogue.

Building PUPSIT into the development plan from the outset can offer several advantages for globally ambitious programmes: • • •

A single, harmonised filtration strategy that meets EU expectations and is acceptable in other markets.

Reduced need for later revalidation and change control as regional scope expands.

Earlier generation of data linking PUPSIT performance, filter robustness, and product quality outcomes.

In parallel, macro trends such as a renewed emphasis on domestic manufacturing in North America, evolving trade policies, and concerns about supply chain resilience are influencing where and how commercial capacity is deployed. Large, Annex 1-aligned, isolator-based facilities in the U.S. that are equipped for routine PUPSIT therefore occupy a growing role in many sponsors’ long-term supply strategies.

PUPSIT as Part of a Broader Quality-byDesign Mindset Viewed in isolation, PUPSIT can seem like one more discrete compliance box to tick. In the context of modern Annex 1 expectations, however, it is better understood as one component of a broader quality-by-design approach to sterile manufacturing. That approach ties together: •

Facility design that reduces inherent contamination risks and enables robust,

• • •

isolator-based operations.

Single-use assemblies and filtration strategies that anticipate PUPSIT and minimise operational complexity.

Operator training and experience that translate written procedures into consistent practice.

Data-driven risk assessments and validation work that align global regulatory expectations with the practical realities of manufacturing.

When these elements are developed cohesively, PUPSIT shifts from being perceived as a fragile, high-variability step to a predictable, low-risk part of routine batch execution. Rather than undermining confidence in the process, it reinforces sterility assurance by confirming that critical barriers are intact precisely when they are needed most.

Steve Taliadouros Steve Taliadouros, Director MTS, has over 29 years of experience in the pharmaceutical industry across varying roles in operations, plant engineering, and process engineering. He has overseen numerous facility start-ups and expansions. Currently, he serves as the Director of Manufacturing Science & Technology at PCI Pharma Services, where he oversees MTS teams across manufacturing operations, including tech transfers, generation of batch records, process change controls, and process improvement initiatives. Taliadouros has previously held engineering and manufacturing positions at LSNE (acquired by PCI in 2021), Shire, Lonza, and Genzyme.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 39

Injectables

Why You Can’t Design a Prefilled Syringe System Out of Components Over decades, the challenges of drug delivery have continually been met with innovation. Problems have been met with solutions.

Take the prefillable syringe. These devices were first introduced in the Second World War as a mechanism for delivering injections in battlefield settings – an innovative answer to the question of how to administer medication with speed, sterility and dosing accuracy. While the fundamental premise has remained the same, today prefilled syringes have grown in significance and prevalence, with advances in design and materials science ensuring they have a crucial role in the delivery of drugs, including sensitive biologics, through their ability to preserve the drug’s quality, efficacy and safety; deliver highly targeted doses; and support self-administration.

While prefillable syringes might have provided the means to simplify drug delivery, they are part of a highly complex, strongly regulated, and traditionally componentdriven development program. Being regulated as combination products adds an additional layer of complexity. From design and development through part selection, design and development verification and manufacturing, there are many critical, often contradictory considerations that must be taken into account to simultaneously ensure the quality, efficacy and safety of the drug within a safe, functional and usable device.

The success of these development programs is undoubtedly testament to the sector’s problem-solving capabilities, but they also serve to highlight the absence of more efficient ‘top down’, integrated and holistic solutions.

The issue at the heart of the matter is that while prefillable syringes present as systems, they are, in fact, as of now a collection of multiple components combined to form a coherent whole. And given the highly regulated nature of these combination products, it is therefore quite typical for development to be a lengthy and highly complex process. In a market increasingly 40 INTERNATIONAL PHARMACEUTICAL INDUSTRY

populated by emerging biotechnology companies, the process of taking a molecule from formulation to the market as a final combination product can be a daunting one, beset with pressures in a variety of areas.

Currently, these issues are addressed through engagement with external consultancies and a disaggregated network of supply chain partners. The onus is on the drug originator to co-ordinate these moving parts and bring various strands of development together. Indeed, the sourcing and procurement of components demands detailed knowledge of the quality target product profile (QTPP), the critical quality attributes (CQAs) and other information needed to create robust design and development inputs as guided by the Quality Guidelines 8 and 9 of the Internation Council of Harmonization (ICH Q8 and Q9).1 Current Good Manufacturing Practice (cGMP) regulations across global territories, which include Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) and Part 820 (Quality Management System Regulation) of Title 21 of the Code of Federal Regulations in the United States (21 CFR Part 211 & 820) and the GMP guidelines in the European Union (EU GMP).2,3,4 In the very earliest stages of defining the design and development inputs and selecting the according components, pharma and biotech companies looking to develop a prefillable syringe (PFS) system face an almost bewildering array of component choices. And for each component, arriving at an optimal decision will require engagement in a time-consuming and highly detailed sourcing process involving multiple contacts at a broad range of potential supply partners. Typically, this will initially involve stakeholders defining the component specification before conducting market research to identify possible candidate suppliers. Following completion of this phase, requests for information (RFI) will be issued to shortlisted providers as part of an evaluation of production capabilities and to verify quality and compliance credentials.

Risk assessments and supplier qualification checks will also need to be carried out as part of this comprehensive due diligence process, which for each company will need to be conducted under the security of a

Confidential Disclosure Agreement (CDA) to ensure all parties are legally protected.

Indeed, in some cases, there will be a need to establish more complex three-way CDAs to facilitate discussion between multiple partners.

Taken together, all these stages evidently add up to a significant investment in time, energy and therefore cost for sponsors, who are ultimately responsible for oversight of the device. They face clear pressure in managing supplier relationships effectively and mitigating risk in the interests of final drug quality and continuous improvement.

Importantly, this must be considered from first point of engagement through to development, design and development verification and validation testing, clinical and human factor studies, technology transfer and commercial manufacturing, while also exerting control over change management activities and product quality throughout the combination product’s lifecycle. Throughout, the need to align on technical demands must be matched by a shared culture, agreed behaviours and effective communication for this to be achieved with minimal friction.

Record-keeping and data management can present particular challenges in this multi-stakeholder environment. Sponsors are not only required to evaluate distinct device constituent part-level datasets in isolation, but – being a combination product – also to ensure performance of the PFS as a final system. Ultimately, disparate datasets will need to be compiled into a unified and robust Device and Development File (D&D File) as part of the submission as an Electronic Common Technical Document (eCTD).

Practically speaking, this task is far from straightforward. Take, for example, the fact that a rigid needle shield (RNS) will be supplied with product specifications detailing material attributes across a variety of characteristics. This includes measurements such as pull-off force, endotoxin level, bioburden level and particulate matter – which are reported differently throughout the industry, e.g. according to a Proved Clean Index value. The same PFS system will also feature particle data from the glass barrel Spring 2026 Volume 18 Issue 1

Injectables

supplier reported as a specific percentage based on United States PharmacopeiaNational Formulary (USP-NF) <788>.5 Meanwhile, the plunger supplier will report on particulate matter in terms of amount per square centimetre of plunger surface area. This places the onus on the applicant to understand the interplay between three different measures, potentially from three separate suppliers, in order to arrive at a robust singular evaluation of particle characteristics at a system level.

And this is a task that must be repeated for all critical characteristics of the PFS beyond particulates, amounting to a heavy dataevaluation burden.

There are also inherent challenges regarding stakeholder management where multiple vendors are concerned, each with individual stipulations in terms of minimum order quantity options, and with limited guarantees of consistency when it comes to manufacturing processes and, therefore, quality. Moreover, if complaints later arise in relation to the PFS, accountability cannot likely be attributed to a single supplier, requiring the authorisation holder to detangle and resolve potentially difficult interlinked issues.

Assuming they are not ‘show stopping’, such challenges can, of course, be overcome, but resolving them can add layers of complexity and place additional demands on internal resource. If problems escalate, however, there is a real risk of milestones being missed, unforeseen increases in development costs and, potentially, delays to product launch. This might be caused, for example, by the need to retrospectively source specific aspects of performance data, the failure to meet in-clinic targets for quality and/or quantity of supply, or delays to the regulatory approval process.

Delays to a device’s development schedule and launch are well known to have damaging implications. However, translating those www.international-pharma.com

problems into a financial cost has come down to estimates and anecdotal evidence.

But in late 2023, the Tufts Center for the Study of Drug Development grounded this conversation in real-world figures based on empirical research. It concluded that the cost of missing a single day in drug development equates to approximately $500,000 in lost prescription drug or biologic sales. It also puts an approximate price tag of $40,000 per day on phase II and III clinical trials, underlining the financial imperative of avoiding issues that have the potential to extend trial schedules.6 For years, this fragile dynamic has been the status quo in the sourcing of prefillable syringes, driven by a component-based approach to device selection and evidencing of system-level performance. But zooming out to reflect on this situation, it is not unreasonable to question whether drug companies should continue to absorb these pressures as an accepted and unavoidable cost associated with achieving their goal.

In an evolving market, is a one-size-fits-all approach optimal for all innovators? Where it is appropriate for the application in question, would it not be possible instead to bypass the many points of friction involved in building a system from disparate components and instead employ a ready-made system that has already been verified for the task?

Today, those assumptions are being directly challenged by the groundbreaking introduction of integrated PFS systems.

Incorporating pre-verified device constituent parts – syringe barrel, plunger and needle shield/tipcap – these novel systems provide a catalyst for emerging biologic and vaccine innovators to accelerate the journey towards the critical milestone of clinical fill/finish.

They provide the means to accelerate PFS selection, simplify vendor management, secure reliable single-source device supply, and streamline regulatory submissions through a pre-prepared system performance verification data package.

Applying a system-level approach such as this truly has the potential to shift the current paradigm in PFS development. As explored above, the current component-driven model introduces the need for sponsors to manage a multiplicity of risks across a disaggregated network of suppliers, which, cumulatively, can represent a potentially insurmountable task for emerging biotechnology companies that are under pressure to deliver their molecule to clinic and progress towards marketing approval.

As with so many examples of impactful innovation, the premise of taking a systemlevel rather than component-driven approach to PFS development is not reflective of wholesale reinvention or the ripping up a proven playbook. Rather, it is about challenging the status quo, addressing underlying flaws, and creatively rethinking how to optimise the pathway to same destination. It rests on an acknowledgement that where problems remain unsolved, drug delivery’s innovators will keep rising to the challenge of pioneering newer, better, and faster ways of bringing therapeutic benefits to the lives of patients in need.

REFERENCES 1.

2.

3.

4.

5.

6.

ICH Guidance for Industry Q8: Pharmaceutical Development; International Council for Harmonisation (2009); ICH Guidance for Industry Q9: Quality Risk Management; International Council for Harmonisation (2005) https://www.ecfr.gov/current/title-21/ chapter-I/subchapter-C/part-211 https://health.ec.europa.eu/medicinalproducts/eudralex/eudralex-volume-4_en https://www.fda.gov/medical-devices/ quality-system-qs-regulationmedical-devicecurrent-good-manufacturing-practices-cgmp/ quality-management-system-regulation-finalrule-amending-quality-system-regulationfrequently-asked USP <788> Particulate Matter in Injections; United States Pharmacopeia (2013) https://link.springer.com/article/10.1007/ s43441-024-00667-w

Dr. Bettine Boltres Dr. Bettine Boltres,Director Scientific Affairs, Integrated Systems at West Pharmaceutical Services, is a recognised thought leader in the industry, fostering scientific exchange between West and the pharmaceutical sector. She possesses extensive knowledge in glass, polymer, and rubber materials, which carries over in her expertise in combination products. Dr. Boltres is the author of the book “When Glass Meets Pharma” and serves as an expert for the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and various ISO working groups. Additionally, she plays an active role in the Parenteral Drug Association (PDA) and is serving on the PDA Board of Directors since 2019.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 41

Injectables

The Platform Effect:

Elevating Manufacturing Efficiency in Injectable Drug Delivery “At its core, fill-finish involves taking a bulk pharmaceutical product – whether a vaccine, biologic, or small molecule – and precisely filling it into its final container for distribution. For some products, such as biologics, the complexity is amplified due to their sensitive nature. These treatments require highly specialised, sterile environments and precise handling to maintain their potency and safety. The demand for biologics, gene therapies, and cell therapies has rapidly accelerated, and so has the need for innovative solutions in fill-finish packaging and manufacturing.”1 Emma Verkaik, CEO of the BCMPA – The Association for Contract Manufacturing, Packing, Fulfilment & Logistics

In the Summer issue of IPI, Emma Verkaik, CEO of The Association for Contract Manufacturing, Packing, Fulfilment & Logistics, writes, “The fill-finish phase in the pharmaceutical manufacturing industry is undergoing a significant transformation. Once primarily focused on the aseptic filling of vials and syringes, it has now evolved into a multi-faceted process requiring a high degree of technical precision, regulatory awareness and strategic foresight.”1 The need for the integration of final combination device assembly into the production process has heightened the importance of device design to achieve optimal production process efficiency.

Delivery device partners must align with current manufacturing priorities. As the pharmaceutical industry innovates and enables greater self-administration of more complex dosing regimens, it needs appropriate drug delivery solutions, capable of handling a range of formulation types.

Many therapies and their dose regimens can be accommodated by flexible and de-risked platform devices. New drug formulations need ever more flexible solutions – but developers have to square the circle while containing costs, and ensuring performance and ease of use.

Additionally, with patient populations growing, manufacturing efficiency is key for cost effective global market access.

42 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Typical Assembly Scenarios Pharmaceutical manufacturers will be familiar with a scenario where one drug requires six different fill volumes, and two or three different types of autoinjector. In this scenario, the manufacturer modifies assembly processes for each autoinjector, adjusting pre-filled syringe filling and stoppering, for instance.

Each of these variants will require individual assembly process validation steps; this additional validation requirement drives significant operational and quality complexity and therefore costs. Optimised device design reduces the line change requirements between product variants throughout a manufacturing campaign, improving overall capacity utilisation.

Innovative biologic therapies further increase complexity. Batch sizes for these therapeutic products are inherently smaller and more variable, resulting in more frequent changeovers, with filling lines adjusted for each batch. Small batch variations can also impact device performance, specifically injection time and plunger force. Inherently flexible autoinjectors can therefore streamline assembly activities for innovative products in development, and support consistent performance.

Wide Performance Envelope Platform devices with a wide performance envelope are able to function with both low and high-volume drugs, and formulations of varying viscosity, while also accommodating broad user requirements such as lack of

dexterity or needle phobia. As one device engineer puts it, “For pharmaceutical companies, platform devices offer a near ‘offthe-shelf’ solution to deliver their assets”.2 Delivery device manufacturers make the significant upfront investment to create this comprehensive device, which acts as the core product ready to be customised by pharma partners when putting together a combination product.

Given the extended timeline from initial discovery to market approval (often a decade or more ), a robust platform device that flexibly adjusts to drug volumes and viscosities offers some relief to drug developers.3 In one example of a modern platform autoinjector, the device’s plunger rod auto-adjusts to the stopper position regardless of the fill volume, eliminating the need to change parts.

This means that if the required delivery volume or formulation changes (as it often does during drug development), the device design or configuration does not.

The autoinjector’s configuration flexibility allows for a fill volume range of 0.3mL up to 2.25mL from one device. Once assembled, the consistent distance between the stopper and plunger for all dosages reduces the need for individual verification and process validation.

This is an example of an injector design optimised for both patient performance and manufacturing efficiency.

Inclusive and Intuitive Design The initial investment from the device maker entails inclusive design and testing strategies,

Figure 1 Advantages of a new, flexible autoinjector compared to a standard autoinjector Spring 2026 Volume 18 Issue 1

Injectables covering patients with differing physical and cognitive abilities (including some very small patient cohorts). As the specific user group is not known during design, platform devices must accommodate multiple patient groups – from carers administering medication to family members, to self-injecting elderly patients with limited dexterity.

Audible and visual notifications – e.g. audible clicks at the start and end of dose delivery and a clear viewing window – provide reassurance to users, for instance.

Obscuring the needle during injection not only prevents needle exposure but may offer relief to patients with needle phobia. The effectiveness of platform products in meeting diverse needs can make them pivotal to commercial differentiation.

Streamlined, Sustainable and Scalable Manufacturing With a platform product, the manufacturing scenario described above (one drug, six different fill volumes, two-three autoinjectors) is no longer a necessity. Line changes for each batch are simpler. The same lines can be used without modifying machinery like assembly equipment, labelling, blister packing, and uniform carton packaging.

Currently, in many organisations, line availability is reduced as manufacturers handle the numerous product Stock Keeping Units (SKUs) and device combinations needed for diverse dosage forms, along with manufacturing line changeovers.

Optimising resource use, reducing waste, and strengthening efficiency can also help to minimise environmental impact in a sector where sustainability is often complex and even counter-intuitive.

Design-enhanced production efficiency is a prerequisite for effective scaling – a necessity as demand for autoinjectors grows, with populations ageing, incidence of chronic diseases rising, and pressure on healthcare systems deepening. Device manufacturers must therefore have robust scaling strategies in place. Demand and risk management may require supply chain strategies such as dual sourcing. Partnering with suppliers that have a global footprint to combine capabilities and increase manufacturing capacity ensures device makers’ security of supply, allowing them to optimally manage demand.

Customisation Possibilities How might platform devices be customised?

As described above, such devices inherently adapt to different drug delivery requirements, www.international-pharma.com

from fill volumes to user groups, ideally with minimal change parts needed. For higher viscosity formulations, manufacturers may consider customised spring force options – i.e. high drive for high viscosity and/or larger volumes, or low drive for lower viscosity and volumes.

With various syringe and RNS (Rigid Needle Shield) options available in the market, it is convenient if the drug delivery device is designed to accommodate a broad range. For drug filling, platform products enabling both vented or vacuum filling may also widen the choice of contract filling partners. Drug developers often have further specific criteria, such as branded labelling or patient information to communicate.

Greater choice throughout eases the burden on manufacturers as they come closer to commercialising the final combination product.

From Afterthought to Forethought In the long and pressurised drug development process, and with pharma teams primarily concerned with drug formulation and efficacy, device selection is often an afterthought.

Earlier device assessment could however facilitate planning for future pipelines, in addition to current development drives.

Identifying a platform device that functions with multiple drugs in a portfolio produces future efficiencies and simplifies decisionmaking. Versatile, thoroughly tested platform products offer drug developers reliable and consistent performance, reduced risk, and a more efficient path to market – even as the market evolves.

REFERENCES 1.

2.

3.

International-Pharma. IPI Summer 404243. https://international-pharma.com/ wp-content/uploads/2025/07/IPI-SUMMER4042-43.pdf ONdrugDelivery. From Platform to Product – Accelerating Time to Market for Platform Technologies. https://ondrugdelivery.com/ from-platform-to-product-acceleratingtime-to-market-for-platform-technologies/ U.S. Food and Drug Administration. Platform Technology Designation Program for Drug Development Guidance for Industry. https:// www.fda.gov/media/178938/download

Mark Glass Mark Glass, Director, Owen Mumford Pharmaceutical Services. With a strong scientific background and over 20 years of experience in the pharmaceutical sector, Mark Glass has delivered innovative solutions to drug developers across the globe. His career spans the full product lifecycle, from clinical development through to commercialisation, navigating complex regulatory environments. He has worked with a diverse range of customers, from single-product innovators to multinational pharmaceutical giants, equipping him with the insight and agility to foster long-term, mutually beneficial partnerships.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 43

Clinical and Medical Research

Automated Liquid Handling to Advance 3D Cell Culture 3D cell culture technology is rapidly gaining traction in drug discovery workflows, in particular for in vitro testing and simulation of disease progression and therapeutic response. Adding further momentum is the recent introduction of the UK roadmap to phase out animal testing with organon-a-chip and organoid methodologies set to become a critical aspect of many preclinical testing protocols.1 Building on the original 3Rs principle of Replacement, Reduction, and Refinement, efforts are shifting to introduce non-animal-based methods into research.

By bridging the gap between in vitro and in vivo models, 3D cell cultures can provide fundamental information on cellular functions, signalling pathways, and nuclear activities. Through accurately mimicking human tissue-like structures, 3D models provide a better representation of the in vivo environment, than traditional 2D cell cultures, and can therefore provide useful predictive insights into in vivo responses to drug treatment. However, 3D models are not yet widespread in preclinical testing, often hindered by limitations associated with their development and standardisation.

Overcoming these challenges will require innovative solutions to reduce variability and increase reproducibility before 3D models can be adopted as standard.

3D Models to More Accurately Model In Vivo Conditions 3D models offer significant advantages over traditional 2D cell models, increasing cellto-cell contacts and allowing the culture to grow and interact with the surrounding extracellular environment, more accurately reflecting living tissue (Figure 1.).

The very first example of a 3D cell model was in 1970, when Sutherland and colleagues developed a multicellular spheroid culture to create a functional phenotype of cancer cells, and then used the model to evaluate these cells’ response to radiotherapy.2,3 Spheroids are simple cellular aggregates that contain both internal and external layers of cells with varying exposure to the external environment, simulating the 44 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Figure 1. Comparison of 3D and 2D Cell Culture Models

gradient of nutrients and oxygen seen in in vivo conditions.

The next phase of 3D cell culturing included organoids: more complex structures than spheroids, offering a simplified model system of organs that better reflect organ architecture and functionality.4 Further to this, researchers developed organ-on-a-chip, the most advanced model-type to date that mimics the activities, mechanisms, and physiological processes of organs and organ systems, and has the potential to replace animal models in drug testing studies (Figure 2.).5 Modelling Tumour Microenvironments to Enhance Cancer Treatment Oncology continues as an area where in vitro 3D modelling can be particularly useful, with

many new drugs failing in early clinical trials, in part due to the ineffectiveness of 2D in vitro assays.

Tumours are made up of multiple different cell types, creating the tumour microenvironment (TME), which in turn drives the evolution of the tumour. The heterogeneity of different patients’ TMEs contributes strongly to response to different therapies and as such, being able to accurately model the TME is crucial for effective personalised therapies against cancer. Although not fully reflective of the TME, 3D cell cultures more accurately represent the genomic diversity of the TME than 2D cell cultures, and allow for generation of patient-derived cell lines that cannot be grown in 2D. 3D cultures also create a microenvironment that can provide

Figure 2. Development of 3D cellular models from spheroids to organoids to organ-on-a-chip technologies Spring 2026 Volume 18 Issue 1

Clinical Regulatory and Medical & Marketplace Research insights into how cancer cells behave in vivo, facilitated by dimensionality, presence of an Extracellular Matrix (ECM), and concentration gradients.

Cell migration occurs in all three dimensions and therefore requires 3D models to investigate the invasion and metastasis of tumours. An example of this was demonstrated in lung cancer where researchers used a 3D culture device to study the invasion of lung carcinoma.6 Interactions between tumour cells and the ECM has been shown to impact tumour progression and response to therapeutic intervention, both of which can be monitored through 3D cell models.7,8 It is also possible to recreate the concentration gradients of soluble metabolites, oxygen, and pH that are seen in the TME, with cells closest to blood vessels having access to more soluble components.

This gradient can also impact the diffusion of drugs through the tumour and remains a major obstacle in cancer therapy.9 Bringing these advantages into play, recent, more advanced 3D models have enabled research into specific cancer types, for example prostate cancer.10 As the second leading cause of tumour mortality among men in the western world, treatment of prostate cancer has become a key research focus. 3D cell cultures have enabled monitoring of drug bioavailability, therapeutic efficacy, and dose limiting toxicity in prostate cancer treatment, all in a cost-effective, high-throughput manner.

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Traditional cell culture methods involve the use of prostate cancer cell lines, most commonly LNCaP, PC3, and DU145 cells, grown in a 2D layer. To overcome the limitations of 2D models, several approaches to 3D cell culture have been developed specifically for prostate cancer, including aggregation, hanging drop, microfluidic devices, and the use of immortalised prostate cancer cell lines.

Advances in biomaterials and micro-fabrication are continuing to drive the development of more accurate prostate cancer models, including those developed from stromal, endothelial, and immune cells.

Treatment options for prostate cancer vary widely depending on the staging of the tumour, including hormone therapy, radiotherapy, and chemotherapy. 3D cell models have enabled the optimisation of each of these approaches.

For example, in radiotherapy, cell spheroids confirmed the use of Surface-enhanced Raman spectroscopy to assess treatment response, while for chemotherapy, 3D models can be used to demonstrate the efficacy of doxorubicin at both suppressing tumour growth and increasing drug penetration in tumour tissues.11,12,13 There is also opportunity for highly personalised 3D cell models.14 By generating models from patient-derived explants, which are freshly excised tumour samples, tissue can be grown on sponge scaffolds, maintaining the original tumour structure and allowing for direct evaluation of treatment approaches on a specific patient’s tumour sample, enabling

development of personalised treatment strategies.

Challenges Associated with 3D Cell Cultures While 3D cell cultures are certainly beneficial over 2D cell cultures, there are still challenges limiting their wide-scale roll-out. In many cases, choosing between 2D and 3D models requires a compromise: traditional 2D models are well established, with vast amounts of literature evidence supporting their effectiveness, and relatively inexpensive to produce, but these models are significantly less representative of a real cell environment than 3D structures.

Variability represents a significant challenge in the development of 3D cell models; a lack of guidelines and standardised methodologies has so far hindered the use of such models, while limiting their reproducibility for use in preclinical trials.

Current models can vary greatly in terms of complexity, size, morphology, and culturing methodology, which not only limits the application of the models, but also their subsequent imaging and analysis. The assays used to study 3D cultures are less standardised than those used for 2D cultures, representing a significant opportunity for instrument providers to develop appropriate automated platforms.3 Automated Platforms for More Reproducible Results As with most drug discovery and cell culture workflows, liquid handling plays a critical

INTERNATIONAL PHARMACEUTICAL INDUSTRY 45

Clinical and Medical Research role in ensuring reproducible results. By standardising workflows and minimising human errors, automated liquid handling systems ensure reliable and reproducible results, essential for the development of accurate, robust 3D models.15 In cancer, there are several examples of automated systems enabling development of accurate cell models. As described by Brandenberg, N. et al (2020), automated methods for suspension culture can be used to generate thousands of individual gastrointestinal organoids trapped in microcavity arrays within a polymerhydrogel substrate. The absence of a solid matrix standardises the organoids, and the models were used to screen drug candidates for colorectal cancer.16 Personalised stem-cell based organoids can also be established from various epithelial tissues and cancers using automated protocols, including for head and neck squamous cell carcinoma.17 There are cases in which automation of 3D cell culturing can be challenging, for example, when using a scaffold-based approach. Their viscosity makes them incompatible with some liquid handling tools, while their thickness and low transparency pose challenges for imaging.

In these situations, extrusion bioprinting strategies can enable production of both low and high viscosity solutions, increasing reproducibility and resolution.

Despite the large upfront costs associated with automated systems, these platforms can reduce costs over the long term by minimising waste and maximising output through precise liquid handling. A further consideration for automated liquid handling is the use of appropriate consumables.18 High quality, robust consumables from approved suppliers can help to reduce error margins, facilitating more efficient reagent management, and ensuring lot-to-lot consistency. In addition, use of reliable consumables on an automated system minimises the need for extra repetitions, resulting in both economic and environmental benefits.

Accurate 3D Cell Models to Enhance Drug Discovery It is clear that 3D cell culturing will play a critical role in the process of phasing out animal models, facilitating a shift towards organoids and organ-on-a-chip technologies, but development of robust models is reliant on standardised workflows and high-quality laboratory essentials to minimise risk of error.

Implementation of automated liquid handling platforms (Figure 3) in 3D cell culturing can facilitate development of accurate, reproducible models, and subsequent 46 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Figure 3. Automated Liquid Handling Platform

development and commercialisation of safe and effective therapeutics, with cancer treatments leading the way.

13.

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https://www.gov.uk/government/news/animaltesting-to-be-phased-out-faster-as-uk-unveilsroadmap-for-alternative-methods Sutherland, R. M., et al. A Multi-component Radiation Survival Curve Using an in Vitro Tumour Model. Int. J. Radiat. Biol. 18, 5, 491-495 (1970) Urzi, O., et al. Three-Dimensional Cell Cultures: The Bridge between In Vitro and In Vivo Models.

Int J Mol Sci. 27, 24, 15 (2023) Hofer, M., & Lutolf, M, P. Engineering organoids.

Nat Rev Mater. 6, 402-420 (2021) Ortiz-Cardenas, J, E., et al. Towards spatiallyorganized organs-on-chip: Photopatterning cell-laden thiol-ene and methacryloyl hydrogels in a microfluidic device. Organson-a-Chip. 4 (2022) Wang, S., et al. Study on Invadopodia Formation for Lung Carcinoma Invasion with a Microfluidic 3D Culture Device. Plos One (2013) Boyle, S, T., et al. Acute compressive stress activates RHO/ROCK-mediated cellular processes. Small GTPases. 11, 5, 354-370 (2020) Sun, Y. Tumor microenvironment and cancer therapy resistance. Cancer Letters. 380, 1, 205215 (2016) Minchinton, A, I., & Tannock, I, F. Drug penetration in solid tumours. Nat Rev Cancer. 6, 583-592 (2006) Fontana, F., et al. Three-Dimensional Cell Cultures as an In Vitro Tool for Prostate Cancer Modeling and Drug Discovery. Int J Mol Sci. 16, 21, 18, 6806.

Camus, V, L., et al. Measuring the effects of fractionated radiation therapy in a 3D prostate cancer model system using SERS nanosensors.

Analyst. 141, 5056-5061 (2016) Kuniyasu, H., et al. Interferon-alpha prevents selection of doxorubicin-resistant undifferentiatedandrogen-insensitive metastatic human prostate

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cancer cells. The Prostate. 49, 1, 19-29 (2001) Peng, ZH., & Kopecek, J. Enhancing Accumulation and Penetration of HPMA Copolymer– Doxorubicin Conjugates in 2D and 3D Prostate Cancer Cells via iRGD Conjugation with an MMP-2 Cleavable Spacer. J Am Chem Soc. 137, 21 (2015) Centenera, M, M., et al. Evidence for Efficacy of New Hsp90 Inhibitors Revealed by Ex Vivo Culture of Human Prostate Tumors. Clin Cancer Res. 18, 13, 3562-3570 (2012) Costamagna, G., et al. Advancing Drug Discovery for Neurological Disorders Using iPSC-Derived Neural Organoids. Int J Mol Sci. 22, 5, 2659 (2021) Brandenberg, N., et al. High-throughput automated organoid culture via stem-cell aggregation in microcavity arrays. Nat Biomed Eng. 4 863-874 (2020) Driehuis, E., et al. Establishment of patient-derived cancer organoids for drug-screening applications.

Nat Protoc. 15, 3380-3409 (2020) Siebels, B., et al. Assay for Characterizing AdsorptionProperties of Surfaces (APS). Chemistry. 30, 68 (2024)

Imran-Ali Vasi Imran-Ali Vasi is a Commercial Product Manager at Eppendorf, focusing on driving accessible and practical laboratory automation across EMEA. Drawing on his background at QIAGEN, he combines deep technical understanding with commercial insight, working across sales, R&D and marketing to help customers adopt workflow drive solutions that deliver real operational impact.

Spring 2026 Volume 18 Issue 1

Clinical Regulatory and Medical & Marketplace Research

Xenotransplantation: Regulatory and Ethical Considerations with Best Practices for Sponsors and IRBs Xenotransplantation, the use of animal organs in human recipients offers a possible solution to organ shortages but faces notable scientific, ethical, and regulatory hurdles. Major issues include immune rejection, zoonotic infection risks, long-term monitoring, participant vulnerability, animal welfare concerns, and equitable access. Effective oversight, transparent consent, multidisciplinary collaboration, and ongoing research are essential for success of clinical trials.

This article reviews major ethical and regulatory considerations and outlines recommended practices for sponsors and Institutional Review Boards (IRBs) engaged in xenotransplantation clinical trials.

The global shortage of human donor organs remains one of the most persistent and lifelimiting challenges in modern medicine.

Thousands of patients die each year while waiting for a suitable organ, highlighting the need for innovative solutions. In the United States, more than 103,000 people are on the transplant waiting list, and 13 die daily waiting for organs. About 86% need a kidney, 9% need a liver, and 3% need a heart.1 Xenotransplantation, the transplantation of organs, tissues, or cells from non-human animals into humans has emerged as a promising frontier, potentially offering a virtually limitless supply of donor organs. With recent advances in genetic engineering and immunology, the transplantation of genetically modified pig organs into human recipients is transitioning from experimental feasibility to clinical reality. However, this unprecedented progress brings equally significant regulatory, ethical, and public health challenges. A deeper look at the key ethical and regulatory issues will provide recommended practices for sponsors and Institutional Review Boards (IRBs) involved in xenotransplantation clinical trials.

Scientific Advances and Remaining Hurdles The scientific landscape of xenotransplantation has evolved rapidly, driven by the application of gene-editing technologies such as CRISPR to create genetically modified pigs whose organs are less likely to be rejected by the human immune system.2,3,4 www.international-pharma.com

Notable milestones include the successful transplantation of pig hearts and kidneys into human recipients under expanded access protocols, which have demonstrated that animal organs can function in human bodies for limited durations.5 These first-in-human cases are invaluable for understanding immune responses and refining surgical techniques.

Despite these advances, several formidable hurdles remain. Immune rejection, both immediate and delayed, continues to pose a significant challenge, necessitating the use of powerful immunosuppressive therapies with their own risks. The possibility of zoonotic infections, where diseases are transmitted from animals to humans, is a persistent concern, especially with the potential emergence of novel pathogens.6 Vigilant screening, lifetime monitoring of recipients, and surveillance of close contacts are essential strategies to mitigate the risk of zoonosis. However, the possibility of unforeseen infectious outbreaks remains a public health consideration.

The long-term durability and functionality of xenografts are not yet fully understood, and standardising protocols for the production and use of genetically engineered animal organs remains a work in progress. Technical challenges in organ procurement, preservation, and transplantation further complicate the path to routine clinical use.

Ethical Considerations The ethical landscape of xenotransplantation is as complex as its scientific one. Key ethical considerations include the protection of participant autonomy through robust informed consent, the welfare and rights of animal donors, the fair allocation of resources, and the broader social and public health implications of introducing animal organs into human recipients.7,8,9,10 a. Informed Consent and Participant Autonomy Given the experimental nature of xenotransplantation, informed consent is of paramount importance. Participants must be provided with clear, comprehensible information about the procedure’s risks, including immune rejection, zoonotic disease

transmission, and potential long-term complications alongside alternative treatment options (such as traditional transplantation or medical management). The consent process must also address the implications of lifelong monitoring and potential impacts on quality of life. Particular attention is needed for participants with limited options, who may be especially vulnerable to coercion or undue influence. b. Animal Welfare and Rights The use of animals as organ donors raises profound ethical questions about animal welfare and rights. Donor animals, typically pigs, must be bred and maintained in pathogen-free, humane environments, with regulatory oversight ensuring their wellbeing and minimising suffering. Ethical guidelines require that animal use is justified only when there are no viable alternatives and that the benefits to human health are substantial and proportionate. The potential for genetic modification to enhance organ compatibility introduces further ethical complexity, demanding transparency, and public engagement in the development of standards. c. Equity, Access, and Public Perception Equitable access to xenotransplantation is essential to prevent widening disparities in healthcare. The initial high costs and technical complexity of these procedures may limit access to affluent populations unless deliberate efforts are made to ensure fairness.

Additionally, public perception shaped by concerns about “species boundaries,” religious beliefs, and fears of new infectious diseases can influence the acceptance and success of xenotransplantation programs. d. Societal and Psychological Impacts Recipients may experience psychological effects related to identity, stigma, or the burden of lifelong monitoring. The risk to close contacts and the broader public from zoonotic diseases also raises public health and societal concerns. e. Human-Animal Chimeras Xenotransplantation complicates humananimal distinctions, raising ethical debates about species boundaries and moral obligations.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 47

Clinical and Medical Research Regulatory and Ethical Oversight: Role of IRBs Xenotransplantation clinical trials are subject to rigorous regulatory and ethical review to ensure participant safety and scientific integrity. Institutional Review Boards (IRBs) play a central role in this process, guided by the regulatory frameworks outlined in 45 CFR §46.111 and 21 CFR §56.111.11,12 These regulations mandate systematic risk minimisation, equitable participant selection, comprehensive informed consent, ongoing safety monitoring, and additional protections for vulnerable populations.

Best Practices for Sponsors and Investigators Sponsors are instrumental in upholding the scientific rigor, safety, and ethical standards of xenotransplantation clinical trials. They must maintain source animals in pathogenfree, closely monitored herds to minimise zoonotic risks and provide robust preclinical IRB Criteria for Approval 111.a.1 Risks to subjects are minimised by sound research design and using procedures already being performed on the subjects for diagnostic or treatment purposes.

111.a.2 Risks are reasonable in relation to anticipated benefits and the importance of the knowledge.

IRB Review Considerations • • • • • •

•

111.a.3 Selection of subjects is equitable.

• • • • •

111.a.4 Informed Consent

• •

• 111.a.6 Adequate provision for monitoring data collected to ensure the safety of subjects.

111.b Additional protection for vulnerable subjects.

48 INTERNATIONAL PHARMACEUTICAL INDUSTRY

•

•

Weigh benefits to participants against risks including organ rejection, zoonotic infection, and public health implications.

Robust justification for participant inclusion.

Use of immunosuppressive and supportive therapies.

Strategies for early detection of immune rejection, infections to ensure safety and efficacy.

Ensure protocols include lifetime monitoring of recipients, close contacts, and healthcare workers for infectious diseases Ensure multispecialty experts in infectious diseases, immunology, animal husbandry, and bioethics.

Ensure fair and transparent participant selection to uphold justice and prevent exploitation.

Ensure criteria that prioritise individuals with life-threatening conditions and limited treatment alternatives.

Avoid excluding qualified candidates based on socioeconomic status or lack of access to waitlists.

Assess the risk of coercion or undue influence in the selection process.

Ensure robust process due to experimental nature, recipient vulnerability, societal risks Ensure participants have comprehensive understanding of risks and benefits, novelty, immune rejection, zoonotic infection, long-term monitoring, psychological impacts, future healthcare implications.

Look for alternative treatments; protocols for managing graft failure and returning to previous therapies.

Close contacts information about risks and monitoring, especially for infectious disease surveillance.

Lifetime surveillance for infectious disease detection, graft function; protocols for continuous monitoring, registries, tissue/sample banking, quarantine plans, defined responsibilities and funding for monitoring/care.

Collaborate with IBC (Institutional Biosafety Committee), IACUCs (Institutional Animal Care and Use Committees), DSMBs, and regulatory agencies to ensure ongoing compliance and oversight.

Consider research purpose, setting, and special attention for vulnerable groups to prevent coercion or undue influence.

Spring 2026 Volume 18 Issue 1

Clinical Regulatory and Medical & Marketplace Research data, often from non-human primate studies, that demonstrate safety and efficacy.

Participant selection should be equitable, focusing on individuals with life-threatening conditions lacking alternative treatments and ensuring diverse representation.

Lifelong monitoring of recipients and their close contacts, comprehensive registries and sample banking, and independent data safety monitoring are essential for ongoing research and public health. Multidisciplinary teams with experts in infectious disease, immunology, surgery, animal husbandry, and bioethics should oversee trials, utilising accredited laboratories for pathogen screening. Sponsors must collaborate closely with regulatory authorities, including the FDA, IRBs, and IBCs, to ensure timely reporting of adverse events and protocol amendments. Engaging with participants, families, advocacy groups, and the broader public through transparent communication and educational initiatives is vital for fostering trust and acceptance.13 Sponsors should also clearly define responsibilities for the costs of long-term care, both during and after the trial, to support accessibility and proper oversight.

Conclusion Xenotransplantation stands at a transformative juncture in medicine, offering hope to thousands of patients awaiting life-saving organ transplants. Its potential to alleviate organ shortages is matched by significant scientific, ethical, and regulatory challenges that demand careful attention. Responsible advancement requires rigorous scientific

evaluation, robust ethical safeguards, and comprehensive regulatory oversight.

Key priorities include the protection of participant autonomy through informed consent, the humane treatment of animal donors, equitable access to care, and ongoing research to refine clinical protocols and risk mitigation strategies.

Continued dialogue among researchers, regulators, ethicists, and society at large will be essential for navigating the evolving landscape of xenotransplantation.

Following best practices in protocol design, risk assessment, animal welfare, and stakeholder engagement will help to ensure xenotransplantation is safe, ethical, and equitable for all.

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https://www.organdonor.gov/learn/organdonation-statistics Hai T, Teng F, Guo R, Li W, Zhou Q. One-step generation of knockout pigs by zygote injection of CRISPR/Cas system. Cell Res (2014) 24:372–75. doi: 10.1038/cr.2014.11 Cowan PJ, Hawthorne WJ, Nottle MB. Xenogeneic transplantation and tolerance in the era of CRISPR-Cas9. Curr Opin Organ Transplant (2019) 24:5–11. doi: 10.1097/MOT.0000000000000589 Bobier C, Hurst DJ, Rodger D. Xenotransplantation under the Food and Drug Administration's Expanded Access pathway. Am J Transplant. 2024 Oct;24(10):1911-1912. doi: 10.1016/j.ajt.2024.05.015.

Epub 2024 May 22. PMID: 38782186.

George AJ. Ethics, virtues and xenotransplantation.

Perfusion. 2024 Mar;39(2):334-343. doi: 10.1177/02676591221140767. Epub 2022 Nov 16.

PMID: 36382884; PMCID: PMC10900854.

George AJ. Ethics, virtues and xenotransplantation.

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Perfusion. 2024 Mar;39(2):334-343. doi: 10.1177/02676591221140767. Epub 2022 Nov 16.

PMID: 36382884; PMCID: PMC10900854.

Sade RM, Mukherjee R. Ethical issues in xenotransplantation: The first pig-to-human heart transplant. Ann Thorac Surg 2022; 113: 712–714.

Entwistle JW, Sade RM, Drake DH. Clinical xenotransplantation seems close: Ethical issues persist. Artif Organs 2022; 46: 987–994.

Johnson LSM. Existing ethical tensions in xenotransplantation. Camb Q Healthc Ethics 2022; 31: 355–367.

Cengiz N, Wareham CS. Ethical considerations in xenotransplantation: a review. Curr Opin Organ Transpl 2020; 25: 483–488. https://www.ecfr.gov/current/title-45/subtitle-A/ subchapter-A/part-46/subpart-A/section-46.111 https://www.ecfr.gov/current/title-21/chapter-I/ subchapter-A/part-56/subpart-C/section-56.111 Hawthorne WJ. Ethical and legislative advances in xenotransplantation for clinical translation: focusing on cardiac, kidney and islet cell xenotransplantation. Front Immunol. 2024 Feb 7;15:1355609. doi: 10.3389/fimmu.2024.1355609.

PMID: 38384454; PMCID: PMC10880189.

Sharad Adekar Sharad Adekar, MD, PhD, CIP, is a Senior Medical Chair at WCG. He is a physician scientist with clinical experience in family practice and pediatrics and research experience in immunology, oncology, cardiovascular diseases, infectious diseases, and neurology. Dr. Adekar has experience in human antibodies in terms of discovery, lead optimisation, and preclinical development of monoclonal antibody therapeutics.

Ronald Quinton Ronald Quinton, MD, is the medical director of the Goldring Center for Culinary Medicine at Tulane University School of Medicine. He is a certified culinary medicine specialist and is boardcertified in thoracic surgery. Dr. Quinton also serves as an adjunct professor at the Tulane School of Medicine. He graduated from the U.S. Air Force Academy with a degree in life science, then earned a medical degree from the Tulane School of Medicine.

www.international-pharma.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 49

Clinical and Medical Research

Multiplex Antibody Array Technology: Advantages and Applications Proteins are involved in a wide array of biological processes, from apoptosis to cellular checkpoints and inflammation, among others, all of which are pertinent to diseases ranging from cancer to neurodegenerative, cardiovascular, and infectious diseases (Chen et al., 2018).

Consequently, investigating the proteome is crucial for understanding disease pathways and drug action mechanisms, and identifying novel therapeutic targets and noninvasive biomarkers for disease diagnosis, prognosis, and assessing treatment response.

The proteome is complex and dynamic, with protein expression, secretion, posttranslational modifications, and interactions, responding to stimuli and differing between tissues. Accurate proteome mapping therefore requires the analysis of biological samples across multiple pathological states and treatment phases, as well as analytical methods that are simple, rapid, cost-effective, highly reproducible and sensitive. Detection of low-abundant proteins, such as cytokines, angiogenic factors, growth factors, and proteases, is critical, given their central roles in signalling and their potential as therapeutic targets.

Mass spectrometry (MS) is the traditional method for proteome analysis due to its broad coverage, allowing the detection of several thousand proteins in a single liquid chromatography (LC)-MS/MS experiment (Ren et al., 2021). However, this approach requires expensive instrumentation and trained personnel for both sample handling and data analysis. Moreover, when applied to complex biological matrices such as human serum or plasma, high-abundance proteins like albumin and globulins can mask low-abundance proteins, limiting detection below low μg/ml or high ng/ml concentrations without extensive sample fractionation or enrichment to decrease the sample complexity (Ren et al., 2021; Vanarsa et al., 2020). Consequently, MS methods may be inadequate for detecting clinically relevant proteins, as many candidate biomarkers with clinical applicability are present at sub pg/ml to sub ng/ml levels (Ren et al., 2021). Although 50 INTERNATIONAL PHARMACEUTICAL INDUSTRY

targeted MS methods have progressively improved sensitivity to reach detection limits of 50–100 pg/ml, their multiplexing capacity is often restricted to approximately 20–30 analytes per assay (Ren et al., 2021).

To address the limitations of MS-based approaches, immunoassay-based multiplex proteomics technologies have emerged as complementary tools to traditional proteomic methods. These technologies enable the rapid and simultaneous quantification of hundreds to thousands of proteins within a single assay while maintaining high sensitivity, requiring minimal sample preparation and allowing accessible data interpretation.

They are derived from the enzyme-linked immunosorbent assay (ELISA), the most commonly used protein quantification technique in research environments and the clinical gold standard for single-analyte detection. ELISAs achieve detection limits of 1 to 10 pg/ml, without requiring sample pretreatment (Ren et al., 2021).

Technological principles and advantages High-throughput antibody array platforms extend traditional ELISA methodologies by immobilising numerous distinct capture antibodies onto functionalised solid substrates, thereby allowing for the simultaneous quantification of multiple protein targets from one sample. Antibody microarray assays can be completed within 24 h (Chen et al., 2018) and are compatible with a wide range of sample types derived from both in vitro and in vivo models, as well as clinical trials, including serum, plasma, urine, conditioned media, cell lysates, and tissue or biopsy lysates. In addition, these platforms support the analysis of less commonly used biological samples, such as tears, saliva/sputum, synovial fluid, amniotic fluid, dried blood spots, bone extracts, cerebrospinal fluid, breath condensates, bronchoalveolar lavage, gingival crevicular fluid, breast milk, liver cyst fluids, and laser capture-microdissected tissue (Chen et al., 2018; Hong et al., 2022; Hu et al., 2015; Jian et al., 2014; Li et al., 2008). Because each capture antibody binds its target protein independently of other analytes present in the sample, antibody arrays can achieve detection limits down to the sub fg/ml range and exhibit broad dynamic ranges of up to

10-log, while requiring minimal sample preparation (centrifugation/dilution) (Ren et al., 2021).

Antibody arrays can be divided into screening and targeted arrays (see supplementary figure). Screening arrays consist of high-density configurations that enable unbiased profiling of the proteome, allowing the analysis of up to 8,000 analytes or post-translational modifications such as nitrosylation, oxidation, and phosphorylation.

Targeted arrays, by comparison, are designed for the focused and accurate identification of up to 500 analytes associated with specific pathways or biological processes. The technology is particularly advantageous due to its flexible multiplexing capabilities which allow the customisation of array content.

Moreover, antibody arrays are available not only for human targets but also for corresponding analytes in commonly used animal models, including mouse, rat, and others.

Currently available antibody array platforms predominantly use direct or sandwich labelling strategies (Figure 1). After surface reactive groups are blocked, the array is incubated with a sample containing soluble target proteins which are subsequently captured by the immobilised antibodies.

Detection of these binding events is achieved either through direct fluorescent labelling of the sample or via the introduction of a secondary detection reagent. Sandwich assay formats typically offer enhanced specificity since two antibodies directed against distinct epitopes of the antigen are required for signal generation, which occurs only when both antibodies are bound to the target.

The solid supports used in antibody arrays are most commonly composed of glass or nitrocellulose membranes. Membrane-based arrays typically generate signal through fluorescence or chemiluminescence and provide semiquantitative measurements with an approximate 4-log dynamic range, where relative changes in protein abundance are inferred from signal intensity comparisons (Ren et al., 2021). These systems offer the practical advantage of straightforward handling similar to western blot membranes and do not require specialised equipment. In Spring 2026 Volume 18 Issue 1

Clinical Regulatory and Medical & Marketplace Research contrast, more recently developed antibody arrays predominantly use glass slides as solid supports as they enable higher antibody spotting density, increased throughput, and enhanced multiplexing capacity. Glass slide arrays are commonly formatted into 2 × 8 or 16 subarrays, corresponding to two columns of a 96-well microtiter plate, which support automated workflows.

While the parallel processing of multiple subarrays enhances multianalyte detection capacity, it also increases sample volume requirements. Measurement reliability is improved by spotting identical capture antibodies in multiple technical replicates within each subarray, with signal intensities calculated as the mean values. The use of protein standards further supports absolute quantification. Fluorescence-based detection remains the most widely used readout and requires a dedicated microarray scanner.

Currently, quantification panels allow the simultaneous measurement of up to 1,200 human proteins through the combination of 25–30 nonoverlapping glass-slide arrays, each subarray multiplexing 40 proteins, resulting in protein quantification efficiencies up to 80 times greater than those of conventional ELISA assays (Ren et al., 2021).

Figure 1 (Reproduced from Ren et al., 2021, under the terms of the CC BY-NC-ND license): Multiplex antibody arrays consist of distinct capture antibodies immobilised on a solid support. In the direct label assay format (left), proteins extracted from the biological sample are biotin-labelled prior to incubation on the array, enabling binding of target analytes to the capture antibodies. Following washing steps, Cy3-labeled streptavidin is added to bind to the biotin tags. In contrast, the sandwich label format (right) involves direct incubation of the biological sample on the array to allow target binding.

Following washing, a biotin-conjugated detection antibody is added to form immunocomplexes, and subsequent washing is followed by the addition of Cy3-labeled streptavidin to generate the detection signal.

Applications in Basic and Clinical Research With panels covering signalling pathways, cell cycle, transcription factors, tumour markers, inflammation-related and disease-specific proteins, the applications of antibody arrays range from the identification of disease biomarkers and novel therapeutic targets to the unveiling of disease and drugs action mechanisms, including resistance and side effects. Indeed, as changes in signalling pathways are a hallmark of many disease states, including cancer, diabetes, and neurodegenerative disorders (Chen et al., 2018), comparing the protein expression and modification profiles in samples of normal vs pathological states or from model systems before and after drug treatment enables researchers to investigate changes involved

MASS SPECTROMETRY

ANTIBODY ARRAYS

Number of detected proteins

Up to 10.000

Up to 8.000

Protein detection limitations

Sample matrix complexity

Availability of specific antibodies

Sample preparation

Protein enrichment, depletion, or fractionation

Minimal to none

Detection of low-abundance proteins

High abundance proteins may interfere

Yes

Dynamic range (Ren et al., 2021)

4- to 6-log

Up to 10-log

Instrumentation

Mass spectrometer

Chemiluminescent detector or laser scanner

Training

Extensive

Minimal

Table 1: Main differences between mass spectrometry and antibody array technology. www.international-pharma.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 51

Clinical and Medical Research in disease progression, drug interaction, and response to treatments.

Moreover, affinity-based methods are particularly well suited for analysing clinical samples, thanks to their superior sensitivity and specificity for detecting low-abundance proteins, as well as their capability for highthroughput analysis of multiple targets with minimal sample input and preprocessing (Wang et al., 2025). Analysis of clinical samples at the protein level can be used for diagnosis and prognosis (Veyssière et al., 2022), but also to direct treatment options by providing detailed real-time insights about the current state of the disease, thus improving management of patient care.

In particular, high-density antibody arrays have recently emerged as powerful tools to decode immune interactions in the tumour microenvironment (TME) by rapidly and accurately analysing the secretion profiles across diverse sample types (Wang et al., 2025). The TME has a crucial role in cancer progression and in modulating therapeutic efficacy and resistance, through complex cellular crosstalk involving diverse signalling molecules (cytokines, chemokines, growth factors, and matrix-degrading enzymes) secreted by tumour stromal cells (Wang et al., 2025). Mapping this dynamic balance in clinical samples of plasma (Harel et al., 2022), peripheral blood mononuclear cells (LazaBriviesca et al., 2021) or cancer-associated fibroblasts (Hu et al., 2021) derived from patients with non-small cell lung cancer has revealed a correlation between an immunostimulatory or immunosuppressive TME and response to treatment with immune checkpoint inhibitors, chemoimmunotherapy or targeted therapy, respectively. Moreover, serum and tumour infiltrate profiling of samples from mouse models with highlyrefractory triple-negative breast cancer treated with a combination of immune checkpoint therapy (ICT) and innate immune activators has shown distinctive immune activating cytokine profiles engaging both innate and adaptive immunity, offering a new therapeutic strategy to treat ICTrefractory solid tumours (Gonzalez et al., 2023). These findings have deepened our understanding of the TME, as well as helped identify predictive biomarker signatures for response and uncover drug resistance and immune escape mechanisms.

glycosylation and phosphorylation of proteins, can help to monitor disease evolution and predict outcomes.

Indeed, changes in glycosylation often occur early in disease progression (Ohtsubo & Marth, 2006, Yu et al., 2025). For example, in oncology, high-density glycosylation antibody array covering ~1,000 proteins can serve to identify glycosylation-based biomarkers for early detection of pancreatic cancer and its precursor lesion, intraductal papillary mucinous neoplasm (IPMN) (Aronsson et al., 2018). A panel including CA19-9, IL-17E, B7-1, and DR6 achieved excellent discrimination of stage I pancreatic cancer from healthy controls, while glycosylated B7-1 showed strong performance for distinguishing IPMN from healthy individuals. This serum protein glycosylation profiling can significantly enhance diagnostic accuracy and holds promise for non-invasive early detection of pancreatic cancer and precursor lesions.

Likewise, abnormal phosphorylation is a cause or consequence of many diseases (Cohen, 2001) and analysing the phosphorylation profile can help to monitor the molecular evolution of cancer over time, rather than providing only a static snapshot at diagnosis (Neradil et al., 2019). By measuring dynamic changes in kinase phosphorylation, these arrays can capture how tumour signalling networks adapt during treatment, relapse, and metastasis. Particularly, serial analysis of tumour samples from the same patient reveals shifts in dominant signalling pathways as the disease progresses or under therapeutic pressure. For example, receptor tyrosine kinases (RTKs) and downstream pathways (ERK, AKT, MAPKs) showed treatment-induced suppression, reactivation, or pathway switching, reflecting tumour adaptation and emerging resistance (Neradil et al., 2019). Importantly, the phosphosignatures differ substantially between primary tumours, relapses, and metastases, emphasizing interpatient heterogeneity and the inadequacy of relying on a single baseline biopsy. Overall, the phospho-protein

arrays can serve as a longitudinal monitoring tool, capable of tracking signalling changes during cancer evolution, informing real-time therapeutic adjustments and improving understanding of resistance mechanisms in paediatric solid tumours.

Perspectives Multiplex antibody arrays critically complement traditional proteomics methods, bringing researchers closer than ever before to elucidating the intricate inner workings and cross talk that spans a multitude of proteins in disease mechanisms, alleviating demands on time, cost, and sample volume. These arrays have increasingly become an attractive tool for the exploratory detection and study of protein abundance, function, pathways, and potential drug targets, offering the unique opportunity to gain a holistic view of the biochemically complex environments involved in pathogenesis and responses to treatment.

In the clinical context, human biological samples are often restricted in availability and quantity. Multiplex arrays have enabled opportunities to identify novel disease biomarkers as well as generating unique proteome signatures with the convenience of low-volume samples. This information will be of great value in the future, enabling better disease management through improved diagnostics and the ability to track disease status and therapeutic efficacy.

REFERENCES 1.

2.

3.

Aronsson, L., Andersson, R., Bauden, M., Andersson, B., Bygott, T., & Ansari, D. (2018).

High-density and targeted glycoproteomic profiling of serum proteins in pancreatic cancer and intraductal papillary mucinous neoplasm.

Scandinavian Journal of Gastroenterology, 53(12), 1597-1603.

Chen, Z., Dodig-Crnković, T., Schwenk, J. M., & Tao, S. C. (2018). Current applications of antibody microarrays. Clinical Proteomics, 15(1), 7.

Cohen, P. (2001). The role of protein phosphorylation in human health and disease.

The Sir Hans Krebs Medal Lecture. European Journal of Biochemistry, 268(19), 5001-5010.

Supplementary Figures: RayBiotech

High-density antibody arrays are also powerful tools to analyse Post-Translational Modifications (PTMs). For example, the analysis of the two most important PTMs, 52 INTERNATIONAL PHARMACEUTICAL INDUSTRY

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Clinical Regulatory and Medical & Marketplace Research 4.

5.

6.

7.

8.

9.

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11.

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Gonzalez, C., Williamson, S., Gammon, S. T., Glazer, S., Rhee, J. H., & Piwnica-Worms, D. (2023). TLR5 agonists enhance anti-tumor immunity and overcome resistance to immune checkpoint therapy. Communications Biology, 6(1), 31.

Harel, M., Lahav, C., Jacob, E., Dahan, N., Sela, I., Elon, Y., ... & Shaked, Y. (2022). Longitudinal plasma proteomic profiling of patients with non-small cell lung cancer undergoing immune checkpoint blockade. Journal for ImmunoTherapy of Cancer, 10(6), e004582.

Hong, S., Park, K. H., Lee, Y. E., Lee, J. E., Kim, Y. M., Joo, E., & Cho, I. (2022). Antibody microarray analysis of amniotic fluid proteomes in women with cervical insufficiency and short cervix, and their association with pregnancy latency length. PloS ONE, 17(2), e0263586.

Hu, C., Huang, W., Chen, H., Song, G., Li, P., Shan, Q., ... & Li, Y. (2015). Autoantibody profiling on human proteome microarray for biomarker discovery in cerebrospinal fluid and sera of neuropsychiatric lupus. PLoS ONE, 10(5), e0126643.

Hu, H., Piotrowska, Z., Hare, P. J., Chen, H., Mulvey, H. E., Mayfield, A., ... & Engelman, J. A. (2021).

Three subtypes of lung cancer fibroblasts define distinct therapeutic paradigms. Cancer Cell, 39(11), 1531-1547.

Jiang, W., Mao, Y. Q., Huang, R., Duan, C., Xi, Y., Yang, K., & Huang, R. P. (2014). Protein expression profiling by antibody array analysis with use of dried blood spot samples on filter paper. Journal of Immunological Methods, 403(1-2), 79-86.

Laza‐Briviesca, R., Cruz‐Bermúdez, A., Nadal, E., Insa, A., García‐Campelo, M. D. R., Huidobro, G., ... & Provencio, M. (2021). Blood biomarkers associated to complete pathological response on NSCLC patients treated with neoadjuvant chemoimmunotherapy included in NADIM clinical trial. Clinical and Translational Medicine, 11(7), e491.

Li, S., Sack, R., Vijmasi, T., Sathe, S., Beaton, A., Quigley, D., ... & Mcnamara, N. A. (2008).

Antibody protein array analysis of the tear film cytokines. Optometry and Vision Science, 85(8), E653-E660.

Neradil, J., Kyr, M., Polaskova, K., Kren, L., Macigova, P., Skoda, J., ... & Veselska, R. (2019).

Phospho-protein arrays as effective tools for screening possible targets for kinase inhibitors and their use in precision pediatric oncology.

Frontiers in Oncology, 9, 930.

Ohtsubo, K., & Marth, J. D. (2006). Glycosylation in cellular mechanisms of health and disease.

Cell, 126(5), 855-867.

RayBiotech. (n.d.). RayBiotech: Antibody arrays, cytokine arrays, and ELISA kits. https://www. raybiotech.com/ Ren, A. H., Diamandis, E. P., & Kulasingam, V. (2021). Uncovering the depths of the human proteome: antibody-based technologies for ultrasensitive multiplexed protein detection and quantification. Molecular & Cellular Proteomics, 20, 100155.

Vanarsa, K., Soomro, S., Zhang, T., Strachan, B., Pedroza, C., Nidhi, M.,... & Mohan, C. (2020).

Quantitative planar array screen of 1000 proteins uncovers novel urinary protein biomarkers of lupus nephritis. Annals of the

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Rheumatic Diseases, 79(10), 1349-1361.

Veyssière, H., Bidet, Y., Penault-Llorca, F., Radosevic-Robin, N., & Durando, X. (2022).

Circulating proteins as predictive and prognostic biomarkers in breast cancer. Clinical Proteomics, 19(1), 25.

Wang, Y., Luo, S., Dong, H., & Huang, R. P. (2025).

Unraveling tumor cell-tumor microenvironment crosstalk through antibody array technologies.

International Journal of Oncology, 67(4), 81.

Yu, H., Chen, X., Yang, Y., Gu, M., Ren, K., & Wei, Z. (2025). Decoding glycosylation in neurodegenerative diseases: mechanistic insights and therapeutic opportunities. The FASEB Journal, 39(20), e71160.

Eric Mennesson Project manager at Tebubio, specialising in protein and RNA biomarkers. He has extensive experience in affinity technologies for biomarker analysis, as well as in-depth expertise in in vitro cell models.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 53

Technology

Building the Right Team and Resource Model to Support Quality System and Validation Activities Since life science quality and validation projects can vary widely in scope and complexity, each specific project needs to be evaluated in order to determine the resources and technical disciplines appropriate for anticipated tasks.

Highly trained specialists in the areas of regulatory, quality, IT, engineering and others, are relied upon to plan, implement, and monitor qualification and/or validation activities in highly regulated industries, such as pharmaceutical and medical device manufacturing. These projects and programmes may include activities like writing and executing CQV and CSV protocols; ensuring documentation, SOPs, laboratory, manufacturing and packaging operations are robust; creating and running test scripts; analysing existing processes for improvement opportunities; and auditing the documentation trail for compliance.1 The processes behind these activities must demonstrate that they lead to a consistent, high-quality product, and are central to producing safe and effective products in a fully compliant state. This article describes critical steps an organisation can follow to ensure Commissioning, Qualification and Validation (CQV) and Computer Software Assurance (CSA) programme success every time.2 Forming the right team and staffing model from the get-go with the right skillset is critical before the project even initiates.

Creating a Multi-Disciplinary Team of Specialists The practice of using multi-disciplinary teams to support the qualification and validation of new or modified systems, facilities, and processes has become an expectation of the FDA as well as many other regulatory agencies in ICH markets. In addition to drafting and executing protocols, effective quality and validation teams also ensure that any changes made to systems, equipment or processes do not result in compliance gaps.

Finding, evaluating, and securing the right talent for a specific validation project can be a challenge. However, the following types of expertise should be evaluated to help you get the right team established from the project 54 INTERNATIONAL PHARMACEUTICAL INDUSTRY

start. Oftentimes, organisations look to specialised consulting and staffing companies with the required level of expertise to fulfil their needs. Sometimes they even outsource the entire validation and quality effort to focus on other high priority projects. A winning formula would be for organisations to ensure they are properly staffed at the right time and can flex to meet changing resource requirements.

Skillsets to Look for: Operations Expertise (Filling, Packaging, Assembly, CSV, CQV, Controls, etc.)

Determine if, and to what degree your project will require, highly specialised support. Is direct equipment or process experience critical or valuable? For example, a pharmaceutical manufacturer may need specific operations support in formulation, equipment/component preparation, final filling, product inspection, and packaging.

Defining these skillsets for your specific project is helpful in both assessing candidates for specific capabilities, and once your team is built, ensuring you have the expertise to support those areas.

•

Which specific operations will you need to support?

•

What skills, capabilities, or experience are essential to ensuring those unit operations can be adequately supported?

What skills, capabilities, or experience are essential to ensuring those unit operations can be adequately supported?

Carefully evaluate and consider all requirements related to the product and equipment to ensure your specialists have the knowledge and experience to perform the activities they are supporting and responsible for.

•

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What are the specific requirements for the product, equipment, or project in question?

What specific qualities, capabilities, or experience must a specialist have to satisfy these requirements? For example, is previous sterile room experience critical?

Environmental Requirements (Aseptic, Non-Aseptic, BSL, Cyto/Gen Toxic, etc.)

Similar to product requirements, does the project or programme require the validation and quality team to operate within a restricted environment? Do they need to be aseptic area qualified with years of experience operating in that environment?

If a specialist lists themselves as having performed EMPQ support, for instance, probe further to understand what that means in terms of tangible project work. More importantly, determine which questions you need to ask in order to understand how they apply the experience within the context of your project. This is one area where routine validation projects with more general requirements differ from specialised process work where specific experience may play a larger role.

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What specific environmental requirements for the product or project are in question?

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What specific qualities, capabilities, or experience must a specialist have to satisfy these environmental requirements?

Vision Inspection Systems (Defect Sets, Defect Logs, Personnel Qualification, etc.)

Some Validation and Quality projects may require specialists who have experience with vision inspection systems. This type of expertise can be difficult to find if it necessitates knowing the requirements for validating camera systems.

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What specific inspection equipment are you looking to validate?

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What are the internal requirements for the system?

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Do you have defect sets needed to validate such equipment?

Strong Documentation Skills GMP (Compliant Documentation, Protocol Generation, Digital expertise, etc.)

If the project involves drafting and executing documents, specialists must be able to produce documentation that complies with both internal SOPs and external regulations.

Spring 2026 Volume 18 Issue 1

Technology Having backgrounds and personal experience navigating the rigours of creating compliant documents that are genuinely clear and easy to follow are critical.

•

Which specific operations will you need to support?

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What is the expectation for specialists in terms of protocol drafting and execution?

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What is the training process required prior to gaining access to the internal documentation control system?

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Will the specialists be required to initiate and drive change controls?

Selecting the Right Resource Model: An Opportunity for Managed Services After determining the skillsets you need for your programmes, it’s important to consider how you will staff your team. There are different staffing models that can be considered – from hiring in-house to staff augmentation to a full managed services engagement. The advantages and disadvantages of each model are depicted below in Figure 1.

to market, while having the confidence that your regulatory and compliance requirements are met.

The following functional areas are best suited by a managed services solution that can take over the entire function and implement best practices. It also provides full visibility into how the function fits into the bigger drug development, go-to-market and commercial production strategies.

Computer Systems Validation (CSV) While a highly specialised and essential area, CSV is a paramount for regulatory compliance, and these activities from custom should not be treated lightly. It is a capability that all life sciences companies must perform consistently and accurately. CSV is a multi-faceted function covering a wide range of validated computer systems across the entire business. At any point it can span the research, clinical testing, manufacturing and distribution process. It is especially complicated with the influx of cloud-based computer systems along with the traditional on-premise systems. This added complexity is why most organisations would benefit from wrapping their quality and compliance functions into a managed services

Figure 1: In-House vs Outsourcing Staffing Models

Many organisations look to outsourcing because it affords a flexible, scalable and oftentimes, less expensive model for hiring the expertise they need. While staff augmentation had traditionally been the model of acquiring staff, it does have its own drawbacks. Enter managed services: A flexible solution that offers a unique combination of a deeper, ongoing partnership and institutional knowledge, while optimising processes and implementing continuous improvements.

A managed services model allows your internal employees to focus on the company’s core business of bringing medical products www.international-pharma.com

engagement, from vendor auditing through computer system validation testing.

Client Value •

Ensure consistent and compliant CSV with expert insight and services, from custom implementations to agile project and audit management

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Transform your review and approval process with the strategic implementation of industry-leading tools, plus expert training and ongoing maintenance

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Implement best-in-class processes that allow you to have the confidence in the accuracy, reliability and consistency all while ensuring data integrity is maintained

Commissioning, Qualification and Validation (CQV) Ensuring that manufacturing facilities, equipment and utilities are commissioned and qualified, and that processes are validated, is critical for success in the life sciences industry.

In addition to optimising the cost of ownership and maintaining your manufacturing systems in a validated state, a managed service approach provides continuous improvements to ensure assets are optimised and running as effectively and efficiently as possible. It also actively supports operations so emphasis can be placed on customers and business needs.

Client Value •

Ensure equipment, facilities and processes are maintained in a validated state utilising the latest technologies and proven delivery strategies from upfront project planning through process validation

•

Employ diverse and flexible technical expertise and cost-effective staffing strategies and software tools (such as paperless validation) to deliver projects on schedule and on budget to accelerate speed to market

•

Implement continuous improvements that result in improved system reliability, increased efficiency and cost reductions

Information Management and Analytics (IMA) All organisations must deal with a variety of data from applications, third party vendors and government agencies. Managing this information in a highly regulated industry can be difficult and time consuming, as well as risky. Regulatory bodies require data integrity throughout the produce lifecycle to ensure that products are safe. Many organisations do not have the time, resources or skills to do this effectively. Managing data and analytics involves organising, labelling and structuring information from disparate sources while following guidelines such as ALCOA+, GDPR and the Sunshine Act. While this area can be complex, it is very well defined and repeatable under a solid data architecture. With hundreds, if not thousands, of integration and consolidation programmes, this can be overwhelming INTERNATIONAL PHARMACEUTICAL INDUSTRY 55

Technology

for IT departments. Most of the activities such as meta data and data integration can be performed via a managed services provider.

Client Value •

•

•

Offload mundane, repeatable and known activities such as data wrangling, test and training model preparation, model tuning and optimisation so your data scientist can do more and experience better job satisfaction Draw actionable insights from raw data via advanced analytics and best practice steps Employ critical thinking experts who ask the right questions to meet key success metrics in the analytics-related field

It is entirely possible to outsource specific functions that make the most sense to one or multiple MSPs depending on your relationship and preferences. This does not relieve the company from its compliance obligations, so the final approval is always up to an internal team member. These areas merely scratch the surface of where and how an MSP can support your organisation so you can focus on your core business – bringing safe and compliant products to market.

No matter where you are in the product development or commercialisation lifecycle, building a team from the start that has the right expertise, is an imperative for all validation and quality projects. A thoughtful evaluation of your project needs and building the right team can make the difference between project success or failure. Dedicating more time at the beginning of a project to

detail the specific skillsets you require is a critical first step. During the next step, building and hiring the team, it’s important to not take shortcuts and bring on board professionals who possess the level of expertise you need. Hiring in-house resources may be a good option, however it may not be feasible or scalable for every function your projects require. Outsourcing these roles to a strategic partner who specialises in areas such as system validation, compliance, quality and data integrity may be a good option for enhanced expertise, value, scale, and ROI. REFERENCE 1.

2.

https://verista.com/computer-system-validationcsv-in-life-sciences-part-1-introduction-to-csv/ https://verista.com/csvtocsa/

Scott Beasley Scott Beasley is an accomplished engineering leader with over 30 years of experience in the pharmaceutical and animal health industries, including roles at Eli Lilly, Elanco, and Verista. He has led large teams, major capital projects, and facility startups across manufacturing, packaging, and distribution. His expertise includes project management, process improvement, and regulatory compliance.

He holds an MBA from Butler University and a Bachelor of Science in Mechanical Engineering from Rose‑Hulman Institute of Technology.

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Spring 2026 Volume 18 Issue 1

Media and Communications

IPI

Peer Reviewed, IPI looks into the best practice in outsourcing management for the Pharmaceutical and BioPharmaceutical industry. www.international-pharma.com

JCS

Peer Reviewed, JCS provides you with the best practice guidelines for conducting global Clinical Trials. JCS is the specialist journal providing you with relevant articles which will help you to navigate emerging markets. www.journalforclinicalstudies.com

IAHJ

Peer Reviewed, IAHJ looks into the entire outsourcing management of the Veterinary Drug, Veterinary Devices & Animal Food Development Industry. www.international-animalhealth.com

IBI

Peer reviewed, IBI provides the biopharmaceutical industry with practical advice on managing bioprocessing and technology, upstream and downstream processing, manufacturing, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more. www.international-biopharma.com

PNP

Pharma Nature Positive, is a platform for all stakeholders in this industry to influence decision making by regulators, governments, investors and other service providers to achieve Nature Net Positive Results. This journal will enable pharma the ability to choose the right services to attain this goal. www.pharmanaturepositive.com

PHARMA POD

‘Putting science into conversation, and conversation into science.’Join some of the most esteemed and integral members of the Drug Discovery & Development world as they give insights & introspect into the latest movements, discoveries and innovations within the industry.

www.international-pharma.com

senglobalcoms.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 57

Technology

Five Ways AI Will Reshape Life Sciences in 2026: Why People, Process, and Purpose Matter Most Since life science quality and validation projects can vary widely in scope and complexity, each specific project needs to be evaluated in order to determine the resources and technical disciplines appropriate for anticipated tasks.

Following a period of experimentation, the life sciences industry is entering a pivotal new phase in its relationship with artificial intelligence.

Companies across the industry are operating in an increasingly complex environment; scientific innovation is accelerating, but regulatory scrutiny is intensifying across global markets. In this landscape, healthcare systems are under pressure to deliver better outcomes with constrained resources. At the same time, biopharma commercial models are evolving as engagement with healthcare professionals (HCPs) becomes more digital and data driven. Against this backdrop, AI is becoming a foundational capability required to operate effectively.

Over the past several years, AI has been tested across almost every step of the value chain, from molecule discovery and clinical trials to driving efficiencies in marketing and sales. The industry is shifting away from hypedriven pilots and toward proven, value-led applications that improve how therapies are developed, launched, and delivered to patients. What’s becoming clear is that the true differentiator won’t just be more algorithms, but how companies reimagine their people, processes, and data to unlock AI’s potential.

For life sciences companies, this will mean moving beyond AI as a bolt-on, pointfocused solution towards AI as an enabler of more connected operations. It will require rethinking how teams collaborate across R&D to commercial. It will also mean addressing long-standing structural challenges and silos that have historically limited the industry’s ability to move with precision and at speed.

As AI becomes more deeply embedded, this will determine whether organisations unlock sustainable value or simply add another layer of digital complexity.

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From commercial model transformation to clinical research acceleration, 2026 will be the year organisations embed AI into core operations with discipline and purpose. The following five predictions indicate how this shift will take shape across the entire life sciences value chain, and what it will take for the industry to move beyond experimentation to meaningful and measurable impact.

1. People and Process Change Will Drive AI Pivot to Value After years of widespread pilots with limited ROI, the life sciences industry will step back from an AI-at-all-costs approach.

Organisations will prioritise high-value AI use cases pointed at core operational and mission-critical processes and training people in new ways of working.

The right AI projects will drive noticeable efficiency and productivity gains, but most business value will come from focusing on people and processes that drive effective AI outcomes. For example, an AI agent that helps commercial teams quickly evaluate content for medical, legal and regulatory review will ensure accuracy, brand, and industry compliance to speed up reviews. But this agent will also free up highly trained industry experts to focus on higher-value work.

With a repeatable, targeted approach, organisations can set measurable goals based on business value, work with specific sets of operational users on AI adoption, adapt people and processes to new ways of working, and measure meaningful results.

2. Industry-Specific AI Will Orchestrate Commercial Connections Industry-specific AI, embedded in compliant and connected platforms and applications, will prove to be the critical component that unlocks coordination across sales, marketing, and medical activities. AI agents that have direct and secure access to data, content, and business processes will surface insights and connect workflows across teams with seamless omnichannel orchestration.

AI agents will keep the entire commercial team informed for more meaningful relationships with HCPs. For example, a field representative will record insights from

customer meetings through voice notes with ease as an AI agent simultaneously checks them for compliance. Another AI agent will automatically surface this information to the right field team members at the right time for better meeting planning and relationship management. AI can then be used to identify critical commercial themes and insights from the complete set of voice notes — a new and highly valuable dataset — to inform brand and go-to-market strategy.

These agentic AI capabilities will work together to support commercial teams in increasing productivity and delivering more effective and targeted customer engagement.

3. Industry Advances to More Agile, Dynamic Data for Launch Success The pace of launches is driving a shift toward more timely use of data, with processes catching up to daily access to data. A successful launch requires dynamic analytics and decision-making, like reallocating field resources when an HCP or territory is over or under planned treatment targets. This has created urgency for biopharmas and emerging biotechs to plan prompt actions from targeted data alerts and analytics rather than waiting for reports.

Smaller biotechs, whose survival depends on a new therapy going to market, are driving an agility that the wider industry will adopt.

For 2026, some companies will turn a 14day data analysis cycle into just 14 hours to activation. This is a big step forward from legacy weekly, monthly, or quarterly data, and a change that not only sets biopharmas up for launch success, but also enables better decision making for industry-specific AI. Real-time reallocations, especially during the first 18 months of a launch, will help get new medicine to the right patient, faster.

4. Agentic AI Lab Assistants Will Drive Connectivity and Speed Labs will move beyond simple chatbots to embed agentic lab assistants that connect highly specific tasks in a regulated environment. QC labs are turning their attention to the efficiency potential of AI agents and steering effort toward activating them across people and process. However, the technology ecosystems in QC labs are Spring 2026 Volume 18 Issue 1

Technology fragmented and paper-based processes persist. Companies will modernise and consolidate systems, standardise data and workflows, and integrate quality assurance to reap the productivity gains of QC-specific AI. Lab analysts will work alongside agents capable of starting workflows, summarising outcomes, and observing and analysing trends. This will advance proactive risk management by identifying issues early on and driving right first time execution.

The outcome will be a highly effective and efficient QC lab where people and agents work together to shorten batch cycle times.

5. Clinical Trial Data Flow Will Advance Recruitment and Improve Patient Access and Experience The flow of clinical data between sites and sponsors will yield faster, more efficient trials. Study information will go straight to physicians to connect their patients with relevant research. New embedded AI will connect trial data between sponsors and sites so that physicians can search treatment and trial options based on a patient’s conditions or test results. This direct-to-physician approach will reduce the industry’s reliance on sites to find study participants to meet recruitment goals sooner and improve patients’ access to clinical trials With less burden from patient recruitment requirements and modern technology, sites will see the promise of eliminating paper and manual source data verification (SDV) for clinical research associates (CRAs) become a reality. eSource tools will better connect upstream and downstream clinical data sources, first with EHRs so that patient health data can merge more efficiently with trial data. When connected with EDC, source forms will be defined by a trial definition so that data can flow faster, and with more clarity, to the sponsor. This data flow will streamline study visits for patients and advance trials for sites and sponsors.

Turning AI Ambition into Operational Impact AI is no longer an experimental technology sitting on the edges of the life sciences industry. It is rapidly becoming the connective tissue that links people, processes, and data across the entire development and commercial ecosystem. As the technology rapidly matures, the industry is starting to determine how to adopt AI to deliver real value while maintaining trust and scientific integrity. www.international-pharma.com

The organisations that will lead in 2026 won’t be the ones chasing the flashiest tools, but those making deliberate choices.

Success will come from focusing on highvalue use cases, preparing teams for new ways of working, and building the connected foundations that enable AI to operate safely, compliantly, and at scale. This approach requires discipline, an ability to step away from limited pilots, and commit to scalable solutions that can be integrated into everyday workflows.

The role of people will continue to remain central. As AI agents become more capable, their impact will depend on how well humans trust and collaborate with them. Leading life sciences companies are already investing in new skills, and redefining roles and processes to allow AI to augment, rather than replace, human expertise. This enables highly trained professionals in the field to focus on areas where human insight is most valuable.

The next era of innovation in life sciences will be defined not just by what AI can do, but by how intelligently and responsibly companies deploy it. Those who get this right will drive faster insights, smarter execution, and ultimately, better outcomes for patients.

This year, AI’s role in life sciences is clear: enabling connected, purpose-driven transformation across core industry functions. Organisations that build the right foundations today – through upskilling their people, redesigning core processes, and connecting data across R&D, clinical, and commercial operations – will shape the future of the industry and where it stands tomorrow.

Chris Moore Chris Moore joined Veeva in 2018 as President of Veeva Europe to enable the European team to establish Veeva as the cloud platform of choice for the Life Sciences industry for its R&D and Commercial activities. A 33-year veteran of the life sciences industry, Chris started his career at ICI Pharmaceuticals (now AstraZeneca). Chris holds a bachelor of science degree in information technology from the University of Salford.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 59

Logistics & Supply Chain

AI and Automation: The Secret to Faster and Safer Pharma Supply Chains The pharmaceutical industry is under unprecedented pressure. Shorter product lifecycles, increasingly complex therapies, stricter regulatory scrutiny and fragile global supply chains have combined to expose inefficiencies that were once tolerated as “the cost of doing business.”

At the same time, patients, regulators and commercial partners expect faster delivery and uncompromising safety.

In this environment, artificial intelligence (AI) and automation are becoming foundational capabilities for building pharmaceutical supply chains that are both resilient and responsive. Nowhere is this more apparent than in secondary packaging and late-stage supply chain operations, areas historically viewed as executional rather than strategic, but which increasingly determine speed to market, compliance outcomes and overall supply continuity.

This article explores how AI and automation are reshaping pharmaceutical supply chains, not as futuristic concepts, but as practical tools already delivering measurable gains in speed, safety and reliability.

From Bottleneck to Backbone: Reframing Secondary Packaging Secondary packaging sits at a critical junction in the pharmaceutical value chain. It is the point where drug product, regulatory compliance, supply chain orchestration and patient safety converge. Yet for decades, it has been characterised by labour-intensive processes, fragmented data and heavy reliance on manual decision-making.

Global supply chains, particularly for specialty pharma, biotech and niche branded products, are already long and complex. Any disruption at the packaging stage can cascade downstream, delaying market release or interrupting patient supply. As highlighted in recent industry discussions, shortening fulfilment cycles requires tighter integration between packaging operations and the broader supply chain, rather than treating packaging as a standalone activity.

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Automation has begun to change this dynamic By removing variability from repetitive tasks such as labelling, serialisation, aggregation and inspection, automated systems improve repeatability and consistency, which are two pillars of GMP compliance. More importantly, they free human expertise to focus on oversight, exception management and continuous improvement rather than manual execution.

detect manually. Current applications of AI in secondary packaging include:

Automation as a Quality Strategy, Not Just an Efficiency Play In pharmaceutical environments, speed is meaningless without control. One of the most significant contributions of automation is its ability to enhance quality while simultaneously improving throughput.

•

Automated packaging lines reduce the “human factor” in core processes, not by eliminating people, but by minimising opportunities for manual error in highly repetitive tasks. This is particularly relevant for activities such as serialisation and aggregation, where error rates have direct regulatory and financial consequences.

Automation ensures that each pack is treated consistently, every time, regardless of batch size or product complexity.

Crucially, automation also generates structured, high-quality data. Every movement, scan and verification step becomes a data point, creating a detailed digital audit trail.

This supports faster batch release, more robust deviation investigations and greater confidence during regulatory inspections.

Rather than viewing automation solely as a productivity tool, leading organisations increasingly treat it as a core component of their quality management strategy.

Where AI Enters the Equation While automation standardises execution, AI enhances decision-making. AI systems thrive in data-rich environments, and modern packaging operations generate vast volumes of operational data, from machine performance and line utilisation to material flow and schedule adherence. When applied effectively, AI can analyse these datasets to identify patterns that would be impossible to

• • •

Production scheduling optimisation, balancing capacity, changeover time and priority orders Predictive maintenance, identifying early indicators of equipment failure before downtime occurs Risk identification, flagging anomalies that could indicate quality or compliance issues Resource allocation, improving labour planning in hybrid automated-manual environments

Rather than replacing human judgment, AI augments it, providing decision support that enables teams to act faster and with greater confidence. As noted in industry briefings, these tools are increasingly embedded not only on the shop floor, but also across crosscompany workflows involving customers and material suppliers.

Exploring the Benefits of AI and Automation in Secondary Packaging As pharmaceutical supply chains become more complex and time-sensitive, secondary packaging is increasingly recognised as a strategic lever rather than a purely operational function. Advances in AI and automation are accelerating this shift, enabling packaging operations to move faster, operate more safely and integrate more seamlessly with the wider supply chain. From enhanced data visibility to smarter risk management, these technologies are redefining how value is created at the final stages of pharmaceutical production.

1. Data Visibility and Trust in the Supply Chain One of the most transformative yet often overlooked impacts of AI-enabled automation is its role in building trust across the supply chain. For specialty pharma and biotech companies, transparency is essential for managing small batches, fluctuating demand and regulatory complexity.

Digitised packaging environments generate continuous streams of structured data, which can be consolidated and shared through secure platforms. Near real-time Spring 2026 Volume 18 Issue 1

Logistics & Supply Chain visibility into production status, material availability and batch progress allows supply chain partners to move beyond periodic updates and manual reporting. Instead, stakeholders gain a shared, data-driven view of operations.

This level of transparency reduces friction, limits the need for escalation-driven communication and enables more informed decision-making. Crucially, it also supports deeper collaboration. When packaging partners are digitally embedded into their customers’ workflows, they can anticipate requirements, respond faster to change and operate as a true extension of the customer’s supply chain rather than as a transactional service provider.

2. Enabling Flexibility in a Small-Batch World The growth of personalised medicines, orphan drugs and advanced therapies has fundamentally altered the economics and expectations of pharmaceutical packaging.

Traditional high-volume models are increasingly ill-suited to a landscape defined by smaller batch sizes, frequent changeovers and diverse market-specific requirements.

AI and automation are key enablers of this new operating model. Automated packaging lines designed for rapid reconfiguration can support multiple products and formats without compromising efficiency or quality.

At the same time, AI-driven planning and scheduling tools can dynamically adapt to last-minute changes, urgent orders or material constraints, helping to maintain flow in an inherently variable environment.

This flexibility is particularly critical for emerging and mid-sized biopharma companies, which may lack the internal scale or infrastructure to manage such complexity on their own. Packaging partners equipped with intelligent systems are better positioned to absorb variability, manage uncertainty and protect timelines without transferring operational risk back to the client.

3. Safety, Compliance and Proactive Risk Management As regulatory scrutiny intensifies, pharmaceutical companies and their partners are under increasing pressure to demonstrate control, traceability and data integrity across outsourced operations. In this context, AI and automation are becoming central to modern compliance strategies.

AI-driven analytics enable a shift from reactive quality management to proactive www.international-pharma.com

risk mitigation. Machine learning (ML) models can detect subtle deviations in process performance or equipment behaviour long before they result in out-of-specification outcomes or batch failures. Early intervention reduces waste, prevents disruption and, most importantly, safeguards patient safety.

Automation further strengthens compliance by embedding traceability into every stage of the packaging process. Serialisation and aggregation systems ensure that each individual pack can be tracked throughout the supply chain, supporting recalls, anticounterfeiting measures and regulatory reporting. Together, AI and automation create a more resilient operational framework, one capable of maintaining compliance and continuity even in the face of disruption.

4. Smart Packaging: Promise Versus Reality Smart packaging technologies, including connected packs and dose-tracking systems, are often highlighted as the next major advance in patient safety and adherence monitoring. While their potential is widely acknowledged, real-world adoption in commercial pharmaceutical markets remains limited.

To date, demand for smart packaging has been concentrated largely in clinical trials and highly specialised products. Barriers such as cost, infrastructure complexity and unclear reimbursement models have slowed broader uptake, particularly for established commercial therapies.

However, the relevance of smart packaging should not be dismissed. The digital and data infrastructure being built today through AI-enabled automation provides a critical foundation for future adoption.

As technology matures and commercial drivers strengthen, organisations with robust digital capabilities will be best positioned to integrate smart packaging solutions quickly and at scale.

The Human Factor Still Matters Despite advances in AI and automation, people remain central to pharmaceutical supply chains. Technology can standardise processes and surface insights, but it cannot replace accountability, judgement or collaboration.

The most successful implementations treat AI as a tool to empower teams, reduce cognitive load, eliminate manual drudgery and enable professionals to focus on highervalue activities. This is particularly important

in environments where trust, responsiveness and partnership are key differentiators.

As niche and specialised service providers regain prominence, their ability to combine technological sophistication with humancentric service models may prove decisive.

Building the Intelligent Supply Chain The pharmaceutical supply chains of the future will be defined by how effectively multiple systems work together rather than by a single technology: • • •

Automation will continue to drive consistency and speed.

AI will increasingly orchestrate decisions across planning, execution and risk management.

Data will become the connective tissue linking partners across the value chain.

For organisations willing to invest in technology, integration, data quality and people, the payoff is significant: faster market access, safer products and supply chains that can withstand uncertainty rather than being derailed by it.

In an industry where patient outcomes depend on operational excellence, AI and automation are rapidly becoming the quiet enablers of trust, resilience and performance across the pharmaceutical supply chain.

Boy Tjoa Boy Tjoa, as Global Director of Engineering, leads the global engineering function, ensuring that facilities, equipment, and technical standards are optimised to support operational excellence and future growth. He is responsible for engineering performance across sites, including the setup and qualification of new packaging lines in the US facility, while ensuring compliance, reliability, and continuous technical improvement.

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2026’s Biggest Pharmaceutical Supply and Logistics Talking Points 2025 was a tumultuous year, riven with the consequences of global political instability, notably the looming threat, and implementation of, tariffs, alongside a number of high-profile patent cliffs, regulatory upheavals and cuts to longstanding funding.

The impact of tariffs in particular was at the heart of industry conversation, with the US seeing a 70% increase in medicine imports and a 493% increase in basic pharmaceutical product imports as a result, and certain estimates putting the potential cost per US household at $600 per year.1,2 From a supply chain and logistics point of view, diversification, and how it could help mitigate the impact of tariffs, was a subject of much debate.

Whilst exemptions were struck in the US, and manufacturing expansion mooted and confirmed, the EU progressed the Critical Medicines Act, including measures to incentivise supply chain diversification and boost resilience, further fuelling discussion around how global supply chains can best be protected from political instability as well as pandemics or natural disasters.

But, alongside the challenges of 2025 were serious successes and signs of progress.

Adoption of AI continued apace, with its application to drug discovery speeding development time and cutting costs. According to research from Mordor Intelligence, 95% of pharmaceutical companies are investing in AI capabilities, with the AI in Drug Discovery market size valued at USD 2.58 billion for 2025 and forecast to expand to USD 8.18 billion by 2030.3 All told, 2025 was a year of headlines for the pharmaceutical sector, and a year of challenges which were navigated with varying degrees of success. But, as we gather speed in 2026, what has changed and what has stayed the same? Which talking points are driving decision-making for the year ahead?

Below are three key subjects which we believe will unite the pharmaceutical community in shared discussion for 2026.

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Intelligent Futures Unsurprisingly, AI will remain a driving force across the pharmaceutical sector as we strive towards more intelligent and efficient ways of working. In 2026 we’re likely to see great strides forward, as the exploratory pilots of 2025 develop into agentic, autonomous systems that make operational decisions independently.

chain, to the proactive, how to optimise and decarbonise it.

For professionals in the pharmaceutical supply chain the question is how ethical AI frameworks can be used to drive innovation and transformation. At its simplest level, AI delivers efficiency through the automation of previously time-consuming manual activities, batch processing huge volumes of data or ensuring regulatory compliance across complex chains at speed. It can also be a valuable addition to procurement processes, analysing vast quantities of information to recommend smarter sourcing and transport options, optimising pallets, for example, and driving down costs.

Perhaps a more divisive topic when it comes to the future of agentic intelligence in pharma is its impact on the workforce. The question of how human skills combine with AI capability is not unique to our sector. In fact, a recent Government survey found that a third of the UK public fear that the evolving adoption of AI will put their job at risk, a fear which is perhaps not unfounded, given that a US based survey saw respondents predicting a 30 percent decrease in workforce as a result of AI.4,5

But beyond this, AI is increasingly being implemented as part of supply chain risk management strategies, analysing historic data to predict potential disruptions, optimising inventory levels and recommending production cadence in line with forecasted demand.

One area where this predictive technology is seeing strong adoption is in cold chain logistics. The sensitive nature of temperature-controlled shipments means the enhanced visibility and predictive capabilities of AI provide a game-changing new level of product assurance.

Intelligent data management is able to collate and analyse data from every shipment, assessing route performance, identifying regular deviations, monitoring thermal behaviour and more. This information can then be used to model shipments in advance, allowing for the identification of a wide range of potential supply chain disruptions, and providing recommendations on everything from the most suitable packaging solution to route adjustments in order to provide end-to-end assurance. As a result, the big questions around cold chain have shifted from the reactive, how to protect the cold

Ultimately, the utilisation of intelligent tools presents the opportunity to reduce waste, lower costs, improve reliability and – most importantly – protect product integrity from manufacturer to patient, making it a technology which is here to stay.

However, the efficiencies and savings offered by agentic solutions are undeniable, and emerging conversations centre on how the workforce can adapt to AI, rather than whether it is included at all. The future could look like reskilling for AI-driven roles, redefining which roles are needed or a reexamination of the importance of humanity in pharma, emotional intelligence and creativity, and how those capabilities impact a sector which functions to support and benefit human life.

This period of uncertainty, where the balance between man and machine has yet to be established, will doubtless give rise to much debate throughout 2026 and beyond, with the respective benefits of efficiency and financial savings weighed against the human factor in decision making.

Resilient Networks In the midst of so much uncertainty, from geopolitical shifts (tariffs, US administration instability) to cost volatility, the future of healthcare delivery and the vital importance of network resilience are likely to be top of mind for pharma professionals in 2026.

The geopolitical instability of recent years continues, with the navigation of tariffs, trade wars and regional conflict posing significant Spring 2026 Volume 18 Issue 1

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supply chain risk. Macro policy events have, of course, always had an impact on pharma networks, but the sliding balance of power between emerging drug developers like China and long-term onshoring goals pursued by the US and Europe have arguably resulted in a particularly challenging environment.

Another key topic on the subject of resilient networks is sustainability. Where once sustainability was seen as a compliance check box, it has become a strategic imperative and a core consideration in the design and management of pharma supply chains.

downstream return of medication and associated packaging still presents an enormous regulatory and logistical challenge, the increasing integration of reusable packaging into supply chains represents a positive step on the long road to broader value chain circularity.

For major pharmaceutical companies, nearshoring or reshoring presents an opportunity for greater protection against the volatility of global politics and tariffs, and incentives are being introduced to support this. As part of its Critical Medicines Act, the European Parliament is proposing to implement a Most Economically Advantageous Tender (MEAT) criteria, designed to favour companies where a significant proportion of production is located in the EU, whilst the US is offering a variety of reshoring incentives including the Reshoring Manufacturing Executive Order and the Inflation Reduction Act.

While ESG has recently experienced social and political ‘pushback’ in certain regions, it has, for many, evolved from a regulatory framework to a strategic tool. ESG data, for example, can indicate the reliability of a supplier and the likely risk of disruption or default due to sanctions related to health and safety or human rights.6

2026 will see several speaking events on the subject of circularity, with industry leaders such as GSK set to share comment on logistics sustainability, and the likes of CEVA hosting masterclasses on circular value chain, a testament to the emphasis being placed on these topics within the industry.

However, the question we’ll see in 2026 is how the resilience benefits of reshoring and nearshoring weigh against overall efficiency losses, and how supply networks as a whole will need to be structured as local manufacturing becomes more widely adopted. www.international-pharma.com

Similarly, circular value chains are now being considered in the context of wider business survival. The European Commission is working to incentivise circularity as a competitive differentiator, whilst Deloitte’s Circularity Gap Report 2025 positions circular solutions as the only clear way to meet growth and global sustainability targets whilst protecting network resilience.

Circularity reduces reliance on external suppliers and material extraction, both of which can be impacted by geopolitics and natural disasters. While the effective

Global Health Impact At the heart of pharmaceutical conversation, regardless of broader geopolitical challenges, is the unchanging focus on the sector’s overall impact on global health.

As a community, the objective is always to make access to medicines smarter, faster and fairer for patients. This aim is subject to many challenges, among these the obstacles presented by geopolitical uncertainty and access.

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concern. According to the International Pandemic Preparedness Secretariat (IPPS), global pandemic preparedness is becoming “increasingly fragile at a time of growing biosecurity and geopolitical risk”.7 And, while this applies globally, the question of equitable access was specifically highlighted by the IPPS. Following the G20 Health Ministers’ Meeting in November of last year, the Regionalized Vaccine Manufacturing Collaborative (RVMC) launched its first Status Report and Dashboard: Towards Regionalised Vaccine Manufacturing. Without access to advanced platforms and local clinical trials, the report notes, regions are unable to pivot quickly during outbreaks or meet routine immunization needs.

But, while RVM is a long-term goal on the roadmap to equitable access, the conversation around what can be done now remains active. For example, pharmaceutical industry collaboration between NGOs and non-profits remains a key factor in the support of healthcare for vulnerable populations, but how these partnerships are forged and maintain both ethical standards and transparency is a matter of debate.

Similarly, industry conversation around how supply chain innovation can support equitable healthcare delivery is ongoing. What 64 INTERNATIONAL PHARMACEUTICAL INDUSTRY

changes in terms of transport routes, supplier selection and production can be made to support globally accessible healthcare? What can we learn by soliciting external and nonpharma perspectives?

Collaborations such as that between Pfizer, Gavi and UNICEF provide insight into what can be achieved by humanitarian supply chains, and the 2026 pharma event calendar offers opportunities to learn from partnerships such as these.

As we progress into what is almost certainly going to be yet another year of challenge and change for the industry, almost nothing is guaranteed. However, as a community, the focus remains upon what matters most, delivering for patients. In terms of how we achieve this, there are no set parameters, but for 2026, a strong focus on intelligent futures, resilient networks and global health impact will provide a strong foundation for creating meaningful change. As ever, collaboration and communication will enable the pharma industry to evolve, and it is by having crucial, and often difficult, conversations that this will be achieved.

REFERENCES 1.

2.

https://www.exportplanning.com/en/magazine/ article/2025/05/14/us-imports-in-q1-2025-goldpharmaceuticals-and-technology-lead-the-surge/ https://pmc.ncbi.nlm.nih.gov/articles/

3.

4.

5.

6.

7.

PMC12123191/#:~:text=of%20public%20welfare.,2,health%20care%20system%20and%20patients. https://www.mordorintelligence.com/industryreports/artificial-intelligence-in-drug-discoverymarket https://www.ons.gov.uk/aboutus/ transparencyandgovernance/freedomof informationfoi/researchintohow artificialintelligenceaiisaffectingemployment https://www.mckinsey.com/capabilities/ quantumblack/our-insights/the-state-of-ai https://mygreenlab.org/the-beaker-blog/howbiotech-pharma-are-advancing-climate-actionamid-esg-headwinds/#:~:text=On%20the%20 one%20hand%2C%20this,%2C%20and%20 company%2Dlevel%20progress. https://healthpolicy-watch.news/geopolitical-riskis-undermining-global-pandemic-preparedness/

Ben Sharples Ben Sharples is a seasoned professional with extensive experience in event management and business strategy.

Currently serving as event director for LogiPharma, Ben aims to facilitate industrycritical conversations for pharmaceutical professionals at this year's event, increasing the level of interactivity featured within the 2026 agenda and prioritising attendee engagement.

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www.international-pharma.com

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High Stakes, Higher Standards: Air Cargo and Pharma Integrity Pharmaceutical logistics has long been recognised as one of the most technically demanding areas of global supply chain management. Precision, credible temperature control and consistent reliability are central to the movement of medicines. In recent years the level of scrutiny and expectation has increased, driven by new therapeutic categories, ongoing geopolitical disruption and more stringent regulatory oversight.

Air cargo plays a vital role in this environment. For medicines that require rapid movement, precise temperature management or intercontinental transit, air transport remains the most dependable means of maintaining the conditions these medicines demand. The advancement of pharmaceutical logistics is shaped by developments across manufacturing, regulation, global trade and cold chain capability. Understanding these dynamics requires looking across the ecosystem, rather than focusing on any single organisation including from the perspective of an airline cargo operator handling temperature sensitive pharmaceuticals.

These developments are accompanied by ongoing changes in regulatory expectations.

Requirements for real time monitoring, chain of custody transparency and digital traceability have intensified. In parallel, Good Distribution Practice guidelines continue to anchor quality expectations across many regions. Together, these frameworks highlight the sector’s move towards continuous visibility and operational accountability.

These developments show that the pharmaceutical industry is deepening its reliance on cold chain systems and that the movement of products will demand increasingly precise handling. This places significant responsibility on logistics operators, infrastructure providers and supply chain partners. The stakes are high and increasing.

Why Air Transport Remains Vital Air transport plays a distinct role in pharmaceutical logistics, offering the speed and control required for temperature sensitive products. For items with short stability periods or long-distance time constraints, it provides a level of reliability that other modes cannot match. Longer transits increase exposure to

temperature excursions, and each transfer or delay raises the risk of deviation for sensitive products.

The pharmaceutical logistics environment is becoming more demanding, with geopolitical uncertainty, regulatory change and expectations around shipment visibility all increasing operational pressure. In this context, transport solutions must be able to adapt to changing conditions while preserving oversight across the cold chain.

Nearly twenty percent of new drugs under development are cell or gene-based therapies, and these often require narrow temperature ranges and rapid movement between production sites, clinical facilities and distribution centres. Their growing presence strengthens demand for reliable, long-distance, temperature-controlled transport.

Cold Chain Pressures and the Need for Operational Certainty Cold chain handling has always required careful control, but the growth of specialised medicines has increased expectations across the supply chain. Temperature excursions

A Changing Pharmaceutical Landscape Global pharmaceutical supply chains are in a period of sustained transformation.

The volume of temperature-controlled medicines moving through air freight has expanded steadily in recent years, reflecting the growing prominence of biologics, vaccines and other highly sensitive therapies that depend on tightly managed transport conditions. This shift is less about absolute scale than about complexity: more products now require narrower temperature tolerances, greater monitoring and more coordinated handling across international supply chains.

A wider market view reaffirms this trend, with the global healthcare cold chain logistics market value anticipated to rise from about 62.5 billion USD in 2025 to a projected 95.1 billion USD by 2030. Growth on this scale is fuelled by the rising demand for biologics and personalised medicines, which are significantly more temperature sensitive than many traditional pharmaceuticals.

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Spring 2026 Volume 18 Issue 1

Logistics & Supply Chain remain one of the most significant risks in pharmaceutical logistics, as even a brief deviation can cause irreversible damage. This risk is heightened by the complexity of global supply chains, the number of stakeholders involved and the increasing regulatory focus on documentation and traceability.

Facilities with direct airside access and dedicated cool cell storage offer additional protection by reducing exposure to external temperatures during loading and unloading.

These considerations are particularly important for products with narrow stability ranges.

The rising share of biologics, mRNA vaccines and cell therapies means that cold chain logistics is now treated as a strategic priority across the pharmaceutical sector. Companies are investing in real time temperature tracking, connected sensor technology and more advanced packaging to minimise exposure to variable conditions during transit. These investments represent an industry-wide recognition that reliance on manual controls or fragmented monitoring is no longer sufficient.

Automation is becoming more prominent in pharmaceutical handling. Material handling systems support consistent cargo flow, regulate dwell times and enable accurate allocation and storage. These technologies reduce the risk of errors associated with manual processes and help maintain the level of predictability required in a high demand cold chain environment.

Digital technologies are reshaping expectations across pharmaceutical logistics.

In a recent global survey of logistics decision makers, eighty-eight percent of respondents in the pharmaceutical and healthcare sector identified Internet of Things devices as a critical trend, while eighty-six percent emphasised supply chain visibility.4 The findings illustrate the value placed on continuous monitoring and the need to understand conditions at every stage of a shipment’s journey.

As a result, integrated digital systems are becoming essential for both product safety and regulatory compliance.

Another critical element is the development of resilient global networks supported by trained specialists. The complexity of international pharmaceutical movements requires expertise in documentation, regulatory expectations and route planning.

Having experienced personnel available across multiple regions, helps ensure that deviations, disruptions, or unexpected events are managed quickly and effectively.

Collectively, these developments signal where pharmaceutical air logistics is moving, with reliability, transparency and resilience supported by modern facilities, technology and skilled personnel.

High performing facilities, trained personnel and reliable temperaturecontrolled infrastructure are central to maintaining product integrity. As pharmaceutical supply chains become more advanced, logistics providers must ensure their operations reflect the sensitivity of the goods in their care.

The Future of Pharmaceutical Air Logistics The next phase of pharmaceutical logistics will be shaped by several trends already visible across the industry. Digital transformation is one of the most significant and organisations are increasingly turning to automation to support route planning, demand forecasting and predictive maintenance for temperaturecontrolled assets.

Lessons From Operational Experience To understand how pharmaceutical logistics is meeting these rising demands, it is helpful to look at developments within the air cargo sector. Appropriate handling relies on suitable infrastructure, and recent years have seen greater investment in temperature-controlled facilities to meet rising requirements.

Cold chain excellence will continue to be a central priority and cargo companies will continue to invest more in real time visibility tools, improved insulation technologies and advanced packaging solutions that provide greater stability for sensitive materials. The fact is that product quality is only maintained when the cold chain performs consistently.

Purpose built facilities have become essential for meeting modern pharmaceutical standards. High specification temperaturecontrolled buildings, equipped with multi zone storage environments, advanced monitoring systems and streamlined processes, help reduce risks associated with manual handling or unregulated conditions.

Regulation is another constant factor that will continue to influence pharmaceutical logistics. With new traceability requirements and evolving quality standards emerging across multiple jurisdictions, logistics providers and other supply chain operators will need to maintain flexibility in their processes. Integrated digital systems,

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audit ready documentation and validated equipment will be essential to support compliance and maintain the confidence of regulators and customers.

Resilience has moved beyond contingency plans. It requires flexible networks, backup routes and strong partnerships to keep products moving during geopolitical, weather or demand driven disruption. Diversifying supply chains is now a key part of managing these risks.

When infrastructure, skills and technology are aligned with product requirements, handling becomes more dependable. Air transport continues to play a central role, offering the speed and temperature control needed for essential medicines.

Safeguarding Medicines, Now and Next Pharmaceutical logistics is changing, with new therapies, tighter regulation and a more volatile operating environment raising expectations for accuracy, transparency and resilience. Air transport provides the speed and predictability needed to move medicines safely. Across the sector, purpose‑built facilities, automation and digital monitoring are strengthening cold chain performance and visibility.

Delivering safely depends on precise operations and effective collaboration. In this environment, being trusted to deliver means consistent control, dependable uplift and proven care for temperature‑sensitive products, supported by a network that connects major pharmaceutical markets worldwide.

REFERENCES 1.

2.

3.

4.

https://www.mordorintelligence.com/industryreports/healthcare-cold-chain-logistics-market https://www.tempcontrolpack.com/knowledge/ 2025-pharma-cold-chain-logistics-trendssolutions/ https://www.bolderscg.com/navigating-pharmalogistics-in-2025-trends-challenges-and-smartsolutions/ https://www.maersk.com/insights/integratedlogistics/2025/09/26/exploring-top-trends-inpharma-and-healthcare-industry

Jordan Kohlbeck Jordan Kohlbeck is Head of Pharmaceutical, IAG Cargo.

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Why Thermal Assurance Is the Key to a Resilient Cold Chain The secure delivery of temperaturecontrolled shipments has evolved drastically in recent years, especially in regard to visibility that products are not compromised during transit. But, within that same period of time we’ve seen greater challenges to the cold chain emerge.

From a geopolitical perspective, trade wars and tariffs have caused delays and difficulties, whilst regulatory challenges, for example the still-lingering consequences of Brexit, have weakened some regional cold chain infrastructures.

With major pharma producing regions such as the EU and US striving for greater resilience, the upheaval of reshoring and nearshoring is another recent complication to long term cold chain planning.

Alongside the impact of manufacturing relocation, economic sanctions and regulatory restrictions, are the ongoing complexities of navigating conflict-affected regions which may have limited cold storage facilities, damaged transport networks and complex access processes, further complicating the construction of a resilient distribution network.

Intensifying environmental pressures are also adding strain, both in terms of the pursuit of sustainability goals and the realworld impact of climate change. Whilst the industry is making great strides in reducing carbon emissions across Scope 1 and 2, Scope 3 emissions (those most relevant to supply chain) still account for 80–90% of the pharmaceutical sector’s total climate impact.

The responsible specification of cold chain packaging is also under scrutiny, with The World Health Organisation’s (WHO) Guidelines for the International Packaging and Shipping of Vaccines (2025), for example, placing a clear emphasis on the role of reusable, sustainable packaging.

Meanwhile, the impact of environmental neglect in decades past is manifesting today as growing incidents of extreme weather.

The number of weather-related disasters has increased by a factor of five over the 68 INTERNATIONAL PHARMACEUTICAL INDUSTRY

past 50 years, with extreme rainfall events increasing globally, and a growing frequency of tropical cyclones in historically uncommon locations.1,2,3 Add in the yet to be defined role of AI, its impact on the workforce and potential vulnerability to cyber-attack and the result is a highly charged landscape in which cold chain resilience is of paramount importance.

Where once the response to these challenges was reactive, focused on how to protect the cold chain and how to minimise the impact of incidents, the current landscape demands proactivity, and a fully realised ecosystem with thermal assurance at its heart. This means combining best-in-class product solutions, emerging and established technology, and human expertise to create an end-to-end strategy that goes beyond shipment integrity and into broader network resilience.

Specification and Route Qualification Comprehensive thermal assurance, meaning a strategic approach to robust and resilient cold chain logistics, begins with expert packaging consultancy and a data-driven approach to route planning.

The greatest challenge for cold chain logistics historically has been visibility. The basics of where a shipment is and whether it’s on track as the first layer of information, then evolving to reporting disruptions or incursions in transit, to today, where realtime data can indicate the risk of temperature fluctuation and inform risk scores, along with product testing and knowledge.

Basic digital insight, such as track and trace, is now effectively standard within the industry. But what can more advanced and emerging technology offer in terms of actionable insights, and how does this contribute to end-to-end thermal assurance?

One of the most critical tools is thermal modelling. In terms of its use in packaging specification, thermal modelling has become a central factor in determining the selection of packaging type and pack out per shipment, using qualified data points to ensure the most

efficient and reliable solution is selected each time.

High level providers now offer customised insulated shipping systems which are not only specified in-line with laboratory and real-world data, but which can be tailored to specific operational and regulatory needs.

This, alongside the ability to customise pack outs in-line with product needs, means that every element of packaging can be optimised for the greatest level of assurance.

Furthermore, this forensic approach to packaging selection allows for ongoing optimisation and right-sized solutions for each shipment, providing financial and environmental benefits.

Modelling technology, powered by ambient data as gathered by shipment sensors, also offers an enhanced level of risk management, predicting thermal behaviour and temperature mapping complex supply chains to provide quantified recommendations. This can include utilising data on which regions may have infrastructure challenges which pose a risk to temperature control, which ports or airports have a pattern of delays in customs procedures, or risks of extreme weather, allowing for contingencies to be built into a route ahead of time.

Similarly, ambient data modelling can provide initial lane qualification, using historic and real-time data to flag the potential environmental, logistical and regulatory risks of a given route. This detailed insight and predictive analysis, alongside technical advice from a trusted provider, allows for the creation of a data-informed cold chain shipment that has been risk assessed at every level and developed with contingencies in place for pre-identified challenges within the supply chain.

This approach, which takes the process of packaging and route selection to a granular level, represents a strategic shift in how cold chain shipments are managed, moving from basic temperature monitoring to comprehensive thermal assurance.

From a sustainability point of view, high performance reusable packaging provides the opportunity to balance the importance of Spring 2026 Volume 18 Issue 1

Logistics & Supply Chain robust packaging and real-time monitoring with a contribution towards sustainability targets. Options which can be leased offer a lower-cost-per-use reusable solution which can dramatically reduce storage requirements, whilst also delivering a fossil fuel use reduction. These environmentally shippers are available with support through return and redeployment via tracking, and certain providers also include tools to track landfill avoidance for enhanced ESG reporting.

Actionable Insight, Human Oversight While data is critical to packaging selection and route qualification, it extends far beyond these elements.

Today real-time monitoring is now integrated into the majority of cold chain networks to a greater or lesser extent. But the scope of that data, and the ways in which it is used, make a big difference to how a cold chain can be protected, maintained and optimised.

In terms of providing a true picture of a shipment’s thermal assurance, end to end visibility is essential.

supplier should be able to provide regional assistance, combining their knowledge of local regulatory considerations with insights from both previous shipments and the one in progress.

Aside from how this level of monitoring can be used retroactively, the real-time visibility offered by end-to-end tracking provides the opportunity for proactive risk management mid-shipment. This proactivity is where the human element to thermal assurance becomes critical. Where technology is able to identify patterns to predict possible risk, and where data can be used to qualify future routes, the navigation of a critical situation as it unfolds requires the intervention of an experienced cold chain logistics expert.

Advanced thermal assurance ecosystems incorporate a mix of technologies, from monitoring tools to modelling systems, along with a strong network of specialised technical advisors to consult before, during and after a shipment. For those supplying product globally via cold chain networks, the ability to access neutral, context-driven guidance around packaging selection, risk management, regulatory compliance and thermal strategy, as well as digital insights, is critical to thermal assurance.

Access to a global network of expertise, in conjunction to data-driven insights, allows for the quick and effective resolution, or total avoidance, of mid-shipment incidents. Instant data sharing means that wherever a shipment has encountered difficulty, your partner

Optimisation Outside of risk management, data modelling and the insights generated as a result can also contribute to cost efficiencies and route optimisation. Intelligent systems can digest huge volumes of information, looking for patterns or gaps and assessing where refinements to existing processes can be made. Operational analysis which would once have taken weeks and months can be done in minutes or hours, allowing for ongoing refinements to the cold chain, driving further robustness and resilience.

By applying these actionable insights to every element of the cold chain, companies can identify opportunities to reduce waste, lower costs and improve reliability, contributing to an increasingly more impregnable thermal assurance strategy.

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Ultimately, safe, effective and efficient cold chain management is only part of the broader picture of thermal assurance.

Companies using temperature-controlled shipping should now be seeking strategic partners which are able to combine proven thermal solutions, next generation digital intelligence and a global network of human expertise to deliver not only reliability but optimisation, reducing risk, lowering costs and increase sustainability.

REFERENCES 1.

2.

3.

https://wmo.int/topics/extreme-weather https://theconversation.com/what-is-theglobal-water-cycle-and-how-is-it-amplifyingclimate-disasters-272806 https://theconversation.com/what-is-theglobal-water-cycle-and-how-is-it-amplifyingclimate-disasters-272806

Luiza Cervetto Luiza Cervetto, Senior Global Strategy and Product Manager, Cold Chain Technologies. With over twelve years’ experience in strategy and product management, Luiza co-ordinates multifunctional teams across Cold Chain Technologies with a view to solving customer challenges and delivering end-to-end thermal assurance for pharmaceutical businesses globally.

INTERNATIONAL PHARMACEUTICAL INDUSTRY 69

LABORATORY FOR ANALYSIS AND STABILITY TESTING

Precision in Inhalation Confidence in Every Dose ADVANCED ANALYTICAL TESTING FOR INHALED DRUG PRODUCTS Fully compliant with cGMP and ICH guidelines; 30 years experience as GMP-certified lab From development studies to market release Extended Storage at ICH-conditions

OUR INHALATION TESTING CAPABILITIES INCLUDE: MDI • DPI • Nebulizers • Nasal Including advanced modalities (e.g. mRNA, viral vectors) Method development • Validation service Routine testing • Release testing

l nica h c e rT h at ou shop wit ber, s u t cto Mee ion Work –8 O 7 t a c l i ntif Inha Scie y e l ny on) Cop erma ening so G , z Main ration op ist (Reg

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Subsection:

Nasal and Pulmonary

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L E T ’S B U I L D T H E FUTURE TOGETHER We M a k e I n h a l e r s .

Merxin Ltd specialises in designing and supplying inhaler devices, including dry powder and soft mist inhalers, for evaluation through to commercial supply. Our expertise spans therapeutic categories, from biologics and small molecules to generic and novel therapies.

W e W i l l L a u n c h Yo u .

O u r D N A i s i n t h e p h a r m a i n d u s t r y . We a re c o m m i t t e d t o d e l i v e r i n g q u a l i t y , reliability, and efficacy. Our reputation is built on excellence.

Make It Better.

We a re c e r t i f i e d a s m e e t i n g t h e re q u i re m e n t s o f I S O 1 3 4 8 5 : 2 0 1 6 f o r t h e Design, Development, and Supply of inhalers. Our goal is to improve your molecule’s efficacy and improve patient outcomes worldwide.

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info@merxin.com

Spring 2026 Volume 18 Issue 1

Nasal and Pulmonary

The Role of Inhaled Therapies in the Fight Against Respiratory Syncytial Virus (RSV) In Short: • • • • •

The market for RSV therapies could grow to $7.2 billion by 2030.

There were 218 drugs in development for the treatment of RSV in November 2025.

Most therapies are at the pre-clinical stage, 17 in Phase I-III and 3 with IND/ CTA filed.

Vaccines, proteins and antibodies are the leading molecule types.

Inhaled RSV therapies are emerging as attractive options, with soft mist inhalers such as MRX004 poised for a meaningful share of the market.

Respiratory Syncytial Virus (RSV) is a common viral infection typically causing coldlike symptoms. By the age of two, almost all children are believed to have contracted RSV, with the virus affecting around 64 million individuals globally every year.1 Symptoms are mild in most cases but can become severe for babies, infants and certain adults at high risk, including older adults or those with chronic lung or heart disease. In such cases, the virus can worsen asthma or chronic obstructive pulmonary disease (COPD) symptoms and lead to further life-threatening infections such as pneumonia and bronchiolitis.

According to the World Health Organization, RSV causes more than 3.6 million hospitalisations and approximately 100,000 deaths in children aged under five each year.2 Hospitalisation rates are highest in infants under six months or those who are born preterm or with a low birth weight. According to a report by the UK Government, RSV infections are responsible for up to 80% of lower respiratory tract infections in young children and are one of the leading causes of hospitalisation in the first year of life.3 Meanwhile, yearly estimates for the US alone stand at 110,000 to 180,000 hospitalisations for individuals aged 50 or above.4 Marketed Drug Landscape Unmet therapeutic needs for RSV infections are significant. While the pathogen was first identified in 1956, vaccine developments has faced significant setbacks, with early www.international-pharma.com

candidates worsening illness severity and leading to two infants’ deaths. Following these outcomes, research was halted for many years.

Between 1998 and 2023, just one monoclonal antibody was used to prevent infections via passive immunisation. SYNAGIS ® (palivizumab) was reserved for at-risk pre-term infants, requiring five intramuscular injections over the course of a single RSV season due to its short half-life. This dosing schedule created a logistical burden for parents, while the uncomfortable delivery format could cause potential distress for babies and parents. SYNAGIS® was discontinued and unavailable from 31 Dec 2025.

commenced in England in September 2024.5 In light of these changing tides, it is forecasted that the RSV prophylaxis market could grow from $582 million in 2020 to $7.2 billion by 2030, reflecting a compound annual growth rate of 28.6%.

The numbers of clinical trials commencing in this area each year is also soaring, reaching an all-time peak in 2024 and growing 138% between 2016 and 2025. Accordingly, there were 218 RSV drugs in development

by November 2025, 50% of these were prophylactic vaccines. The majority of which are delivered by injection. The second largest category is inhaled drugs, accounting for a third of the pipeline. (see Figure 1)

In 2023, things began to look up. A singledose, long-lasting monoclonal antibody (mAb) was approved for babies and infants in their first RSV season, and the first prophylactic vaccines for adult RSV hit the market, starting with GSK’s AREXVY ® for over 60-year-olds and at-risk individuals aged 50 to 59. Not long after, Pfizer introduced ABRYSMO® for at-risk adults aged 18–59 and pregnant individuals between 32 and 36 weeks gestation, providing a unique form of protection for newborn babies in their crucial early months. This was followed

by Moderna’s mRESVIA® launch for at-risk 18–59-year-olds.

Exploring the Potential Behind Inhaled Therapies RSV infects the airway epithelium, releasing new virus particles into the airway mucus as the virus replicates. With infections confined to the airways, pulmonary or nasal inhaled delivery could potentially offer a more effective pathway for treating and preventing the RSV infections. As most inhaled drugs being developed for delivery via nasal spray/ drops or hand-held nebuliser, and even a few via dry powder inhaler devices, inhaled therapies pave the way for easy, at-home treatments and vaccinations which could be used during virus outbreaks.

After decades of no or slow progress, new products have driven increased public awareness and government-sponsored immunisation campaigns, the first of which

There are currently just two inhaled molecules for RSV treatment on the global market, including interferon alfa, a recombinant protein nasal spray marketed in

Figure 1: RSV pipeline by route of administration INTERNATIONAL PHARMACEUTICAL INDUSTRY 73

Nasal and Pulmonary Russia, and aerosolised ribavirin (VIRAZOLE®), a synthetic nucleoside with antiviral activity.

Originally in an oral dosage form, Ribavirin was first approved in 1968 for infants and young children hospitalised with severe lower respiratory tract infections caused by RSV. It has since been formulated as a powder for solution, inhaled via nebuliser, and is currently marketed in Canada, Mexico, Australia, and Russia. VIRAZOLE® was recently discontinued in other markets, though generic versions are available in the US and China.

It is clearly early days for inhaled RSV therapies but the inhaled route is gaining some traction. As shown in Figure 2, most of the therapies are in the preclinical stage of development, but there are 17 in Phases I-III as well as three with an IND/CTA filed.

Meanwhile, when looking at the pipeline by molecule types (Figure 3), vaccines, proteins, and antibodies are the clear frontrunners.

Figure 2: Number of inhaled RSV programmes per development stage

Intranasal vaccines for RSV Vaccines make up 25 of the inhaled therapies in active development for RSV, which represents more than half of the pipeline.

In addition, almost all of these candidates have been formulated for nasal delivery. Most of the vaccines are being developed in the United States (Figure 4).

Until recently, the leader had been Sanofi’s intranasal live attenuated vaccine (LAV), SP0125, which was being evaluated in infants in a Phase III study scheduled for completion in 2027. However, in October 2025, Sanofi revealed it was terminating the trial due to efficacy limitations.

In the LAV category, a number of vaccines are being developed at the National Institute of Allergy and Infectious Diseases headquartered in Maryland, USA. These include three Phase II nasal drop vaccines for preventing RSV infections, as well as a further three products in Phase I development.

Within the recombinant vector vaccine group, a BLB-201 is being progressed through Phase I/II trials, with completion expected in December 2026. BLB-201 is a paediatric intranasal recombinant vector vaccine developed on the parainfluenza virus 5 platform. In December 2024, promising interim results from the study were published, with data from the first 63 participants suggesting that those who received the vaccine were more than 80% less likely to contract symptomatic RSV infections than participants who received placebo.

74 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Figure 3: Number of inhaled RSV programmes per molecule type

Figure 4: Number of inhaled RSV vaccine pipeline by location of sponsor company's headquarters

Other vaccine categories showing potential for inhaled delivery include subunit vaccines and mRNA vaccines. The mRNA space is dominated by an innovative nanoparticles platform to develop intranasal vaccines for RSV. In the subunit vaccine category, meanwhile, another interesting product stands out. It is an inhalable powder of virus-like particles, which mimic the native viruses, without containing any viral genetic material. With simple self-administration and no need for cold chain infrastructure,

it is believed that inhaled powder vaccines for RSV not only offer the “best route of immunisation” via the mucosal surface but could also increase patient acceptance, extend product shelf life, and offer easier distribution, making them valuable tools in the event of an emerging epidemic.

Inhalable Proteins for RSV Beyond vaccines, other key therapies include recombinant proteins and monoclonal antibodies. One protein in particular, interferon, has come to the fore across a wide range of infectious diseases for its broadSpring 2026 Volume 18 Issue 1

Nasal and Pulmonary gaining momentum, with new vaccines, longer-lasting monoclonal antibodies, and even a wider range of antivirals now starting to close the treatment gap and prevent the infection in at-risk individuals. There is still a way to go, however, with no paediatric vaccines yet available.

As innovation takes off, inhaled drug delivery is emerging as an attractive option for its ability to deliver potent agents directly to the lungs. As the pipeline of nebulised therapies advances, these aerosolised formulations have the potential to be converted into more convenient, user-friendly devices such as the MRX004 soft mist inhaler.

Meanwhile, if companies can overcome the stability challenges that lie ahead, dry powder inhaler-based delivery could come to the fore, with devices such as the MRX003 and MRX006 further accelerating innovation in this growing space.

REFERENCES

MRX002+ (HFA pMDi see-through vial)

MRX004 (Soft Mist Inhaler)

spectrum antiviral and immune-modulatory effects. In RSV, an inhaled interferon-alpha1b protein was in active Phase III trials in 2024, was awarded a Breakthrough Therapy designation, and had an IND approved, enabling clinical trials to commence.

during the API development, opening the doors to more user-friendly formulations. The molecule is designed for administration via a dry powder inhaler, offering easy storage, simple administration, portability, and accessibility.

UK-based Synairgen is investigating its lead asset SNG001, inhaled interferon-beta, in a large Phase II trial. Initiated in September 2025, the INVENT study investigates SNG001 in mechanically ventilated patients with severe viral lung infections including RSV. Earlier this year, Synairgen raised £18 million to fund the Phase II trial.

Competition could also come from a Phase I trial for an interferon-beta in RSV, COVID-19, and influenza in development by another company.

Groundbreaking bioprocessing advancements have overcome traditional stability challenges

Meanwhile, another company is currently exploring its lead asset based on a sialic acid-binding protein, in a wide range of respiratory viruses. Delivered intranasally, it binds to sialic acids on host cells in the nose, blocking the entry of viral cells to the respiratory system. It is currently in preclinical development for RSV and is also showing promise in Influenza A. A Future of Innovation Lies Ahead After a disastrous start, followed by decades of inactivity, RSV drug development is finally

1.

2.

3.

4.

5.

https://www.heart.org/en/health-topics/rsv https://www.who.int/news-room/fact-sheets/ detail/respiratory-syncytial-virus-(rsv) https://www.england.nhs.uk/south/wp-content/ uploads/sites/6/2021/07/phe-ref-ra-21.035palivizumab-passive-immunisationagainstrespiratory-syncytial-virus-rsv-in-at-risk-preterm.pdf https://www.cdc.gov/rsv/adults/index.html https://www.infectionpreventioncontrol. net/uk-launches-worlds-first-national-rsvvaccination-program/

Philippe Rogueda Philippe co-founded Merxin Ltd in 2015. His expertise spans across multiple facets of the inhalation field, particularly with dry powder and soft mist inhalers. Philippe’s passion lies in the development of soft mist inhaler technology, particularly for biologics, which he believes holds immense potential to revolutionise the delivery of inhaled therapies. With over a decade of experience in the inhalation sector, Philippe’s deep knowledge and innovative approach to inhalation technologies make him a key figure in advancing medical device development for improved drug delivery systems.

Merxin Ltd WE MAKE INHALERS

MRX003 (Capsule Dry Powder Inhaler) www.international-pharma.com

MRX006 (Multidose Dry Powder Inhaler) INTERNATIONAL PHARMACEUTICAL INDUSTRY 75

Nasal and Pulmonary

Facility Spotlight: Device design and development at King’s Lynn The inhalation industry is evolving.

Advances in in silico and AI-based technologies, sustainability drivers, and a changing regulatory landscape are collectively moving the goalposts for device design and development.

Against this backdrop, specialist contract development and manufacturing organisations (CDMOs) such as Bespak are in a unique position to get ahead of the curve by adopting the latest technologies to support their customers.

We sat down with key thought leaders at Bespak to discuss inhalation device design and development capabilities at Bespak’s King’s Lynn site in Norfolk, UK and how these have evolved to meet industry needs. In this deep dive, we gathered insights from: Shaun Williams, Product Engineering Manager, Karl Bass, Principal Model-Based Systems Engineer, Tony Mallett, Platform Development Group Manager, and Thomas Daly, Development Engineer, at Bespak.

Please can you tell us about your services at King’s Lynn?

Tony Mallett (TM): At King’s Lynn, we are a one stop shop for holistic device design and development. From early-stage testing to quality assurance (QA), our engineers can rapidly progress inhalation devices toward commercialisation in our validated development lab. Meanwhile, Bespak’s polymer lab provides an excellent understanding of material characterisation that can feed into rapid prototyping. But it’s not just about capabilities; it’s about how you use them. A major focus for us right now is cutting down on the amount of time needed to get from, say, “stage A” to “stage C” or “D”. That’s where concept feasibility comes in, leveraging device design understanding to allow products to progress to clinical trials more quickly and with reduced testing needs.

Shaun Williams (SW): We also offer cuttingedge in-house simulation capabilities, which are supported by a high-performance 76 INTERNATIONAL PHARMACEUTICAL INDUSTRY

computer cluster that can run simulations rapidly. Our team offers rapid prototyping, functional testing, toolroom manufacturing, QC, and analytical labs. At the same time, our award-winning Injection Moulding Academy helps to keep standards high in device manufacturing. Here, we offer unique apprenticeships for polymer technicians and in-depth training programmes for engineers transitioning from other industries. Sharing skills in-house in this way enables the business to quickly adapt to new industry demands and trends, ensuring Bespak remains at the forefront.

Which key industry trends have impacted your device design & development work at King’s Lynn?

TM: The biggest industry trend from a pressurised Metered Dose Inhaler (pMDI) point of view is ensuring effectiveness as the industry transitions to next-generation propellants with a lower Global Warming Potential (GWP). Materials innovation, such as the use of greener materials in inhalation devices, is another area that I am excited about.

Karl Bass (KB): From my perspective, modelbased systems engineering, which involves using digital models as the primary source of truth for designing, analysing, and verifying complex systems, is an important and growing trend. In a similar vein, virtual simulation is something that I believe holds enormous promise. While this technology has been used predominantly in product development, at Bespak we are working to expand the use of virtual simulation into other areas as well – such as formulation development and in silico clinical trials.

Thomas Daly (TD): Simulation is certainly at the forefront of the industry. There is a clear movement toward more in silico simulationdriven approaches to solve challenging engineering problems and identify optimal solutions, which are then supported with validated experimental data.

SW: I would also say that sustainability is another key driver in the industry right now.

Environmental awareness and regulatory changes are fuelling the transition to low

carbon pMDIs as well as efforts to reduce waste and enhance material selection. As part of that, we are seeing a need to optimise or develop tools that can allow us and our customers to become more sustainable.

Advances in in silico technology are making an impact here too, supporting fewer clinical trials, reduced API usage, improved material selection, and an increased use of digital engineering that can reduce the reliance on physical experimentation.

Can you tell us more about how Bespak is making use of AI, digitalisation and virtual simulation technologies at King’s Lynn?

KB: There are many opportunities to use the latest virtual simulation technologies. At Bespak, we are looking for ways to leverage these to both improve efficiency in device design and reduce waste from prototype testing. We have already completed a proofof-concept study on the use of advanced modelling and virtual simulation to map the entire design space for a pMDI valve. This allowed us to easily identify the impact of changes to design parameters and ascertain when components have deviated too far from critical-to-quality attributes and need to be rejected. A similar process can be applied to other pMDI components or to existing devices that we are considering design tweaks for, cutting down the amount of manual testing needed and offering the potential to reduce the cost and time taken on projects while improving quality and sustainability.

TD: We have also used Computational Fluid Dynamics (CFD) simulations to take a closer look at the filling of the pMDI metering valve, which is understudied despite playing a key role in ensuring dose consistency.

We explored this across both traditional and next-generation, low GWP propellants, including HFA-134a, HFA-227ea, HFA-152a, and HFO-1234ze(E). Using this technique, it is possible to predict what happens inside the metering chamber during the refill event with a high level of spatial and temporal resolution. Differences in refill behaviour for the different propellants were identified, which can be compensated for by adjusting metering valve geometry to ensure rapid refill and consistent dosing. This really serves to highlight the exciting potential of simulation Spring 2026 Volume 18 Issue 1

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Nasal and Pulmonary

Karl Bass Karl Bass is Principal Model-Based Systems Engineer at Bespak with over 10 years' experience in pharmaceutical and medical device development. A Chartered Engineer with a PhD in Mechanical Engineering.

Email: karl.bass@bespak.com

Thomas Daly technologies for streamlining the transition to low carbon pMDIs.

What do you wish more people knew about your work at King’s Lynn?

Can you tell us about any future project you have planned that you’re particularly excited about?

TM: I am really proud of the depth of knowledge and flexibility we offer at King’s Lynn. When it comes to building and testing our products, we can offer customised bespoke fixturing, low volume line production, high volume line support – all in-house. This allows us to design, build and test manufacturing equipment for low volume devices and development work if needed. It is the fact that all of those different areas intersect at King’s Lynn that gives you that one-stop shop. What this means for our customers is that they can dip in and out as needed, whether it’s just early-stage work or also scale up and manufacture that’s on the cards.

KB: Beyond models for drug and device product development, we’ve started looking into the potential for in silico clinical trials for respiratory drug delivery with some early-stage collaboration and support from UK-CEiRSI. In essence, this would involve developing models of airways and evaluating the transport of aerosols through the respiratory tract with a computer simulation.

CT scans would be used for the models initially and can be supplemented with generative AI to expand the dataset to support the scale of a clinical trial. When the aerosol reaches the lower airways, simplified models can be efficiently utilised in more distal regions of the lungs. Once the aerosol is deposited in the airways, it is then possible to model absorption and dissolution of the active pharmaceutical ingredient into the bloodstream to determine pharmaceutical effects with physiologicallybased pharmacokinetic (PBPK) models. All of that can be repeated and combined thousands of times to augment real-world clinical data.

SW: Just to add to that, with this early work assessing the potential for in silico clinical trials , we are taking a step closer to bringing both device and drug together as a combination that can be modelled from start to finish. This is the future goal of our team here at Bespak and something that I am very excited about.

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SW: We don’t rest on our laurels at King’s Lynn but are constantly evolving. Our use of the latest virtual simulation technologies is one example of that, but is not the only way in which we are working to stay at the forefront of the sector. Our Injection Moulding Academy has garnered widespread praise and awards for providing muchneeded upskilling to the UK manufacturing industry, and we are expanding the training on offer in 2026. We developed a hybrid BK357 pMDI metering valve for next-generation propellants and completed a Life Cycle Assessment on the BK357 valve to identify further ways to improve sustainability.

The skill and experience of our team make these leaps possible, and our commitment to staying at the cutting edge helps us to push the envelope even further.

Thomas Daly is a Development Engineer at Bespak, specialising in pMDI metering valve development. He holds a BEng (Hons) in Mechanical Engineering and is completing a PhD focused on modelling next-generation low-GWP propellant systems.

Email: thomas.daly@bespak.com

Tony Mallett Tony Mallett is Platform Development Group Manager at Bespak with over 23 years' experience in medical device CDMO. He leads New Product Introduction across pMDIs, DPIs and nasal devices from concept to commercialisation.

Email: tony.mallett@bespak.com

Shaun Williams Shaun Williams is Product Engineering Manager at Bespak and a Chartered Mechanical Engineer with nearly 20 years' experience. He specialises in DPI, and SMI device development, supporting design, lifecycle management, and global commercial launch.

Email: shaun.williams@bespak.com

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Spray Pattern and Plume Geometry:

Regulatory Convergence and Technological Innovation in Inhaled and Nasal Drug Products Spray Pattern (SP) and Plume Geometry (PG) testing have long been incorporated into U.S. regulatory expectations and are now explicitly addressed in the 2026 revision of the European Medicines Agency guideline on inhalation and nasal medicinal products.

Importantly, the revision explicitly incorporates SP and PG as characterisation tests (where appropriate) and notes their use to ensure consistency during development and as a baseline for comparability assessments and lifecycle changes.

This evolution reflects broader international movement toward increasingly data-driven and development-stage in vitro performance assessment of orally inhaled and nasal drug products (OINDPs).

Concurrently, advances in high-speed digital imaging and automated image analysis have transformed SP and PG from primarily static geometric descriptors into dynamic, data-rich measurements capable of capturing transient plume behaviour.

Modern platforms, including SprayVIEW® measurement system with Viota® software, enable extraction of both conventional metrics and time-resolved parameters such as plume front velocity, supporting deeper mechanistic understanding of aerosol momentum and product performance.

Together, regulatory alignment and technological innovation have elevated SP and PG testing from supportive visualisation tools to central elements of quality assessment, comparability evaluation, and lifecycle management strategies. As OINDP development increasingly emphasises data-driven and mechanistically informed approaches, advanced spray characterisation plays a critical role during product development, where it supports formulation optimisation, device selection, and demonstration of performance consistency.

OINDPs are complex drug–device combination products in which therapeutic performance depends on tightly coupled inter80 INTERNATIONAL PHARMACEUTICAL INDUSTRY

actions between formulation properties, device design, and patient use. Unlike conventional oral dosage forms, aerosolised drug delivery involves highly dynamic processes, including atomisation, plume formation, droplet evaporation, and particle transport. Consequently, regulatory authorities require a multifaceted in vitro characterisation strategy, incorporating tests such as delivered dose uniformity, aerodynamic particle size distribution (APSD), and spray characterisation to ensure consistent performance and product quality.

Among these tools, SP and PG measurements serve as critical in vitro characterisation techniques, providing direct visual and quantitative assessment of aerosol formation at the point of actuation. These tests evaluate the size, shape, and spatial distribution of emitted sprays and plumes and have historically been used as indicators of device performance consistency and formulation– device compatibility. Established for over two decades in U.S. Food and Drug Administration (FDA) guidance, SP and PG testing have supported product development, quality control, and regulatory submissions, while also offering mechanistic insight into formulation– device interactions.1,2 More recently, the European Medicines Agency (EMA) has explicitly incorporated SP and PG into the updated guidance for inhalation and nasal medicinal products.3 This reflects evolving international regulatory expectations and increasing recognition of the value of comprehensive in vitro performance assessment in supporting product quality, comparability, and bioequivalence assessments.

Industry groups such as the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) have also documented the value of SP and PG testing methodologies, reflecting broad scientific consensus on their relevance for capturing product performance characteristics in regulatory and comparability assessments.4 In parallel with regulatory developments, advances in high-speed imaging and quantitative image analysis have transformed SP and PG from primarily static or qualitative measurements into highly quantitative tools capable of quantifying aerosol behaviour.

Modern imaging platforms enable extraction of parameters such as plume front velocity and evaporation rate, providing deeper insight into aerosol momentum, droplet evolution, and transient plume dynamics.

This article reviews the regulatory evolution of SP and PG testing, highlights recent EMA guidance updates, and discusses how modern imaging technologies are expanding the scientific and regulatory utility of spray characterisation for OINDP development, regulatory submission, and lifecycle management.

Advanced Imaging Platforms for Spray Characterisation One example is the SprayVIEW system (Proveris Scientific), a high-speed imaging platform designed for quantitative assessment of SP and PG using Viota software. The platform combines high-resolution imaging with advanced analysis to capture plume development over time, extracting both traditional geometric parameters and dynamic metrics. By converting visual plume behavior

Orally Inhaled and Nasal Drug Products, Left to Right: Dry Powder Inhaler, pMDI Inhalers, Multidose Nasal Spray, Soft Mist Inhaler Spring 2026 Volume 18 Issue 1

Nasal and Pulmonary into analysable data, SprayVIEW with Viota supports reproducible measurements when appropriately validated and controlled.

This integrated system allows researchers to correlate droplet evolution with Plume Geometry and velocity, offering a structured quantitative assessment of aerosol performance. Together, the hardware and software enable robust characterisation, supporting formulation optimisation, demonstration of comparability, and regulatory submissions.

Recent EU Guidance and Regulatory Convergence In 2024–2025, the EMA issued an updated draft guidance on the pharmaceutical quality of inhalation and nasal medicinal products, explicitly incorporating SP and PG into recommended characterisation tests.3 The guideline specifies that SP and PG should be assessed, where appropriate, to evaluate the performance of the complete finished medicinal product, defined as the formulation in combination with the delivery device.

This represents a major step toward convergence with long-standing U.S. practices, which have included SP and PG in Chemistry, Manufacturing, and Controls (CMC) and bioavailability/bioequivalence (BA/BE) guidance since the early 2000s.1,2 FDA product-specific guidances have further emphasised SP and PG for certain nasal sprays and inhalation products, reinforcing their role in regulatory submissions.5 Historically, the EU draft guideline (Oct 2004) did not reference SP and PG, highlighting the evolution of European expectations. The final EMA guidance positions SP and PG as integral components of in vitro performance characterisation, alongside APSD, droplet size distribution (DSD), and delivered dose.

Top left and right: Spray Pattern are the cross-sectional views of the spray that is perpendicular to flow direction, usually measured at 2 distances (e.g. 30 mm and 60 mm) from the tip of the mouthpiece or nasal spray edge.

Bottom right and left: Plume Geometry is the cross-sectional view of the spray that is parallel to the nominal flow direction, usually measured at 1 distance (e.g. 60 mm) from the tip of the mouthpiece or nasal spray edge.

For developers targeting European markets, this encourages earlier integration of spray characterisation into formulation and device programmes, reducing late-stage performance risks and regulatory delays. Globally, regulatory authorities increasingly view SP and PG as essential elements of comprehensive OINDP characterisation, supporting product understanding, comparability, and, where appropriate, reduced reliance in vivo studies.

Recent comparative studies have demonstrated that differences in Spray Pattern and Plume Geometry between generic and reference nasal sprays correlate with distinct deposition profiles, underscoring their importance for ensuring pharmaceutical equivalence.6 Advances in Aerosol Imaging and Plume Dynamics Modern spray characterisation has advanced significantly through high-speed

digital imaging and sophisticated image analysis. Contemporary systems combine short-duration, high-intensity illumination with high-resolution cameras capturing hundreds of frames per second, enabling detailed visualisation of plume formation from initial actuation through expansion and dissipation.

Image analysis algorithms, including edge detection, intensity thresholding, and spatial measurement routines, allow automated and consistent extraction of geometric parameters with high precision and repeatability.

Conventional Plume Geometry metrics such as plume angle, width, and height describe the spatial envelope of the aerosol cloud. Highspeed imaging extends these measurements by capturing transient plume behaviour, providing mechanistic insight that static imaging cannot resolve. Plume front velocity, influenced by formulation properties, device design, and actuation mechanics, serves as

Example of spray characterisation using SprayVIEW Measurement System. Top: Plume Geometry (side view) generated from Softmist and pMDI inhalers. Bottom Left: Plume Geometry generated (side view) from a multidose nasal. Bottom Right: Spray Pattern generated from a multidose nasal spray. www.international-pharma.com

INTERNATIONAL PHARMACEUTICAL INDUSTRY 81

Nasal and Pulmonary a sensitive indicator of aerosol momentum and overall spray performance. (see Table 1 for key definitions) Analysis of evolving plume morphology and dynamic spray behaviour has been shown to correlate with changes in aerodynamic particle size distribution and related deposition-relevant metrics in metered dose inhaler aerosols, indicating that plume characteristics can offer meaningful insight into aerosol performance beyond traditional static measurements.7,8 Advanced Analytical Platforms in Spray Characterisation Modern platforms provide high-resolution, repeatable, and analysable datasets suitable for both routine quality testing and advanced research applications. Integrated data analytics automate extraction of geometric and dynamic parameters, supporting method validation, system suitability, and trend analysis. Large datasets generated through these platforms support batch release and comparability studies, bridging the gap between in vitro measurements and mechanistic understanding.

Although Spray Pattern and Plume Geometry remain in vitro measurements, their quantitative nature enables investigation of potential in vitro-in vivo relationships. High-speed imaging and plume characterisation provide metrics such as plume front velocity, spray duration, and plume morphology that can be captured in real time and linked to aerosol behaviour.

Studies have demonstrated how variations in plume characteristics are accompanied by corresponding changes in droplet dynamics and in vitro deposition patterns, supporting the concept that these metrics can inform mechanistic models of regional deposition.8,9 Aerosol visualisation across inhaler types has shown that plume velocity and spray duration vary substantially with device and flow conditions, indicating that dynamic

plume data can serve as meaningful inputs for computational fluid dynamics simulations and deposition predictions.1,8 Regulatory guidances further recognise Spray Pattern and Plume Geometry characterisation as key in vitro attributes in assessing performance and product comparability.1,10 Laboratory Test Services and Regulatory Support Specialised laboratories offer comprehensive spray characterisation services integrating SP, PG, APSD, and additional complementary tests. These services support innovator and generic development, as well as postapproval change management, providing standardised methodologies, controlled test environments, and expert data interpretation.

High-quality, traceable data capture and reporting are essential for regulatory acceptance. Advanced reporting tools allow integration of spray characterisation metrics into broader submission narratives, supporting claims of product consistency, comparability, and robustness. SP and PG data also inform product release decisions and ongoing quality monitoring. Trends can detect subtle changes in device components, formulation properties, or manufacturing processes before performance is impacted, supporting lifecycle management.11 Practical Applications and Future Directions Enhanced spray characterisation has proven valuable in supporting OINDP development and regulatory approval. SP and PG data have informed: • • • •

Differentiation of alternative actuator designs Optimisation of formulation viscosity and excipient composition Comparability assessments for generic and reformulated products Investigation of customer complaints related to spray performance

•

Mechanistic insight during root cause analysis of deviations

Beyond product development, metrics such as plume front velocity and evaporation rate provide quantitative evidence for postapproval changes. Continued integration of these dynamic parameters is expected to further enhance scientific understanding and regulatory decision-making. Advanced SP and PG metrics may increasingly guide formulation and device optimisation while supporting regulatory submissions.

Conclusions The regulatory and scientific framework for SP and PG testing has evolved substantially over the past decade. Historically emphasised within U.S. regulatory guidance, these measurements are now explicitly addressed in updated EMA guidance, reflecting increasing global harmonisation in expectations for OINDP characterisation. This convergence underscores the growing recognition of SP and PG as meaningful contributors to in vitro performance assessment.

Advances in measurement technology have expanded the scope and resolution of SP and PG evaluation. High-speed imaging, integrated data analytics, and platforms such as SprayVIEW and Viota have enabled the transition from static geometric descriptors to quantitative characterisation. Parameters including plume front velocity, evaporation behaviour, and plume evolution over time provide mechanistic insight into aerosol behaviour and performance, supporting regulatory decision-making and product evaluation.

Specialised laboratory testing services continue to play a central role, providing standardised methodologies, controlled test environments, and expert interpretation. As the industry increasingly adopts data-driven and mechanistically informed development strategies, SP and PG characterisation remains

Parameter

Definition

Units

Relevance to Product Performance

Spray Pattern Area

Total area covered by the spray at a defined distance from the nozzle

mm²

Reflects the overall spatial coverage and dose distribution potential

Spray Pattern Ovality

Ratio of the major axis to the minor axis of the spray ellipse

Dimensionless

Indicates uniformity and symmetry of the spray; high ovality may suggest directional bias

Plume Width

Lateral spread of the plume at a specific distance from the nozzle

mm

Influences deposition area and dose uniformity in the nasal cavity or lungs

Plume Angle

Angle formed by the edges of the expanding plume

Degrees

Affects the coverage pattern and can influence deposition efficiency

Plume Front Velocity

Speed of the leading edge of the aerosol plume immediately after actuation

m/s

Reflects aerosol momentum and transient behaviour; sensitive to formulation/device characteristics

Table 1. Key Spray Pattern and Plume Geometry Metrics 82 INTERNATIONAL PHARMACEUTICAL INDUSTRY

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Nasal and Pulmonary 4.

5.

6.

7.

8.

9.

10.

11.

(A) Plume Front Velocity image captures taken with the SprayVIEW system camera produce a series of data points consisting of distance and time components until the plume has left the field of view. (B) Graph plots of the distance versus time data points based on calibrated, time-synchronised plume sequence analysis.

Baxter S., Myatt B., Stein S.W., et al. Spray Pattern and Plume Geometry Testing and Methodology: An IPACRS Working Group Overview. AAPS PharmSciTech. 2022;23(5):145. doi:10.1208/ s1224902202278w. PubMed U.S. Food and Drug Administration. Product specific guidances for generic drug development. n.d. https://www.fda.gov/drugs/ guidances-drugs/product-specific-guidancesgeneric-drug-development Morita T., Yoshida H., Miyazaki T., Tomita N., Sato Y. Analysis of spray pattern and plume geometry differences between generic and brandname nasal sprays. J Drug Deliv Sci Technol.

2025;108:106949. doi:10.1016/j.jddst.2025.106949.

ScienceDirect Smyth H, Hickey AJ, Brace G, Barbour T, Gallion J, Grove J. Spray pattern analysis for metered dose inhalers I: Orifice size, particle size, and droplet motion correlations.

Drug Dev Ind Pharm. 2006;32(9):1033‑1041. doi:10.1080/03639040600637598. PMID:17012116 Zhou Y, Yang B, Hong C, et al. Correlation between dynamic spray plume and drug deposition of solution‑based pressurized metered‑dose inhalers.

J Aerosol Med Pulm Drug Deliv. 2024;37(5):232‑240. doi:10.1089/jamp.2023.0050. PMID:39007176 Wachtel H, Emerson-Stadler R, Langguth P, et al. Aerosol plumes of inhalers used in COPD: in vitro characterization of velocity and duration.

Pulm Ther. 2024.

Proveris Scientific. A novel characterization of emitted aerosol velocity profiles from metered dose and soft mist inhalers. 2021. Available from: https://www.proveris.com/wp-content/ uploads/2021/02/A-novel-characterizationof-emitted-aerosol-velocity-profiles-frommetered-dose-and-soft-mist-inhalers.pdf Rachapally A., Boddu R., Kollipara S., Ahmed T. Bioequivalence requirements for orally inhaled and nasal drug products and use of novel physiologically based biopharmaceutics modeling approaches for assessing in vivo performance. J Pharm Sci. 2025;114(2):701–718. doi:10.1016/j.xphs.2024.10.009

Maria Smith Spray Duration Measurement – an example of time-averaged plume results (left) with time-synchronised intensity profile (right, white curve) indicating the spray duration (58–304 ms).

essential for demonstrating product quality, performance, and consistency in alignment with global regulatory expectations.

REFERENCES 1.

U.S. Food and Drug Administration.

Bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action (Draft guidance). 2003. https://www.fda.gov/ files/drugs/published/Bioavailability-andBioequivalence-Studies-for-Nasal-Aerosolsand-Nasal-Sprays-for-Local-Action.pdf

www.international-pharma.com

2.

3.

U.S. Food and Drug Administration. Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing, and Controls Documentation (Guidance for Industry). 2002. https://www.fda.gov/media/70857/download European Medicines Agency. Guideline on the pharmaceutical quality of inhalation and nasal medicinal products: Revision 1 (EMEA/ CHMP/QWP/49313/2005 Rev. 1). Adopted 14 July 2025; legal effective date 01 February 2026. https://www.ema.europa.eu/en/documents/ scientific-guideline/guideline-pharmaceuticalquality-inhalation-nasal-medicinal-productsrevision-1_en.pdf

Maria Smith is Director of Applications and Business Development at Proveris Laboratories, with over 19 years of experience in orally inhaled and nasal drug product development. A recognized expert in spray characterization, she has contributed to more than fifteen combination NDA and ANDA submissions across R&D and QC. She leads Proveris with a weight of evidence mindset that balances regulatory rigor and innovation.

Web: www.proverislabs.com Email: contactus@proveris.com

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Exhibitions & Events

Chemspec Europe Sets the Agenda for Fine and Speciality Chemicals Chemspec Europe 2026 will once again bring together producers, procurement professionals and technical experts from across the fine and speciality chemicals landscape. Creating a meeting point for a range of industries such as pharmaceuticals, agrochemicals, speciality materials, coatings, personal care, electronics and energy. As regulatory demands tighten, sustainability expectations rise and supply chains remain under pressure, the two-day event offers a timely snapshot of how the sector is adapting and where it’s heading next.

As a cross-industry hub, Chemspec Europe is expected to bring together more than 400 global suppliers on the exhibition floor, covering custom synthesis, contract manufacturing, formulation, scale-up and specialist services. Companies including Albemarle, Brenntag, CABB Group, Johnson Matthey, Saltigo and Yashashvi Rasayan will be among those showcasing their capabilities, giving visitors a clear view of current approaches and expertise across the fine and speciality chemicals value chain.

Alongside the exhibition, Chemspec Europe 2026 will feature two conference streams reflecting the technical and strategic challenges facing today’s market. The Moleküle Hub will focus on innovation, process development and emerging process technologies, while the Strategy Stage will turn to the broader commercial, regulatory and geopolitical forces shaping the sector.

Innovation and Manufacturing Insight at the Moleküle Hub The Moleküle Hub places the spotlight firmly on how chemistry is manufactured and scaled.

Digitalisation and advanced manufacturing run through much of the programme, with several sessions exploring how data, automation and artificial intelligence are changing the way companies approach R&D and production.

tools are being used to speed up discovery, improve operational decision-making and enable new approaches to innovation. The session highlights how intelligent systems can shorten development cycles, increase reliability in production and reshape competitiveness across the value chain.

Manufacturing innovation is another core theme. In Pharma manufacturing: Scale-up of continuous-flow reactions, speakers from Fluitec and Lonza will examine fully continuous approaches to synthesising and manufacturing high-value APIs and drug products. By linking reaction and purification steps within controlled flow environments, these systems offer improvements in safety, product quality and scalability, while remaining compatible with GMP requirements.

The journey from lab to production is explored further in sessions focused on modular custom manufacturing. These discussions follow the path from early route ideation through to commercial-scale delivery, including the use of modern tools such as AI and 3D printing.

Rounding out the technical programme, sessions on continuous flow technologies will explore how moving beyond traditional batch processing can support faster, more reliable scale-up. Real-world industrial examples will show how improved heat transfer, mixing and reduced chemical hold-up can help companies bring products to market more quickly without compromising performance.

Strategic Insight for a Changing Global Landscape Running in parallel, the Strategy Stage takes a wider view of the forces shaping the fine and speciality chemicals sector. A keynote panel, Scaling, adapting and partnering for the future, brings together senior figures from Saltigo, High Force Research and FECC to discuss how businesses can navigate an

increasingly complex operating environment.

Topics include geopolitical uncertainty, trade pressures, regulatory change and the growing importance of collaboration in building resilience and unlocking new opportunities.

Digital transformation also features strongly from a strategic perspective.

Accelerating innovation: Reduce time-tomarket by digitising early-stage development will explore how data driven experimentation and predictive tools can help teams move from concept to commercial reality. Meanwhile, Smart products: Accelerating chemical R&D with AI and simulation focuses on the practical use of modelling and simulation to optimise formulations, processes and resource efficiency, supporting faster innovation with a lower environmental impact.

A Focused View of What Comes Next Together, the exhibition and conference programme highlight where fine and speciality chemicals are heading. With a focus on the process technologies and strategic questions which are gaining momentum right now. In a complex and fast-moving market, Chemspec Europe 2026 creates space for informed conversation across the fine and speciality chemicals community.

Chemspec Europe will take place at Koelnmesse, Germany from 6–7 May 2026. www.chemspeceurope.com/en-gb. html?utm_source=Advert&utm_medium= Referral&utm_campaign=Senglobal_-_IPI_ preview&utm_content=&utm_term=

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