problem: moisture-absorbing packets for humidity, and oxygen scavengers for air. However, Aptar CSP’s technology combines both functions into one integrated material, simplifying packaging and improving drug protection.
Regulatory compliance with global standards for stability and safety is a critical aspect of Aptar CSP’s dualactive material science technology, which is designed to help companies meet International Council for Harmonization (ICH) requirements for how stable a drug must be under various conditions.
According to Aptar CSP, there has never been a singular, standalone active material aimed at protecting against both oxidation and moisture-related degradation at this level
Lonza Design2Optimize platform
of precision across multiple platforms. The company notes that its technology can be customized for a range of product formats and development stages, from early R&D to commercial launch, including oral solid dose glucagon-like peptide-1 (GLP-1) medications — which are particularly vulnerable to both moisture and oxygen.
Dual-active material science technology
The solution is based on Aptar CSP’s 3-Phase Activ-Polymer technology, incorporating active chemistries to provide moisture control, gas scavenging (including oxygen, carbon
Aptar CSP
dioxide, ethylene, formaldehyde, nitrosamines), microbial pathogen reduction, as well as aroma reduction or emission. The dual-active material is formed into films, blisters, or inserts, which are then incorporated into the final packaging. However, this can also occur during the manufacturing process to ensure the package is protected from the beginning.
Process development, manufacturing of APIs
Over the past two decades, the complexity of small molecule active pharmaceutical ingredients (APIs) has surged. Consequently, many development pipelines now require 20 or more synthetic steps with researchers testing many routes and reaction
conditions to reach the final product — a time-consuming and resourceintensive approach.
However, working with the Fraunhofer Institute for Industrial Mathematics, Lonza has developed the Design2Optimize platform which enhances process development and manufacturing of small molecule APIs by using optimized experimental design to extract maximum insight from fewer experiments, producing faster decision-making, lower costs, and a streamlined process.
Lonza’s Design2Optimize platform combines physicochemical and statistical models with a continuous optimization loop, a hybrid proprietary approach to chemical process development — even for complex or poorly
understood reactions — that significantly reduces experimentation time and resource use accelerating the path to manufacturing.
A major innovation of Design2Optimize is that it creates a digital twin for each process to facilitate in silico scenario testing and predictive modelling, while reducing the reliance on physical trials and speeding up development timelines, according to Lonza. The platform is based on an optimized design of experiments (DoE), enabling drug developers to build predictive models much more quickly. The physicochemical models provde a better understanding of possible synthetic methods than empirical models generated with statistical DoE.
EQUIPMENT CLEANING VALIDATION YOUR
The Hopewell facility features what the company contends is the first fully connected continuous manufacturing technology — the EnzeneX 2.0 platform, offered as an alternative to traditional batch processing and designed to produce high-quality biologics with increased precision and efficiency as well as lower cost of goods.
The platform incorporates process analytical technology (PAT) to enable real-time monitoring and control for consistent quality and optimized processing, according to Enzene.
“We’ve successfully taken our first trial batch and we’ve manufactured four kilograms of material in just 200 liters,” Enzene CEO Himanshu Gadgil said at the grand opening ceremony for the biomanufacturing plant. “With a conventional process, you need at least 2,000-liter capacity to do this. We’ve done it in 200 liters.”
When Enzene eventually runs the process “full throttle” at the Hopewell site, Gadgil claims the CDMO “should be able to get around 15 to 20 kilograms from 400 liters,” which typically requires up to a 5,000-liter bioreactor capacity. The facility is expected to go into commercial manufacturing as early as 2027.
Gadgil also noted that the modular EnzeneX 2.0 platform occupies a smaller footprint than that of conventional fed-batch systems and integrates the full production process, from bioreactor to downstream purification in a seamless flow.
“In this small room we can manufacture tons of product in a year,
which otherwise you’d need a manufacturing facility as big as this whole campus to achieve,” Gadgil said.
Russ Miller, vice president of global sales and marketing at Enzene, called the Hopewell site “one of the most advanced biologics manufacturing facilities in the U.S.” Initially, the CDMO’s plant will target the antibody-drug conjugate market and later cell and gene therapies.
At the same time, Eli Lilly has sold its 25,000 square-foot production site in Branchburg, New Jersey to South Korea’s Celltrion, a manufacturer and exporter of biosimilars. The 37-acre site includes four buildings and 10 acres of vacant land for future development.
Celltrion valued the acquisition at approximately 460 billion KRW ($336 million), with total costs including operational funds expected to reach about 700 billion KRW ($503 million). The company said the deal, executed through its U.S. subsidiary, will allow it to commence operations immediately while retaining the facility’s existing workforce.
It will take 12 to 18 months to validate the site before shifting production of its products to Branchburg. In the interim, existing contract manufacturing agreements at the facility will generate revenue and support a faster recovery of investment, according to Celltrion.
Surge in leasing
Pharmaceutical and life science companies accounted for nearly 30%
In this small room we can manufacture tons of product in a year, which otherwise you’d need a manufacturing facility as big as this whole campus to achieve.
— Himanshu Gadgil, CEO, Enzene
of New Jersey leases signed in the second quarter of 2025, the highest volume of activity among different business sectors, according to JLL. In Q2 2025, life sciences companies inked three of the five largest leases.
“The fact that life sciences companies accounted for nearly 30% of all leasing activity in New Jersey last quarter speaks volumes about the sector’s resilience and long-term commitment to the region,” said Benson.
As lead for JLL’s New Jersey Life Science and Biotech practice, Benson said “this is particularly evident in landmark transactions like Haleon’s headquarters move to Berkeley Heights and Acadia Pharmaceuticals’ expansion in Princeton, each signaling strategic growth and confidence in New Jersey’s infrastructure and workforce.”
When it comes to Q2 real estate sales, JLL highlighted Sun Pharmaceuticals’ $20.2 million acquisition of a 99,740-square-foot facility in Princeton from seller ML7. In March, the NJEDA board approved $5.24 million in tax credits under the Emerge Program to support Sun’s new U.S. headquarters in Princeton. As part of the agreement, Sun will remain in New Jersey for a minimum of 11 years.
“Amid ongoing macroeconomic and funding uncertainties, many New Jersey life sciences companies are likely to maintain a cautious approach to their real estate decisions, mirroring a trend seen in other major U.S. life sciences cluster markets,” JLL concluded in its report.
However, Benson commented that while the state may see more conservative leasing in the second half of 2025 due to capital market pressures, the first half of the year “underscores that New Jersey remains a premier destination for biotech and pharmaceutical growth.”
Paolo Braiuca Lead Life Sciences Practice, Seeq
Enhance maintenance and reliability with advanced analytics
Advanced analytics platforms are empowering business decision makers to evolve operations strategies, save costs, and optimize productivity.
The pharmaceutical industry is renowned for its innovative drive and cutting-edge research in the continual pursuit of excellence. However, manufacturing in the space has remained largely conservative and risk averse. As a result, this sector is lagging behind several others in adopting digital technologies. Hesitance to change can be attributed to regulatory constraints, the inherent complexity of adjusting operations, and the sensitive nature of production data.
Despite these hurdles, the industry is gradually embracing digital transformation in manufacturing, increasingly warming up to cloud solutions and data-driven operations. The past few years have been pivotal in accelerating this shift, propelled by lessons learned during the COVID-19 pandemic and the challenges posed by rapidly changing market dynamics, drug shortages, and the imperative of ensuring patient safety.
While many organizations are still restructuring production lines in the aftermath of the pandemic, it is common to see pharmaceutical manufacturing facilities operating at full capacity once again. In this context, unplanned equipment downtime can create losses worth millions of dollars, in addition to potential reputational damage and regulatory compliance red flags.
Industry is taking note: according to recent market research by Axendia, 63% of surveyed pharmaceutical companies are already implementing or considering predictive maintenance strategies in their manufacturing operations.
Opportunities to improve OEE
Pharmaceutical manufacturing is notoriously inefficient, with an average overall equipment effectiveness (OEE) of just 35%. This figure is significantly
digitally connected assets from multiple vendors.
To effectively scale and properly analyze data from every stage of manufacturing, organizations must develop data storage, consolidation, and contextualization standardization. Advanced analytics platforms significantly ease this and many other digital transformation functions, providing flexibility and empowering subject matter experts (SMEs) to make informed and timely decisions. These software platforms aggregate, cleanse, and integrate data from disparate systems, presenting it in intuitive and actionable formats for personnel to understand the full process picture and respond appropriately.
Equipment health, reliability
As William Golding wisely observed in the 1954 classic Lord of the Flies, “the best ideas are the simplest.” When it comes to equipment health, reliability is very frequently tied inversely to usage. For instance, a valve that has cycled 10,000 times is much more likely to require maintenance than one that has cycled a mere 100 times.
At Genentech, a leading biotech developer, facility engineers recognized this basic principle when viewing maintenance schedules against usage data for various assets. The team leveraged Seeq, an advanced analytics platform, to quickly aggregate data of different nature and from different
sources to correlate usage and maintenance patterns via a well-tested conditional analysis approach.
The revelations produced groundbreaking insight. The company was previously overspending on maintenance for underutilized equipment, leading to unnecessary production stoppages. Simultaneously, heavily used assets were being maintained on the same interval, increasing the risk of failure compared to the lesser-used assets.
By leveraging the advanced analytic platform’s capabilities to scale analytics and automate reporting, Genentech shifted its maintenance strategy, leading to a radical cultural shift in the engineering team. The move toward usage-based maintenance yielded significant savings, freed up production scheduling, and ultimately boosted equipment availability and overall production capacity.
Iterating and scaling
While simple concepts can drive profound operational changes, more complex solutions are sometimes necessary. For example, medicine maker, Lilly, developed an algorithm within its advanced analytics platform to detect anomalies and provide prescriptive maintenance recommendations. At the core of this sophisticated solution combining early detection of reliability issues, smart alarm management, and machine learning, company engineers
Figure 2: Calculation of leading indicator and its trending analysis indicating likelihood of equipment failure increasing. COURTESY OF SEEQ
began by identify several leading indicators. These indicators are based on signals from probes and other sensors to detect equipment reliability issues early on.
In the final stage of Lilly’s purified water production process, just before introduction to the process supply line, water temperature is monitored and altered as needed by a heat exchanger and control valve. By calculating the daily cumulative open time of this valve and analyzing its historical trend (Figure 2), engineers set the baseline for “normal behavior.” The team used this baseline as a reference to identify and quantify deviations as early signs of heat exchanger issues.
When the valve spends more time than normal in the open position, the engineers know the heat exchanger is becoming less efficient. This proactive signal prompts timely maintenance, ensuring an uninterrupted supply of purified water to the production line to prevent potential disruptions.
Power of scalable analytics
Modern advanced analytics platforms provide a unified workspace for collaborating, tracing activities, and iteratively refining the algorithms. By embracing these advanced techniques, pharmaceutical companies can optimize equipment health, reduce downtime, and respond more flexibly to market demand, delivering high-quality products in reliable timeframes.
QC leaders are turning to a unified, cloud-based LIMS to manage lab processes.
Today’s advancements in pharma and biotech would have been unthinkable just a few decades ago. Brand-new modalities and other progress have made an impact on the world, earning recognition for the R&D teams behind these breakthroughs in drug discovery. However, behind the scenes are the teams ensuring quality, safety, and efficacy of both groundbreaking treatments and everyday medicines: quality control (QC) laboratories. Despite their critical role in delivering safe and effective treatments to patients, many QC labs have trailed in modernizing their infrastructure in comparison to R&D labs. The reality is that many are ensuring quality with outdated software, disconnected data, and
paper-based workflows. This environment is prone to delays and bottlenecks and increases the risk of human error.
The consequences of inefficiencies facing QC laboratories extend far beyond the bench. Regulatory audits have become increasingly complex and costly, and mistakes in the lab impact both time to market for new therapies, and critical patient supply for commercial drugs.
There is an opportunity to modernize QC and move beyond complex patchwork solutions that contribute to errors, lack real-time visibility, and require high maintenance costs. But are QC labs ready for modernization and different ways of working? They must be if companies want to move toward a digital, agile, and scalable QC center of excellence.
Entering a new era for advanced quality control labs
Introduced in the 1980s to replace paper ledgers, laboratory information management systems (LIMS) aimed to enhance compliance through digital data capture and audit trails. These systems, built on the tech of the time; client-server architectures, relied on on-premises servers, databases, and software installations, requiring extensive IT support and validation efforts.
While these systems helped pave a path toward advancements in QC processes, the heavy customization to align with industry specific laboratory processes, ongoing master data management, and periodic major upgrades have consumed IT resources and driven up costs. These demands often exhaust lab and IT budgets, preventing QC labs seeing beyond their LIMS instance.
It is unfortunate that after more than 30 years since the introduction of LIMS, paper-based workflows remain prevalent in QC laboratories for tasks such as sample tracking, instrument logbooks, and test execution documentation. Manual data transcription between instruments, paper records, applications, spreadsheets, or reports increases risk of errors at every step. The outcome is slower testing cycles and increasing regulatory vulnerabilities.
Maintaining the traditional approach of using paper to execute QC lab processes is contributing to challenges in talent retention and operational productivity. Efforts to reduce paper usage through additional digital tools, such as electronic lab notebooks (ELNs) and laboratory execution systems (LES) typically function in isolation and are popular initiatives in QC. Yet, they create complexity for the lab analyst and reviewer by adding another application for interaction, necessitate complex integrations to share data with core LIMS applications, and compound on the challenges of
A cloud-based LIMS provides companies with regular updates, delivered incrementally and validated to meet regulatory requirements
managing master data–which must be kept perfectly in sync, a difficult activity in an environment constantly executing change control.
The approach isn’t an ideal long-term solution since maintaining master data across disparate systems can disrupt integration and undermine data integrity. These digital tools also require ongoing validation and maintenance, a costly expense as companies try to drive innovation in QC.
Companies are beginning to challenge the status quo for QC, adapting a visionary approach to laboratory operations where lab management, execution, and review can be completed in a single “full-stack” application offering industry standard processes. This consolidates the QC technology ecosystem and eliminates the need for paper processes for a more efficient and effective manufacturing lab.
Advancing QC operations with a cloud-based LIMS
Moving beyond the traditional legacy solutions and the heavily paper-based environments of today, QC leaders are turning to a unified, cloud-based LIMS to manage lab processes. These teams are adding solutions on a cohesive SaaS platform that can bring together quality assurance (QA) and QC while eliminating the need for on-premises servers and continuous validation.
The reduction of physical servers alone offers significant cost savings and provides scalability to deploy the new systems across multiple sites. When evaluating a LIMS, look for a solution that enables the execution of core QC functions, including sample management and chain of custody, inventory and equipment management, test method execution, and reporting. The solution ideally would span across industry standard workflows for release testing, stability, and environmental monitoring. Being able to complete these tasks within a single application can streamline lab operations, improve lab productivity, and strengthen compliance.
Here are additional considerations for an advanced cloudbased LIMS:
• Embedded stepwise test method execution and standardized workflows based on industry best practices can
eliminate the need for a separate lab execution system (LES)
• Instant access to current, effective procedural documentation in LIMS prevents use of outdated instruction to improve compliance
• Features such as advanced automated data capture, keyword search capabilities, and instructional multimedia can enhance accuracy and efficiency during testing.
A cloud-based LIMS provides companies with regular updates, delivered incrementally and validated to meet regulatory requirements (Figure 1). This keeps the platform aligned with industry standards without requiring extensive IT intervention. The updates, informed by user feedback, also introduce enhancements that minimize operational disruptions. Not having on-premises servers reduces infrastructure costs and validation burden and allows for rapid deployment.
By consolidating data and processes into a single cloud LIMS, companies can reduce manual transcription and digitally capture diverse data types, including numerical results, text entries, and instrument data, and validated calculations. This improves the review process and enhances data integrity, taking companies one step closer to a connected QC lab.
Making a case for QA-QC connectivity
Connecting QA, QC, and training on a single platform is an innovative way to drive greater operational efficiency while maintaining rigorous standards, including GMP and FDA regulations. With access to real-time data across the functions, teams can trace batch data and results and execute cross functional, end-to-end workflows to minimize compliance risks. Companies with a connected QA and QC landscape can gain clear visibility into laboratory processes and optimize resources for a more productive QC operation.
For example, with connected QA and QC, lab leaders can verify analyst qualifications against integrated training records before test execution, preventing unauthorized personnel from conducting analyses and ensuring adherence to standard operating procedures. When deviations, such as test failures or nonconformances occur, the system can enable immediate investigation initiation within the QC environment and seamlessly link to QA for efficient collaboration for resolution and documentation.
Another way having connected QA and QC helps lab teams is by providing real-time access to QC test results and certificates of analysis. The data empowers QA teams to expedite and instill greater confidence in batch release decisions while tracking the impact of QA-driven changes, such as revised specifications or change controls stemming from QC activities like ongoing tests, samples, and stability studies.
Automated workflows can also guide staff through multistep test processes, track equipment and sample usage, and capture results digitally, eliminating redundant manual data entry and enhancing accuracy. The approach simplifies IT management, lowers operational costs, and provides a more collaborative, compliant laboratory ecosystem.
Building a connected lab of the future
While systems outside QC have become more innovative and robust, QC teams deserve the same technological advancements to address operational complexity brought on by the development of advanced medicines and therapies. Change is within reach as cloud-based LIMS solutions built on flexible and compliant platforms are available today. By moving from legacy systems and processes to the cloud, QC labs can streamline daily operations and build a strategic, responsive quality control ecosystem.
Supported by a leading LIMS, organizations can realign QC’s scope with its original intention of complete compliance, regardless of complexity, and efficient product release. QC teams will then be able to deliver safe, high-quality therapies to market faster, and with more confidence.
Figure 1: The Benefits of a True SaaS LIMS Solution. Source: Veeva
Russell Prestipino Global Business Development Manager, Colorcon
Overcoming technical challenges
The critical role of pharmaceutical excipients in solid oral dose formulations
What are pharmaceutical excipients?
Excipients are inert substances that combine with the API and serve multiple purposes, including (but not limited to):
• Enhancing flow and compressibility during manufacture
Due to their convenience, product stability, and patient acceptability, tablets and capsules remain the most widely used pharmaceutical dosage form. While active pharmaceutical ingredients (APIs) are the therapeutic drivers, excipients often go unnoticed, but they play a pivotal role in ensuring the manufacturability, stability, and performance of drug formulations.
• Improving stability of the finished dosage form
• Modulating drug release profiles
• Aiding in taste masking and patient acceptability
• Ensuring uniformity and bioavailability
Common categories include binders, fillers (diluents), disintegrants, lubricants, glidants, and coatings. Each excipient must be carefully selected based on its compatibility with the API and its performance in the intended dosage form.
For pharmaceutical formulators and manufacturers, understanding the functional contributions of excipients, and navigating the technical challenges they present is essential for successful product development.
Improving bioavailability
In the development of solid oral dosage forms, enhancing the bioavailability of APIs is critical, especially for compounds with poor solubility or permeability. Excipients play a vital role in overcoming these challenges. Their selection and application can significantly influence the absorption and therapeutic effectiveness of a drug.
One of the primary ways excipients contribute to improved bioavailability is by enhancing the solubility and dissolution rate of poorly water-soluble APIs (like phenytoin and nifedipine).
Many modern drug candidates fall into Biopharmaceutics Classification System (BCS) Class II or IV, where solubility is a limiting factor. Cellulosic polymers like hydroxypropyl methylcellulose (HPMC) are used in solid dispersions to maintain APIs in an amorphous, more soluble state.
Beyond solubility, excipients can also enhance the permeability of APIs
across the gastrointestinal (GI) membrane. Certain permeation enhancers, such as bile salts or fatty acids, temporarily loosen tight junctions or alter membrane fluidity, facilitating better drug absorption. Lipid-based excipients, including medium-chain triglycerides, are commonly used in self-emulsifying drug delivery systems, which improve lymphatic transport and bypass first-pass metabolism.
Controlling the release profile of a drug is another critical function of excipients that directly impacts bioavailability. Disintegrants like starch, starch derivatives and croscarmellose sodium promote rapid tablet breakup, increasing the surface area available for dissolution. On the other hand, matrix-forming agents such as HPMC or ethylcellulose enable sustained or controlled release, maintaining therapeutic drug levels over extended periods and improving overall absorption.
mucoadhesive agents like Carbopol prolong the residence time of the dosage form at the absorption site, enhancing drug uptake.
Key technical challenges during formulation
Excipients also serve a protective role, shielding APIs from degradation in the harsh environment of the GI tract. Enteric coatings, such as those made from methacrylic acid and ethyl acrylate copolymer, prevent drug release in the stomach and ensure drug delivery to the intestine, where absorption is more favorable. Stabilizers like starch are used to prevent degradation, preserving the integrity and efficacy of the API by acting as a moisture scavenger.
Targeted delivery is another area where excipients make a significant impact. pH-sensitive polymers can release the drug in response to specific GI tract conditions, while
Despite their widespread use, solid oral dosage forms (SODFs) present several formulation and manufacturing challenges. These include:
API-excipient compatibility
Chemical and physical incompatibilities between APIs and excipients can lead to degradation, reduced efficacy, or altered release profiles. For example, lactose may react with primary amines in APIs, leading to discoloration and potency loss.
Conducting pre-formulation studies, including differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and isothermal stress testing, helps identify potential incompatibilities early on.
enhance the flow properties and compressibility of APIs with poor flow and compressibility characteristics. Alternatively, implementing a wet granulation process with cellulosic binders like HPMC can facilitate the agglomeration of fine particles, thereby markedly improving the blend’s flow and compressibility.
Poor flow and compressibility
Numerous APIs with finer particle grades present challenges due to their poor flow and compressibility, complicating their processing in high-speed tablet presses. This issue becomes even more pronounced when the drug dosage is very high.
The utilization of directly compressible grades of diluents or fillers, such as microcrystalline cellulose (approximately 90 μm particle size) or partially pregelatinized starch (approximately 85 to 90 μm particle size), along with flow aids, can significantly
Content uniformity
Ensuring uniform distribution of lowdose APIs is extremely important and challenging, especially when the API is present in microgram quantities.
Employing high-shear granulation or using carrier-based systems (e.g., adsorbing the API onto a larger excipient particle) can improve uniformity. Uniformity of the drug can be ensured by realtime monitoring using near-infrared (NIR) spectroscopy during the process.
Moisture sensitivity
Controlling the release profile of a drug is another critical function of excipients that directly impacts bioavailability.
Moisture is one of the major challenges for pharmaceutical drug products. It can lead to multiple complications such as hydrolytic degradation of the drug molecules resulting in impurity generation or microbial contamination. Ingress of moisture may also change polymorphic form of the drug and thereby its bioavailability. The majority of drug molecules are hygroscopic in nature; and tend to absorb moisture from the atmosphere and negatively impact stability of the drug molecule.
The use of moisture scavenging excipients such as pregelatinized maize starch in the core or use of moisture-barrier film coatings as a protective coat, either alone or in combination with the right configuration of functional packaging, can mitigate this risk.
Scale-up and manufacturing robustness
Scaling up pharmaceutical products presents numerous challenges related toregulatory compliance, cost, quality,
and flexibility. These challenges arise from the need to transition from smallscale lab processes to large-scale commercial manufacturing while maintaining product quality, cost-effectiveness, and adhering to strict regulatory guidelines. Formulations that work well at lab scale may behave significantly different during scale-up mainly due to changes in mass and shear.
Scientific understanding using Quality by Design (QbD) principles during product development is extremely important. Consideration of critical material attributes (CMA’s) of formulation components and critical process parameters (CPP’s) in Design of Experiments (DoE) to study its impact on product quality can ensure robustness across scales.
Always finish with a film coating
The aesthetic appeal of medication can significantly influence patient adherence to prescribed regimens. Large uncoated tablets can be difficult to swallow and hard to identify, leading to a decrease in patient compliance. Applying a thin aesthetic coating can aid identification for pharmacists, patients, and healthcare providers. Innovations in film coatings have significantly enhanced the swallowing experience for the end user, thereby improving patient compliance.
In addition to just an aesthetic appeal, selection of the right film coating components with scientific rationale can also help improve formulation stability. Application of film coating with relatively lower moisture vapor transmission, such as polyvinyl alcohol based polymeric films, helps improve stability of a moisture sensitive core formulation.
Regulatory considerations
In addition to their functional properties, excipients must also meet
stringent regulatory standards for safety, quality, and functionality. While many are listed in pharmacopeias (e.g., USP-NF, Ph. Eur.), novel excipients require comprehensive toxicological evaluation.
Launched in 2021, the FDA’s Novel Excipient Review Pilot Program aims to encourage innovation by allowing pre-market review of new excipients independent of a drug application. This initiative is expected to accelerate the adoption of advanced excipient technologies.
Innovations in excipient technology – the future
We’ve already witnessed excipients being engineered to perform multiple functions simultaneously. Coprocessed excipients that combine two or more components at the sub-particle level achieve synergistic effects in flowability, compressibility, or disintegration. These materials reduce formulation complexity and are particularly valuable in direct compression tablet manufacturing.
The integration of nanotechnology has and will continue to enhance solubility and bioavailability of poorly water-soluble drugs. Lipid-based carriers (e.g., solid lipid nanoparticles, nanoemulsions) and polymeric nanoparticles are increasingly used to encapsulate and protect APIs, facilitating improved absorption and stability.
The push for sustainability is fostering interest in natural and biodegradable excipients. Polysaccharides like chitosan, alginate, and starch derivatives are being modified to meet pharmaceutical standards while maintaining a low toxicity profile. Such excipients are particularly relevant for biologics and personalized medicines.
With the introduction of more complex drug molecules in the
pharmaceutical pipeline, the role of excipients will continue to evolve. Advances in computational modeling, artificial intelligence, and high-throughput screening are expected to accelerate excipient discovery and optimization.
Best practices for formulators and manufacturers
1. Define the target product profile early, including desired release kinetics, shelf life, and manufacturability.
2. Utilize resources like the Handbook of Pharmaceutical Excipients or the FDA’s Inactive Ingredient Database to guide selection.
3. Excipient manufacturers often provide technical support, including data on functionality, stability, and regulatory status.
4. Process Analytical Technology (PAT) tools like NIR and Raman spectroscopy enable real-time monitoring and control of critical quality attributes.
5. Keep abreast of regulatory updates, new excipient launches, and emerging technologies through industry forums and publications.
Conclusion
Pharmaceutical excipients are more than inert fillers — they are critical enablers of drug product performance and manufacturability. For formulators and manufacturers, a deep understanding of excipient functionality, compatibility, and regulatory status is essential to overcome technical challenges and deliver high-quality solid oral dosage forms. As the industry evolves toward more complex molecules and personalized therapies, excipient innovation will continue to play a critical role in shaping the future of oral drug delivery.
Bob Lenich Director of Global Life Sciences, Emerson
Autonomy isn’t automatic
Building toward the future of life sciences continuous manufacturing
Today’s life sciences manufacturers are facing a wider array of challenges than ever before. Competing in this new world means doing everything possible to make manufacturing more efficient, including continuous manufacturing and associated automation. With this approach, operations teams can align strategies, equipment, and personnel across a wide array of different modalities to ensure the full value chain is coordinated and running at peak efficiency.
As the need for manufacturing efficiencies continues to increase and the demand for new treatment soars, continuous manufacturing has begun to evolve, but many organizations are looking beyond traditional continuous manufacturing to pursue autonomous manufacturing. New control and data technologies, robotics, and system integration solutions have come together to move autonomous operation out of the realm of science fiction into an achievable result.
The path from continuous to autonomous manufacturing
Automation of life sciences
manufacturing using a continuous manufacturing strategy is not new. For decades, plants have been using digital technology to automate as much as possible, helping ensure that assets and processes are aligned
across the full production line for a given modality. Teams have long known that what happens with one production unit impacts others, and that errors and delays in any step can have cascading effects that ripple across production, creating bottlenecks, unexpected deviations or inventory hold-ups.
Technologies like the distributed control system (DCS), manufacturing execution system (MES), and laboratory information management systems (LIMS) — along with real-time scheduling (RTS) software — have all been an essential part of building the continuous manufacturing platform. However, for many organizations, those systems have been fragmented, creating data silos and continuing to force reliance on significant manual intervention to keep the process going — particularly when it comes to analytical methods and process verification.
Figure 1: Emerging technologies will need careful orchestration to support the shift from continuous to autonomous manufacturing.
To address manual activities, companies are discovering and testing new kinds of automation — such as robotic arms, automated guided vehicles (AGVs), etc. — to make those process elements faster, more repeatable, more reliable, and less prone to error.
While the tools exist to make these changes happen, these new technologies alone cannot support autonomy. Such a solution also requires precise orchestration, seamless data integration and mobility, and dynamic process simulation to ensure the integrated solution maintains the safety, quality, and efficiency necessary to continue delivering treatments on schedule.
The rise of artificial intelligence (AI) and machine learning (ML) technologies are making the processes of testing and verification of all these connected technologies simpler and easier to perform. This helps teams more easily ensure they are getting the results they want when operating continuously (Figure 1).
The path to autonomous manufacturing relies on these four key elements: orchestration, integrated data, robotics, and simulation.
Precise orchestration
Operations teams need a way to prove not only that they have a successful recipe, but also that its execution was flawless. Electronic batch records should be able to easily demonstrate what the process was engineered to produce and how every step of that process is followed in production, while providing evidence that those steps were followed and the results were as expected.
Accomplishing this goal starts with a process knowledge management (PKM) solution to help teams clearly specify what is needed across all the elements of an autonomous process, from materials and equipment needs
to the key operating models that will be used to ensure robotics, advanced control, and scheduling applications align. As a recipe increases in complexity across multiple technologies, paper specifications are no longer a viable solution for teams that want to develop continuous manufacturing strategies, much less autonomous ones.
For years, the DCS and MES have been the critical orchestration layer for continuous manufacturing. However, as teams uplevel their capabilities to drive toward autonomous operation, they must contend with additional systems, such as inline process analytical technology (PAT), integrated at-line LIMS, and real-time exception reviews to manage quality control in real-time. RTS also plays a key part in determining any impact of material or equipment constraints on line and facility throughput.
Organizations most successfully orchestrating the automation layer are turning to a seamlessly integrated
platform for PKM, DCS, MES, PAT, RTS, LIMS, and quality review management software. Integrated solutions on a platform eliminate the complexity of custom-engineered connectivity among isolated systems, freeing data and helping teams build the orchestration layer as a seamless whole for greater visibility and more intuitive operation.
However, simply ensuring the equipment is running properly is not enough. As teams embrace more autonomy in their continuous operations, they also need confidence that equipment and systems are working properly. To meet this need, plants add intelligent sensing devices to monitor health and manage calibration of assets, helping ensure they are all working per design. Seamlessly integrating this health and reliability management capability into the operations platform can work in tandem with the automation system to help plant personnel maintain continuous visibility of system health, while
Figure 2: Digitalization helps promote continuous visibility of process and system health.
providing automated documentation of asset health and calibration for an easier regulatory review process (Figure 2).
Seamless data
Ultimately, a core technology that will unlock autonomous manufacturing is a unified industrial data fabric that allows information to flow across all the individual elements of production — equipment, material management, orchestration, scheduling, quality management, AI tools, and more. Many plants have taken the first steps in this direction by selecting software applications that can be seamlessly integrated by design.
An industrial data fabric connects plant operation applications together to provide aggregated, contextualized data across all the elements needed to run an autonomous plant. Teams leveraging a data fabric can easily connect process data, equipment data, analytical methods data, and reliability data into recipe execution and order scheduling applications seamlessly,
and with associated context detailing what the data represents.
Making all this contextualized data easily available allows the orchestration layer to perform as designed. Advanced controls can optimize unit operations, upstream and downstream equipment can adjust operations based on what’s happening in real-time, quality targets can be met in real-time, and yield and throughput can be projected and delivered.
Integrated robotics
Once the data architecture and key technologies for continuous manufacturing are in place, teams can begin to leverage those technologies to go further, pushing them toward more autonomous operations with robotics. Material movements and additions have long required operators to move and add ingredients. AGVs have been proven in warehouse management solutions and have moved from operating inside the warehouse to also load/unload materials on the production floor. Robotic arms complete the task by adding the dispensed
materials in the proper sequence as part of the overall orchestration. Other repetitive manual tasks, like taking and processing samples, can also be done with robotic arms to improve accuracy, efficiency, and safety.
While the development of humaniform robots is very uneven and they have not yet been proven to work in life sciences industrial settings, they are getting more and more exposure and presence in other manufacturing areas, like automotive and logistics. As examples of use cases expand, life science organizations interested in optimizing efficiency will start proving them out in their own operations (Figure 3).
Comprehensive simulation
Another critical component to unlocking autonomous operation is simulation. Modeling allows an organization to perform software testing to prove that it will work.
Instead of performing live production runs at a cost of hundreds of thousands of dollars and taking critical production equipment out of production as part of testing, in silico testing allows the team to perform hundreds of runs in a medium and/or high-fidelity model without wasting supplies or equipment on each run. The model will tell the team whether the process runs to specification, and the team can follow up with three or four runs using actual materials to prove it out with certainty.
Preparing for the future
Advancements in technology — particularly inline analytical testing and robotics — have made it possible for operations teams to prove that the critical steps necessary to dramatically increase automation and reduce variability and human error can be automated.
Figure 3: As the success of robotics is proven out in other industries, it is likely to be adopted in life sciences manufacturing to further increase speed and reduce human error.
Maria Elena Gasperini Dir. of Sustainability Global Life Sciences, Jacobs
Plotting a path to net zero in life sciences
As it evolves at a rapid pace, the biopharma industry faces a critical challenge: the need to balance innovation, production at scale and speed to market with a responsibility to minimize environmental impacts. The journey to net-zero is most pressing in manufacturing and operations, which have the largest environmental footprints.
In this area, biopharma companies face a two-fold challenge: they are under pressure to decarbonize existing assets and to construct new, net-zero certified facilities. Some biopharma companies have chosen to seek the LEED (Leadership in Energy and Environmental Design) certification for new facilities. However, there is a challenge inherent in this approach: while LEED is a good starting point, it was developed for standard building. It is not designed to tackle the specific environmental challenges related to a manufacturing facility’s process, HVAC and utilities requirements.
The disconnect
As the Life Sciences industry moves to net-zero, there is an additional layer of complexity: while the leading industry players have evolved sustainable visions that have a focus on cutting carbon emissions (Scope 1,2 and 3), reducing the usage of water and minimizing waste to landfill and set corporate sustainability targets, this focus is often not reflected in capital expenditure investments.
Several factors contribute to this disconnect, including the time needed to understand priorities, secure appropriate funding and educate and train project teams. The good news is that regulatory change has created viable solutions to build net-zero manufacturing facilities.
By identifying and focusing on areas of highest risk, companies can allocate resources more efficiently and improve environmental outcomes. This approach may involve prioritizing energy-intensive processes for improvements in efficiency or targeting high-waste areas for reduction initiatives. For example, air flow rates can be reduced when people are not in the room, which can significantly reduce energy consumption without compromising product quality or safety.
Cost considerations are the primary determinant for investments in the sector — and they can significantly hinder progress in reducing emissions. Without a mindset shift, the industry risks falling short of global sustainability goals and contributing to the climate crisis.
Core business strategy
The industry must look beyond general certifications like LEED and prioritize long-term sustainability goals over shortterm cost savings. To bridge this gap, companies should integrate sustainability objectives into their core business strategy and develop
comprehensive net-zero roadmaps with clear milestones.
Allocating dedicated resources for sustainability initiatives is essential, as is implementing robust training programs to ensure that project teams understand and incorporate sustainability requirements into capital expenditure plans. Establishing a supporting governance structure and key performance indicators to measure progress towards reaching these goals can also help to track and drive improvements. This approach will ensure that sustainability goals are not just aspirational and are embedded into business objectives.
Industry should invest in innovative technologies that reduce energy consumption and water usage installing on site renewables and battery storage; considering natural refrigerants, carbon capture technologies and nature-based solutions and should optimize the temperature of the black and clean utilities.
Taking the lead
In the fight against climate change, biopharma companies must lead by example. By embracing sustainable solutions and fully integrating corporate targets into all aspects of their operations, companies can reduce negative environmental impact and improve long-term resilience and competitiveness. It is crucial for industry leaders to recognize that sustainability is not just an ethical imperative but a core business objective.
Deepa Pandey Principal Consultant, Precedence Research
Revolutionizing healthcare: The rise of biologics drug packaging
Biologics are exceptionally sensitive. They can break down with the slightest exposure to light, temperature changes, oxygen, or contaminants. That’s why packaging isn’t just about containment — it’s about protection, precision, and performance.
Think of glass vials, pre-filled syringes, and cyclic olefin polymer (COP) cartridges these aren’t just containers; they’re guardians of molecular integrity. Whether it’s Type I borosilicate glass or next-gen polymers, materials must be chemically inert to ensure drugs remain stable and potent.
What’s more, many biologics need refrigeration at 2–8°C, or even deep freezing. Packaging solutions now include insulated shippers, temperature indicators, and smart cold-chain logistics. It’s packaging that thinks and reacts.
Primary, secondary & tertiary packaging
Biologics packaging works in sophisticated layers:
• Primary packaging: This touches the drug directly like vials, ampoules, or syringes.
• Secondary packaging: Labels, cartons, and containers that provide additional protection and regulatory information.
• Tertiary packaging: The final defense, built for safe stacking and shipping across the globe.
Each layer plays a vital role in ensuring the drug reaches the patient sterile, stable, and intact.
Regulations shape the market
With stakes this high, packaging is tightly regulated. Global standards from the U.S. FDA, European Medicines Agency (EMA), and USP require compliance with Good Manufacturing Practices (cGMP). These rules aren’t just bureaucracy they’re lifelines, ensuring that no contamination, no temperature breach, and no tampering compromises patient safety.
Smart, sustainable & self-sufficient
The biologics drug packaging market is undergoing a renaissance, driven by innovation and necessity. Here’s what’s trending:
1. Smart packaging takes the lead Imagine packaging that not only stores but monitors. Today’s advanced designs include:
• Sensors for temperature and humidity
• Time-temperature indicators
• Anti-counterfeit solutions using QR codes and NFC tags
It’s packaging with intelligence built-in a game-changer for cold-chain logistics and global supply safety.
2. Sustainability in focus
From cutting down plastic to using eco-friendly materials, the industry is stepping up to meet climate-conscious standards. Recyclable components, minimalistic designs, and energy-efficient shippers are becoming the norm.
3. Rise of pre-filled syringes
No more vials and manual drawing. Pre-filled syringes are revolutionizing self-administration. They’re safer, faster, and reduce dosage errors perfect for managing chronic conditions like arthritis and diabetes.
4. AI in the packaging line
AI is quietly powering a transformation. From defect detection in glass to predictive maintenance of machines, AI is improving speed, quality, and safety while slashing downtime and costs.
Who’s leading and where?
Glass vials remain the industry gold standard, thanks to their unmatched barrier properties. However, COPbased plastics are catching up fast, offering durability and lightweight benefits without compromising safety.
North America tops the charts
Home to giants like Pfizer, Amgen, and Genentech, the U.S. leads the world in biologics packaging. With strong regulatory support and cutting-edge cold chain infrastructure, North America is setting global standards. The U.S. FDA’s 60-plus approved biosimilars as of 2024 further fuel packaging demand.
What’s next?
The future of biologics drug packaging is dynamic, digital, and data-driven. As science unlocks more lifesaving biologics, the packaging industry will continue to evolve not just keeping pace with innovation but enabling it.
Greg Slabodkin Editor-in-Chief
North Carolina’s biomanufacturing building boom is also a challenge
Home to 840 life sciences companies employing 75,000 people, North Carolina has emerged as a major biomanufacturing hub, thanks in part to long-term strategic investments that have funded training and education infrastructure to foster continued growth.
In 2024 and 2025, North Carolina saw more than $13.5 billion worth of announced life sciences investments. So far, 2024’s $10.8 billion in public announcements was the biggest year of capital expenditure in the history of the Tar Heel State, driven predominantly by manufacturing, according to the North Carolina Biotechnology Center (NCBiotech).
Yet, that level of success has also brought challenges. Companies are competing to secure a construction workforce including electricians in the Tar Heel State, where biotechnology ranks as the fastest growing sector.
Lars Petersen, CEO of contract development and manufacturing organization Fujifilm Biotechnologies, told Pharma Manufacturing at September’s grand opening of the company’s $3.2 billion biomanufacturing site in Holly Springs, North Carolina, that the state’s biomanufacturing building boom preceded the potential threat of U.S. tariffs.
“The market is very hot, and it’s gotten even hotter because of the tariff discussion,” Petersen said.
Contract development and manufacturing organizations (CDMOs) recently told analysts at Leerink
Partners that two areas of the U.S. with biomanufacturing building booms — North Carolina and Indianapolis — which were cited repeatedly as “saturated” with construction. The CDMOs warned the analysts that this is “driving talent scarcity in those clusters and longer lead times for commissioning because everyone is hiring at once.”
Jacobs, a technical professional services firm based in Dallas, Texas, provided engineering procurement construction management services for Fujifilm’s Holly Springs campus. At the grand opening, Jacobs CEO Bob Pragada said that it “took a village” to build the Holly Springs site. At the same time, he acknowledged there were “plenty” of challenges — “sometimes in waves” — but without elaborating on them.
However, Petersen told Pharma Manufacturing that in North Carolina there’s a shortage of about 10,000 electricians “so there’s a lot of fight” for that limited resource for companies building in the state. “There’s some trades that are very difficult and we need to work hard [to fill them],” he said.
Electrician shortage
Lindsay Gerding, vice president and general manager of life sciences North America at Jacobs, told Pharma Manufacturing that with a building boom also occurring in semiconductors and data centers, electricians have been “exceptionally challenging” to find in North Carolina.
“We’re trying to be innovative with how we design things so we can do as much off-site with fabrication in regions where the workforce isn’t as stretched, and do what we have to do here locally,” Gerding said. “We do have to come up with some creative strategies when it comes to workforce, particularly in construction.”
Fujifilm’s Holly Springs site is not Jacobs’ only ongoing life sciences construction project in the state, which Gerding called the hottest market in the U.S. In March, Johnson & Johnson broke ground on a new $2 billion biologics facility in Wilson, North Carolina, projected to add more than 5,000 manufacturing and construction jobs.
“We do have a lot of projects in North Carolina,” Gerding said. “We see investments particularly in biomanufacturing, cell and gene therapy, and various technologies. We support many clients on site selections. We’ve been in various states with clients when they look, and North Carolina still seems to top the list of places to build.”
However, Bill Bullock, senior vice president for economic and statewide development at NCBiotech, points out that some of these biomanufacturing construction sites employ thousands of people and technical talent is getting more difficult to find.
“The construction stuff’s real and we need to stay on top of that,” Bullock said. “It’s the champagne problem in a sense, but it’s real.”
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