ICF - Rivista dell'industria Chimica e Farmaceutica - International Issue 2026

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ANNOXVII NO4 2026SUPPLEMENT

INTERNATIONAL EDITION CPHI Milan 2026 | Special

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www.icfed.it

ANNOXVII NO4 2026SUPPLEMENT

INTERNATIONAL EDITION CPHI Milan 2026 | Special

INDUSTRIA CHIMICA E FARMACEUTICA RIVISTA DELL’

PVS_Eng_230_190.pdf 1 16/06/2025 10:33:22

icf Editorial

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The growing role of geopolitics in the pharmaceutical supply chain

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Cover story

A new approach to Quality

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MILAN AT THE HEART OF EUROPEAN PHARMA

News

Milan 2026 | Special

Research

20 Insights

Europe recognised life sciences as a strategic priority

12 Report

European Chemical Industry facing a widening capacity gap

The All-In-One supplier

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Hand disinfection made simple, safe and reliable

Technologies

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Advanced purification for life sciences

Containment solutions for today’s and tomorrow’s pharma

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Technology and research for pharmaceutical single-dose packaging

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100 years of expertise, looking ahead

AI, flexibility and a zero loss approach

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Technologies

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Chemical industry

CRBN decontamination kits: past, present and future of a increasingly strategic asset

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Advertising list

Colophon

Digital Transformation

Advanced technologies for injectable drug manufacturing

What Annex 22 spells for AI in GMP manufacturing

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Editorial

The growing role of geopolitics in the pharmaceutical supply chain by Alessandro Bignami

In recent years, the pharmaceutical supply chain has had to contend with multiple crises and the turbulence that has accumulated along the way. This persistent pressure has prompted a traditionally conservative industry to reassess its priorities and develop strategies to adapt to an increasingly unstable environment. Armed conflicts, rising energy and raw material costs, regulatory complexity, tariffs, and dependence on active pharmaceutical ingredients manufactured in China and India have put the sector under considerable strain. As a result, companies have been forced to rethink and implement new approaches to sourcing, manufacturing and building relationships across the market. These are likely to be among the key topics discussed in conferences, exhibition stands and the corridors of CPHI Milan, which will bring together leading players from across the international pharmaceutical supply chain in the Lombardy capital. How can the sector become more resilient? How can production be diversified, new alliances established and regulatory capabilities strengthened? The answers to these questions will play a significant role in shaping the future of the European pharmaceutical industry and the global sector as a whole. It is worth highlighting one emerging response that clearly illustrates the growing role of geopolitics in industrial decision-making: the shift towards nearshoring and friendshoring. These approaches involve

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establishing or relocating manufacturing operations closer to end markets and, increasingly, to countries that are more closely aligned from a geopolitical perspective. Signs of this trend can be seen in the growing number of North American pharmaceutical companies establishing manufacturing facilities in Mexico, European companies expanding production in Eastern Europe, and businesses setting up operations in Southeast Asia to serve Asia-Pacific markets. Tariffs, bureaucratic hurdles, regulatory differences, rising transportation costs and increasingly vulnerable global supply chains, exposed to international tensions, are encouraging companies to bring production closer to the markets they serve. This represents a significant countertrend to the expansion of globalisation that dominated industrial development for decades. Within the pharmaceutical sector, this shift is likely to further enhance the role of CDMOs. By offering major pharmaceutical companies access to local manufacturing facilities, knowledge of national regulations and market-specific manufacturing practices, as well as flexibility and specialised expertise, CDMOs can become strategic partners in the effort to build more resilient and geographically diversified supply chains. ICF will be at CPHI Milan to explore these and other developments together with the many players shaping a complex and strategic supply chain that is fundamental to both the global economy and global health.

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Cover story

A new approach to Quality The Quality Day 2026, organised by PVS and PTM Consulting, will explore a number of current topics in pharmaceutical manufacturing, including GxP regulations, Risk Management, predictive stability, Extractables & Leachables and validation.

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uality in the pharmaceutical sector is closely linked to companies’ ability to interpret regulatory developments, assess risks and integrate new approaches into manufacturing and organisational processes. It is in this context that the second edition of Quality Day will take place on 22 October 2026 at the Devero Hotel in Cavenago di Brianza, in the province of Monza and Brianza. The event, organised by PVS – Process Validation Service and PTM Consulting, offers a full day of indepth discussion focusing on GxP, Quality Risk Management, predictive stability, Extractables & Leachables and validation, with a programme alternating technical presentations and opportunities for discussion with participants. Attendance is free of charge, subject to online registration. A programme focused on the evolution of quality The first technical session will open with a presentation on GxP regulations by Fabio Geremia, Quality Director & QP at PVS Consulting, who will provide an overview of regulatory updates and the main developments in the regulatory framework. This will be followed by a discussion of one of the topics attracting growing interest within the pharmaceuti-

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cal industry: Extractables & Leachables in the upcoming ICH Q3E. The session will be led by Marinella Capuzzi, Industrial Development Manager at Italfarmaco, and Giorgia Romagnoli, Professional Consultant & Business Developer at PTM Consulting. The programme will continue with an in-depth look at the new ICH Q1, innovation and predictive stability. The session will be conducted by Stefano Selva, General Director at Mon-

teresearch, and Silvia Piersanti, Professional Consultant & Business Developer at PTM Consulting. The morning will conclude with a presentation on the evolution of Annex 15, with a particular focus on the impact of Risk Management and the new approach to validation. Speakers will include Nicolas Livraghi, Technical Director at PVS, and Francesca Speroni, Managing Consultant at PTM Consulting. The programme will continue in the

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Cover story Risk Management and Quality by Design PTM Consulting focuses on providing consulting services to companies in the Life Science sector, with an offering that includes Integrated Quality Risk Management, Quality by Design, Combination Products and Quality & GMP Support. As part of its Quality & GMP activities, PTM supports companies in managing Change Control, deviations, CAPA, Quality Agreements and audits of suppliers and con-

afternoon with an Open Session, designed as an opportunity for discussion and further exploration of the topics addressed during the day. GxP expertise for Life Science and process validation PVS – Process Validation Service operates in the field of GxP services for the Life Science sector, providing consulting, qualification and validation activities. Its areas of expertise include the qualification and requalification

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of plants and equipment, process validation, instrumentation adjustment and calibration, as well as activities relating to HVAC systems, utilities and classified environments. PVS’s approach focuses on managing the quality and compliance aspects associated with plants and manufacturing processes in regulated environments. Its activities also include qualification, periodic verification and documentation support.

tract manufacturers, as well as remediation and improvement projects and inspection readiness. The company also applies Risk Assessment methodologies to topics such as elemental impurities, nitrosamines, residual solvents and Extractables & Leachables. Particular attention is also paid to the relationship between Quality Risk Management and knowledge management.

A presentation on GxP regulations will provide an overview of regulatory updates and the main developments in the regulatory framework. The focus will also be on the evolution of Annex 15, with particular attention to the impact of Risk Management and the new approach to validation

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News

IMCD opens new Pharmaceutical and Food & Nutrition Technical Hub in New Jersey IMCD Group, a leading global partner for the distribution and formulation of speciality chemicals and ingredients, has opened its new Pharmaceutical Tech-

nical Centre and Food & Nutrition US Technical Hub in IMCD’s new offices in Allendale, New Jersey, USA. The new facilities are part of IMCD’s network of more than 80 technical centres globally. At the opening celebration, guests were able to tour the new application laboratories and observe firsthand a space where creative ideas are transformed into tangible proof-of-concept prototypes. Designed as a centre for technical development and knowledge sharing, the new facilities offer expanded laboratory capabilities for product innovation, alongside a dedicated learning space for technical seminars, workshops, and collaborative learning. The facilities bring together IMCD teams, customers and suppliers under one roof to collaborate on leading solutions across the pharmaceutical, nutraceutical, and food and beverage markets, accelerating the transformation of ideas into real-world solutions with greater speed and efficiency. The local facilities will benefit from state-of-the-art technical capabilities, connected to experts across the Global lab network via our digital analytics platform.

GSK enters agreement to acquire Nuvalent GSK plc last 9 June announced that it has entered an agreement to acquire Nuvalent, Inc., a Boston-based clinical-stage biopharmaceutical company focused on creating precisely targeted oncology therapies, for $10.6 billion. The acquisition is consistent with GSK’s strategy of acquiring assets that have validated targets and meaningfully address efficacy and/or tolerability limitations of existing standard-of-care therapies. It includes three products in lung cancer in a single transaction. Zidesamtinib (NVL-520) and neladalkib (NVL-655) are two late-stage, potential best-in-class, next-generation, highly selective ROS1 and ALK inhibitors for treatment of NSCLC. Both assets have received FDA Breakthrough Therapy and Orphan Drug Designations and are in review with target decision dates of 18 Septem-

ber 2026 for zidesamtinib and 27 November 2026 for neladalkib. Subject to FDA approval, they are expected to launch in 2026 and have multi-blockbuster potential. The third asset, NVL-330, is a potential best-in-class HER2 inhibitor currently in phase I trials for HER2-altered NSCLC. The acquisition also includes Nuvalent’s preclinical portfolio of multiple programmes, built from their proven precision medicine capabilities and clinical insights from industry-leading physician-scientists. Luke Miels, Chief Executive Officer, GSK said: “This acquisition is a multi-product deal, consistent with our approach to acquire assets that have clinically proven targets and meaningfully address an efficacy and/or tolerability gap. The two lead products are potential best-in-class assets that could launch this year if ap-

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proved by the FDA and offer significant new treatment options to patients with two forms of non-small cell lung cancer. The acquisition provides GSK with immediate new sales growth opportunities, improving profit contributions from 2027, and a platform in lung cancer for rapid expansion with Ris-Rez, our B7-H3 targeted ADC in phase III clinical development.” Pivotal data presented at the IASLC 2025 World Conference on Lung Cancer and the 2026 ASCO Annual Meeting show potential best-in-class profiles for zidesamtinib and neladalkib.1,2 Both assets aim for longer effective treatment with better quality of life through high target-selectivity, durable treatment response, improved tolerability, enhanced bloodbrain barrier penetration for tumour spread, and broader coverage of ALK and ROS1 mutations, potentially addressing efficacy and/or tolerability limitations of existing therapies.

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Report

European chemical industry faces a widening capacity gap Cefic’s first European Chemical Closures and Investments Radar highlights a growing imbalance between announced production shutdowns and confirmed investments, pointing to mounting pressure on Europe’s chemical manufacturing base.

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he European chemical industry is undergoing a significant shift in its production landscape. Between January 2022 and December 2025, companies announced the closure of at least 37 million tonnes per year (Mt/y) of chemical production capacity across Europe. Over the same period, only around 7 Mt/y of new capacity was confirmed through investment decisions, construction starts or completed projects. The resulting balance points to a potential net capacity reduction of approximately 30.2 Mt/y. According

to the first European Chemical Closures and Investments Radar, commissioned by Cefic and prepared by Roland Berger, the gap between closures and investments has widened considerably over the period covered by the analysis. Closures accelerate The trend in closures is particularly striking. Announced capacity earmarked for closure increased sixfold, from 2.9 Mt/y in 2022 to 17.2 Mt/y in 2025 year-to-date. The 2025 figure alone is more than twice the capacity announced for closure in 2024.

In total, the database records 126 closure announcements with known capacity between 2022 and 2025 YTD. The 37 Mt/y concerned corresponds to around 9% of Europe’s chemical production capacity. The report notes that the actual figure could be higher, as capacity information was not available for around 20% of closure announcements, although these cases generally involved smaller assets. Petrochemicals account for the largest share of the announced closures, representing 17.8 Mt/y, or 48% of the total. Basic inorganics follow with 11.7 Mt/y (32%), polymers with 5.4 Mt/y (15%) and specialty chemicals with 2.0 Mt/y (5%). The impact on Europe’s steam-cracking infrastructure is particularly significant. Nine steam crackers account for around half of the capacity announced for closure in the petrochemical segment, corresponding to a 16% net reduction in European steam-cracking capacity. All nine are located within integrated chemical clusters, increasing pressure on the wider ecosystems built around these facilities. Energy costs remain a critical factor The reasons behind the closures point to a broader competitiveness challenge. In 49% of the announcements

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Report analysed, companies cited a lack of energy cost competitiveness as the primary rationale for shutting capacity. Low demand was the second most frequently cited factor, at 19%, followed by overcapacity at 9% and regulatory factors at 8%. The issue is not concentrated in a single country. Germany accounts for 8.8 Mt/y, or 25%, of the capacity announced for closure, followed by the Netherlands with 7.2 Mt/y (20%), the UK with 4.5 Mt/y (12%), France with 3.9 Mt/y (10%) and Italy with 2.5 Mt/y (7%). Germany and the Netherlands together therefore represent around 45% of the announced capacity reductions. The consequences also extend beyond production assets. Around 20,000 direct jobs and an estimated 89,000 indirect jobs are cited as being affected by the announced closures across Europe. Investment is slowing At the other end of the equation, confirmed investments are moving in the opposite direction. New confirmed chemical capacity investments declined from 2.7 Mt/y in 2022 to just 0.3 Mt/y in 2025 YTD, for a total of approximately 7 Mt/y over the full period. The report identifies 99 confirmed investment announcements, of which 75 have known capacity. An additional 5 Mt/y of capacity has been announced but has not yet been formally confirmed through a final investment decision, construction start or completion. This means that announced, but not yet confirmed, projects could provide some additional capacity, although the report cautions that investment announcements do not necessarily materialise as initially planned. The decline is also visible in capital expenditure. Confirmed investment

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CAPEX fell from €7.6 billion in 2022 to €1.5 billion in 2025 YTD, an 81% reduction. Across 2022–2025 YTD, confirmed investment projects represented total CAPEX of approximately €13.5 billion. Petrochemicals remain the largest recipient of confirmed capacity investments, with 3.8 Mt/y, or 59% of the total. However, this represents only a partial offset to the 17.8 Mt/y of petrochemical capacity announced for closure. Specialty chemicals account for 1.7 Mt/y of confirmed investments, while polymers account for 0.6 Mt/y and basic inorganics for 0.4 Mt/y. New investment priorities The nature of the projects that are moving forward provides a further indication of how the European chemical industry is evolving. Demand outlook is the main driver behind confirmed investment CAPEX, accounting for €4.9 billion, or 36% of the total. Strategic decisions represent another 34%, while sustainability and regulatory compliance account for 26%. Three investment themes stand out: the battery value chain, emission reduction and recycling. Together, they account for around 40% of confirmed investment CAPEX. Battery-related projects represent €1.9 billion, emission-reduction projects another €1.9

billion, and recycling projects €1.5 billion. The geographical distribution of investments also differs significantly from that of closures. Belgium leads confirmed new capacity with 2.4 Mt/y, followed by Germany with 0.8 Mt/y and France with 0.4 Mt/y. These three countries account for 54% of total confirmed capacity investments. Belgium is also the only major chemical-producing country showing a slightly positive net capacity balance, supported by a relatively small number of large projects.

Source: European Chemical Closures and Investments Radar 2022-2025 by Roland Berger for Cefic

A structural challenge for Europe Taken together, the figures describe an increasingly asymmetric development. Announced closures are generally nearer-term decisions, typically occurring within one to two years, while investments tend to have longer time horizons of two to five years. This difference means that the current capacity gap could evolve differently as projects progress, but the direction of the announced pipeline remains clear. For European chemical manufacturers, the ability to maintain competitive production while financing the transition towards lower-emission and more circular technologies will remain central to the future shape of the industry.

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News

Lilly to acquire Merida Biosciences Eli Lilly and Company and Merida Biosciences, Inc., a biotechnology company advancing a new class of precision therapeutics for serious autoimmune and allergic diseases, today announced a definitive agreement for Lilly to acquire Merida. Merida is developing biologics engi-

neered to selectively degrade pathogenic autoantibodies, the disease-causing agents behind a range of immune-mediated conditions. The precision degradation approach is intended to address the biological cause of these diseases, rather than broadly suppressing the immune system, as many current therapies do. Merida’s lead program, MER511, is in Phase 1 development for Graves’ disease and thyroid eye disease (TED), conditions driven by thyroid-stimulating immunoglobulins, which are autoantibodies that activate the thyroid-stimulating hormone receptor. Graves’ disease affects approximately 3 million people in the U.S., and patients face elevated cardiovascular risk and mor-

tality. Roughly 25 to 40 percent of people with Graves’ disease go on to develop TED, which can cause pain, disfigurement, and in severe cases, vision loss. While there are approved treatments for both conditions, none directly target the autoantibodies that cause them. Because pathogenic autoantibodies drive a wide range of serious diseases, Merida’s platform has potential application well beyond its lead program. The company’s pipeline also includes MER769, a preclinical program focused on food allergy, asthma, chronic spontaneous urticaria and other diseases driven by the antibody responsible for triggering allergic reactions, along with earlier-stage programs in kidney diseases such as membranous nephropathy and other immune-mediated conditions.

Schülke and AM Instruments join forces to shape the future of life science Schülke & Mayr GmbH and AM Instruments announce the acquisition of AM Instruments, one of Italy’s leading specialists in contamination control and cleanroom solutions for the Life Science industry. The acquisition represents another important milestone in schülke’s Life Science growth strategy. AM Instruments complements schülke’s existing portfolio with a broad range of cleanroom consumables. Its strong technical capabilities, GMP-oriented culture, and highly customer-centric approach allowed AM Instruments to build an exceptional reputation across the pharmaceuti-

cal industry over the last thirty years. Together, our future organization will be uniquely positioned to support pharmaceutical and biotechnology customers across the entire contamination control value chain. This partnership is founded on a common vision, a similar entrepreneurial mindset, and a deep commitment to quality, innovation, customer focus, and longterm value creation. To ensure continuity for customers, partners and employees, Cinzia Pagani and Roberto Fossati will continue to support the company, working closely with the new organization during the next phase of its

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development. Patric Scheidner, Head of SBU Life Science at schülke “AM Instruments is exactly the type of company we were looking for to accelerate our Life Science strategy. Most importantly, we have found entrepreneurs who share our values and our ambition. Both organizations are driven by the belief that sustainable success comes from enabling customers to solve critical challenges through expertise, quality, and partnership. We are excited to write the next chapter of growth together.” Cinzia Pagani, President of AM Instruments “From the

very beginning, this process never felt like a conventional transaction. It felt like two organizations discovering how much they had in common and how much they could achieve together. We found in schülke a partner that understands our culture, respects our history, and believes in our vision.” Roberto Fossati, CEO of AM Instruments “Since founding AM Instruments, we have built the company around a simple idea: combining technical excellence with an unwavering focus on customer success. In schülke, we have found an organization that shares this philosophy”.

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News

Alnylam and Inceptive form strategic AI collaboration Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, and Inceptive Nucleics, Inc., which builds foundation models of life, today announced a strategic collaboration agreement to increase the pace of therapeutic innovation. The collaboration is valued at up to $2B with upfront consideration of $30M, including cash and the purchase of Inceptive equity. Inceptive is eligible to receive additional payments based on the achievement of preclinical, regulatory, and commercial sales milestones. By integrating Inceptive’s generative AI models with Alnylam’s R&D engine, Alnylam aims to accelerate the discovery of novel RNAi therapeutics as it advanc-

es ambitious pipeline expansion goals as part of its Alnylam 2030 strategy. “We’re thrilled to partner with Inceptive to push the boundaries of what is possible in the discovery of RNAi medicines,” said Yvonne Greenstreet, M.D., Chief Executive Officer of Alnylam. “Inceptive stands apart as one of the most visionary companies working at the intersection of AI and biology. It is led by pioneers of the AI revolution and driven by an ambitious mission to fundamentally reinvent how RNA medicines are designed. Together, we have an extraordinary opportunity to accelerate the creation of transformative medicines with a speed, ingenuity, and sophistication that sim-

ply has not been possible before.” Inceptive’s foundation model learns the patterns underlying biology and hence can adapt to diverse therapeutic modalities without retraining. “Most drug design still works through a process of trial and error, testing thousands of molecules and hoping something sticks,” said Jakob Uszkoreit, Inceptive co-founder and CEO. “Inceptive was built on a different premise: that life follows rules of such complexity that only AI can learn them. Alnylam’s breakthrough platform and scientific vision are an ideal match for AI. Together, we’re not just accelerating drug discovery; we’re changing the way we understand and improve life.”

Syntegon reported strong results for the first half of 2026 Syntegon, a leading strategic partner to the global pharmaceutical, biotech and food industries, reported strong results for the first half of 2026. Group sales increased 7 percent year-onyear to EUR 883 million, while adjusted EBITDA rose 16 percent to EUR 148 million. The adjusted EBITDA margin expanded to 16.8 percent, up 130 bps versus first half of 2025. Order intake reached EUR 964 million. A book-to-bill ratio of 1.09 and a record order backlog of EUR 1.3 billion provide a solid foundation for continued growth. “Our first-half 2026 results underline the positive impact of our strategy and the strength of Syntegon’s market position,” said

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Torsten Türling, CEO of Syntegon. “Our Pharma business remains our strongest growth engine. We achieved major new customer wins and market share gains in the expanding biologics market globally and in the United States in particular.” “Our first-half results demonstrate Syntegon’s strong operating leverage. Adjusted EBITDA increased more than twice as fast as sales, taking the margin to 16.8 percent,” added Eros Carletti, CFO of Syntegon. “This reflects the stronger earnings contribution from Pharma, operational discipline and continued improvements in project execution. Our solid order book provides a strong foundation for continued profitable growth and cash generation.” The pharmaceutical and biotech industries continue to benefit from structural growth drivers including the expansion of biologics and injectable medicines, and growing demand for more flexible and highly automated pharmaceutical production. Syntegon’s Pharma sales increased by 14 percent in the first half of 2026, making the business the strongest contributor to Group growth. Demand remained strong for aseptic Fill & Finish and isolator-equipped line solutions, supported by continued investment in biologics and injectable medicines as well as increasingly stringent regulatory requirements. Pharma Solid also delivered double-digit growth, driven by strong demand for innovative capsule-filling solutions and an expanded granulation product portfolio.

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News

Spain insulin pumps market to grow at 8% CAGR through 2036 Spain’s insulin pumps market is expected to witness steady growth, driven by the increasing prevalence of type 1 diabetes, growing adoption of advanced diabetes management technologies, and rising demand for automated insulin delivery systems. The shift toward personalized, data-driven diabetes care, supported by continuous glucose monitoring (CGM) integration and smart insulin delivery technologies, is accelerating the adoption of next-generation insulin pumps across the country. Amid these trends, Spain’s insulin pumps market is projected to grow at a compound annual growth rate (CAGR) of approximately 8% through 2036, according to GlobalData, a leading intelligence and productivity platform. Spain’s insulin pumps market is moving into a new growth phase as healthcare systems increasingly pri-

oritize technologies that reduce the day-to-day burden of diabetes management while improving glycemic control. GlobalData’s report, “Insulin Pumps and Continuous Glucose Monitors Market Size by Segments, Share, Regulatory, Reimbursement and Forecast to 2036,” reveals that Spain accounted for nearly 6% of the Europe insulin pumps market in 2025. Sarvesh Kumar, Medical Devices Analyst at GlobalData, comments: “As uptake of automated insulin delivery systems rises and connected diabetes care becomes more widely established, demand is expected to increase.” Within Spain’s evolving diabetes care landscape, the launch of Insulet’s Omnipod 5 marks an important step in expanding access to automated insulin delivery technology.

The introduction of a tubeless insulin pump integrated with compatible CGM platforms is expected to support broader adoption of closed-loop diabetes management by offering greater treatment flexibility and simplified insulin delivery. As reimbursement pathways and regional access continue to expand, the availability of advanced insulin pump technologies is likely to accelerate the transition towards connected, patient-centric diabetes care across Spain. Kumar concludes: “While the high cost of advanced insulin pump systems and regional reimbursement variations remain key barriers to wider adoption in Spain, continued improvements in automated insulin delivery are expected to drive greater insulin pump adoption and support long-term market growth.”

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News

Sanner brings all brands together Stefan Verheyden, CEO of the Sanner Group

Sanner, a leading global healthcare packaging and medical device CDMO, is rebranding its subsidiaries, uniting all offerings under the Sanner Group umbrella brand. In a first step, Springboard has now become Sanner UK. The transition from Springboard to Sanner UK marks a significant milestone following the acquisition through Sanner in January 2024. It underlines the shared vision to deliver seamless, end-toend solutions across the medical technology, pharmaceutical, and biotech value chain. By uniting under a single brand, Sanner strengthens its ability to provide customers with

a cohesive offering. “Our rebrand to Sanner reflects far more than a name change. It represents a deeper integration of expertise, culture, and ambition,” says Tom Oakley, founder of Springboard and VP Strategic Partnerships at Sanner. By bringing these capabilities together under one brand, Sanner is uniquely positioned to support customers throughout the entire product lifecycle. “This evolution reinforces our commitment to deliver intelligent healthcare solutions that improve lives,” says Stefan Verheyden, CEO of the Sanner Group. “With our strengthened pres-

ence across our global network, we are better equipped than ever to help our customers bring innovative healthcare technologies to market.” Springboard has built a strong reputation for solving complex technical challenges and delivering innovative solutions across regulated markets, supporting clients ranging from fast-growing startups to multinational healthcare companies. Located in Cambridge, one of the UK’s foremost hubs for medical technology innovation, the Sanner UK site plays a central role in the Group’s global CDMO strategy. The facility offers state-of-the-

art laboratories and workshops, enabling rapid prototyping, testing, and development across a wide range of medical device applications. The next step in this strategic integration includes the rebranding of Gilero, located in the U.S. and acquired by the Sanner Group in October 2024.

Angelini Pharma completes acquisition of Catalyst Pharmaceuticals Angelini Pharma S.p.A., international pharmaceutical company and part of Angelini Industries, announces today the completion of its acquisition of Catalyst Pharmaceuticals, Inc. Catalyst is now part of Angelini Pharma, integrating Catalyst’s portfolio and commercial infrastructure with Angelini Pharma’s expertise and products in Brain Health. The transaction provides the participation of funds managed by Blackstone, that will invest 1 billion euros in preferred equity, subject to customary regulatory clearances. CDP Equity has approved to invest around 1 billion euros through a capital increase to acquire a 23.5

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per cent stake in the common equity of Angelini Pharma. The investment, strongly supported by CDP Equity, underpins Angelini Pharma’s transformation into a global player in brain health and rare diseases. It accelerates its expansion into the US market through the acquisition of Catalyst and promotes a significant increase in investments in research and development, thereby strengthening the entire national pharmaceutical sector and fostering high-quality employment growth in Italy as well. The operation was financed with the support of BNP Paribas, acting as Sole Global Coordinator and Underwriter of the overall financing package, including

the bridge-to-equity, for Angelini Pharma. Morgan Stanley & Co. International plc is acting as sole financial advisor to Angelini Pharma in connection with the participation of Blackstone and CDP Equity. This acquisition marks a pivotal moment in the ongoing transformation journey that Angelini Industries – a company with more than 100 years of history – has been pursuing with a clear strategic vision over the past four years and establishes Angelini Pharma’s presence in the U.S. as part of a balanced growth strategy, that will continue to see Italy as a strategic reference hub for production and scientific research within the Group’s global operations.

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Research

Evotec and Odyssey Therapeutics enter AI-enabled R&D collaboration Evotec SE announced that it has entered a strategic R&D collaboration with Odyssey Therapeutics, Inc. to discover potential new treatments in autoimmune and inflammatory diseases. Under the agreement, Odyssey will leverage Evotec’s integrated data-driven discovery platform, advanced screening capabilities and AI-enabled data science technologies to discover and validate differentiated small mole-

cule drug candidates across multiple high-value disease targets. By combining high-throughput experimentation with machine learning-driven analysis, the collaboration is designed to accelerate the identification of validated hit series and enable the rapid progression of promising therapeutic programs with the potential to transform the standard of care. The collaboration combines Odyssey’s deep expertise in autoimmune and inflammatory disease biology with Evotec’s industry-leading discovery infrastructure and proprietary compound libraries. By bringing together complementary scientific and technological strengths, the companies aim to accelerate early-stage research and efficiently generate and advance new medicines.

Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, said: “Drug discovery increasingly depends on the ability to integrate deep disease biology with advanced experimental and computational approaches to drug discovery. This collaboration with Odyssey illustrates well Evotec’s strategy in applying integrated discovery platform technologies to complex disease areas where new approaches are urgently needed. Together, we aim to generate differentiated and validated starting points for Odyssey to develop into new therapies for autoimmune and inflammatory diseases.” Evotec is eligible to receive milestone payments based on the successful delivery of validated hit series for each target, aligning value creation with successful discovery outcomes.

ROBOTIC FILLING SOLUTIONS FOR SMALL BATCH AND CELL & GENE PRODUCTS

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Insights

Europe recognised life sciences as a strategic priority EFPIA’s position on the EU Multiannual Financial Framework 20282034: “MFF must now make Europe the place to invest.” by EFPIA* press office

E *The European Federation of Pharmaceutical Industries and Associations

urope’s capacity to discover, develop and manufacture medical innovation is central to its competitiveness, health security and resilience. The next Multiannual Financial Framework (MFF) should therefore translate the ambitions of the Competitiveness Compass, the Life Sciences Strategy, including the Biotech Act, into sustained investment across the full innovation journey, from excellent science to clinical development, regulatory readiness, manufacturing, deployment and patient access. The MFF stated focus on compet-

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itiveness translated into complementary Horizon Europe and the European Competitiveness Fund (ECF) is welcome. However, this intent is undermined by the lack of clearly ringfenced budget for health life sciences that puts into question Europe’s ability to implement competitiveness tools on the one hand, and by the corporate “CORE” tax that will weaken Europe’s attractiveness investments on the other hand. The final MFF must provide the scale, predictability and coherent, investment-friendly framework needed to close Europe’s widening innovation gap and make Europe a more attractive destination for globally mobile life science investments.

1. Ringfence an ambitious budget for health and life sciences Health and life sciences should receive a dedicated, identifiable and protected allocation in Horizon Europe and ECF commensurate with their contribution to Europe’s competitiveness, resilience and strategic autonomy. Funding should support not only individual technologies and products, but the ecosystem that accelerates and de-risks innovation across the value chain. Research and translation: support excellent science, collaborative research, networks and centres of excellence, and enable rapid translation of knowledge into tangible health solutions. Clinical and regulatory capacity: modernise multi-country clinical trial networks and strengthen the capacity of the European Medicines Agency and national regulatory networks for future health technologies to keep pace with other global regulators on speed of decisions. Data, digital and deployment: invest in interoperable health-data infrastructures, AI-enabled health innovation, advanced manufacturing and health-system readiness for new solutions. Patients and resilience: support prevention and management of chronic disease, sustainable patient par-

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Insights ticipation, equitable access and resilient health systems. 2. Choose investment over additional burden EFPIA opposes the introduction of Corporate Resource for Europe (CORE) lump-sum contribution which represents a high risk for Europe’s competitiveness. A tax linked to turnover would add to the cumulative burden on companies, and directly contradicts the EU’s competitiveness objective of attracting research and manufacturing investment. Pharmaceutical R&D and manufacturing investments are highly mobile, globally contested and planned over decades. Additional cumulative burdens would weaken Europe’s attractiveness precisely when the EU is trying to reverse the decline in its share of global biopharmaceutical R&D investment. A turnover-based charge may also bear little relation to profitability or ability to pay, disproportionately affecting research-intensive business models. 3. Keep the Competitiveness Fund and Horizon Europe open, collaborative and fit for purpose Horizon Europe should fund excellent collaborative research, translation and clinical development, including through European Partnerships and Part II, ‘Competitiveness and Society’, while the ECF should support scaleup, demonstration, advanced manufacturing and deployment. The two instruments should operate as a connected funding pathway across the innovation journey, without creating gaps, duplication or competing application processes. International collaboration and EU preference: Europe must attract the best knowledge, expertise and resources. EU-preference or economic-security safeguards should be ex-

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ceptional, targeted, proportionate and limited to entities receiving EU funding. IP and implementation: participants must retain control of results, licensing and confidential information. Horizon Europe should avoid health-specific exploitation obligations that could deter companies from contributing clinical studies and other valuable assets, such as proprietary data, to collaborative to projects and weaken the uptake of innovative SMEs. Simplification should reduce burden through fit-for-purpose rules and proportionate derogations, not an inflexible single rulebook. In particular, entities contributing in-kind to projects and not requesting any EU funding should be subject to a much simpler set of rules and obligations. 4. Enable strong public-private partnerships Public-private partnerships, including Joint Undertakings, combine EU funding with industry expertise, assets, data and long-term commitment, and should be able to connect research with ECF-supported scale-up and deployment. In-kind contributions are the cornerstone of public-private collaborative research: the framework must recognise financial and/or in-kind contributions without making cash the default. In IHI, industry contributes resources without requesting EU funding, creating genuine additionality. Fit-for-purpose partnership design: governance structures should reflect each partnership’s needs. Dedicated JU offices and flexible financial rules, including actual-cost reimbursement where needed, should be preserved. 5. Clarify governance and ensure policy coherence Governance should ensure transparent priority-setting, clearly defined

responsibilities between Horizon Europe and the ECF, and structured involvement of industry, patients and the research community in programme design and implementation. Funding decisions should reflect scientific excellence, unmet need, European added value and potential competitiveness impact. The Life Sciences Coordination Group could support policy coherence but should not replace fit-for-purpose governance and stakeholder participation within individual instruments and partnerships. EFPIA’s call to EU decision-makers The final MFF package should match Europe’s competitiveness ambitions with choices that reinforce investment: ringfence ambitious health funding in Horizon Europe and the ECF; preserve open, excellence-based collaboration; enable effective public-private partnerships based on inkind and/or financial contributions; establish coherent and inclusive governance; and reconsider CORE so that EU budget financing supports, rather than undermines, Europe’s long-term attractiveness for life-science investment.

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Technologies gases (VERISEQ® and A key player in technical gases and engineering ia-compliant Trace Pharma) for use in the phar-

Among Linde’s established technologies, the CUMULUS® heat exchanger stands out for its effective and reliable cooling of reactors and process equipment, together with CIRRUS®, a technology that allows for the reduction of up to 99% of VOC.

Cryogenic liquid nitrogen

Chemical reactor

CUMULUS® FTC system

Process fluid cycle Reusable gaseous nitrogen

Above: the CUMULUS® FTC (fluid temperature control) system for cryogenic cooling of process fluids. Below: CIRRUS® cryogenic condensing column at a pharmaceutical plant

Linde produces and sells all types of gases: oxygen, nitrogen, argon, acetylene, and mixtures, to sample gases, ultrapure gases. Not just gases, but also engineering. Over the years, Linde Gas Italia has gained experience in process technologies, especially in the “Chemistry” area. At its headquarters in Arluno (MI), staff is dedicated to the development of process technologies, individual products and plant engineering and maintenance. In particular, Linde Gas Italia provides its customers with its gas production, filling and distribution fa-

cilities, as well as extensive service coverage through its widespread network of sales outlets. The company’s gases are also used in the pharmaceutical and biotechnology sectors. Industrial gases are in fact employed at various stages of pharmaceutical manufacturing, where they contribute to the safety, efficacy and quality of products and active pharmaceutical ingredients. Process reproducibility, product consistency, compliance and cost savings are among the key benefits they provide. Linde supplies technical gases, high-purity gases and pharmacopoe-

CIRRUS® M150

Purified air

Gaseous nitrogen

Contaminated air Liquid solvents

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Cryogenic liquid nitrogen

maceutical and biotechnology sectors, including oxygen, nitrogen, carbon dioxide, hydrogen, argon and helium. The company has extensive experience in applications designed to protect valuable chemicals and ingredients. Through inerting, blanketing and purging techniques, Linde has supported numerous customers in implementing systems to create and maintain inert atmospheres. CUMULUS®, the exchanger for cryogenic cooling It is often necessary to reach very low temperatures for chemical synthesis or to remove rapidly the heat generated by an exothermic reaction. Linde has developed a cooling exchanger, called CUMULUS®, which enables heat exchange between liquid nitrogen at a temperature of approximately -196°C with a heat transfer fluid (HTF) (e.g., methylcyclohexane, Therminol®, Syltherm®). Cryogenic cooling allows temperatures to be reached as low as -100°C, ensuring a high level of control and safety. This technology helps improve productivity thanks to faster dosing, allows for the recovery of gaseous nitrogen in the plant network, and requires extremely little maintenance. CIRRUS®, technology for VOC abatement CIRRUS® technology allows for the reduction of up to 99% of VOCs in the gas stream using a cutting-edge cryogenic condensation process. This approach is effective when the vapor concentration exceeds 40 g/Nm³ and the process gas flow is less than 1000 Nm³/hour. It is a particularly suitable solution for the pharmaceutical, chemical, and petrochemical industries, as well as for chemical storage facilities.

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Exactly what you need. Powered by science, designed by humans. Universal Pack designs and manufactures high-end VFFS machines and complete lines for single-dose packaging in sachets and stick packs. Since 1965, it has been creating highly customized systems for the food, pharmaceutical, nutraceutical, cosmetic, and chemical sectors, guaranteeing precision, reliability and maximum efficiency for every type of product. CPHI Milan will be an opportunity to present Universal Pack's latest innovations: solutions designed to combine sustainability, high performance and total process safety. www.universalpack.com | info@universalpack.com

CPHI Milan 06-08 October 2026 Milan - Italy

Booth/Stand: 9J44

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Technologies

Modular Interface System

The new Modular Interface System (MIS) from icotek is an innovative solution for connecting cable management and industrial connectors. The system combines a split cable entry with the option of integrating 3A or 4A connectors directly into the frame. Suitable for this are 3A and 4A inserts from icotek and many other manufacturers. The cable entry enables the entry, sealing and strain relief of cables with and without connectors, with cable diameters from 1 to 15 mm, in accordance with DIN EN 62444. 3A or

4A industrial connectors are plugged directly onto the frame. The complete system consists of a frame with add-on housing for the socket insert, a cover, two screws and a locking element. The set also includes the counterpart, a housing for 3A/4A pin insert and a cable gland (M20 for 6-12 mm or M25 for 13-18 mm). The frame is CE compliant and compatible with numerous manufacturers, including Harting, Ilme, Phoenix Contact, TE Connectivity, Weidmüller, Lapp, Amphenol, Molex and RS Pro. Advantages Space saving: The combination of industrial connectors and cable entry avoids additional cut-outs, saving space. High protection rating: Protection rating IP65 is achieved thanks to the injected seal on the back. The IP65 degree of protection is maintained even when using double grommets. IP54 is achieved with the protective cover available as an accessory.

Simple installation: The cable grommets are automatically fixed in the frame. Once fully assembled, the cover is screwed on and the plug is locked into place with a clip. Flexibility: Compatible with a wide range of manufacturers and suitable for various industrial applications. Technical details Cable diameters: 1 - 15 mm Cable glands: M20 (6 - 12 mm), M25 (13 - 18 mm) Industrial connector sizes: 3A, 4A Protection classes: IP65, optional IP54 Standards: UL Type 12, DIN EN 62444 Accessories: unused connectors can be covered with an optional protective cover to ensure IP54 protection. The MIS is the perfect choice for applications where cable management and plug connections need to be integrated seamlessly and in a space-saving manner. The combination of functionality, protection and flexibility makes it a unique solution on the market.

Next-generation platform to boost efficiency in cell therapy production The life science group Sartorius is launching an integrated system for the production and quality control (QC) of autologous cell therapies. The modular Eveo Cell Therapy Platform is designed to address structural manufacturing bottlenecks that limit scalability and patient access to transformative treatments such as CAR-T therapies. With its latest innovation, Sartorius introduces a fundamentally new approach to cell therapy production that strengthens the company’s position in the dynamic advanced therapies market. Cell therapies are redefining medical possibilities. Yet, they remain accessible to only a small share of patients because manufacturing is complex, capacity-constrained and therefore expensive. With our integrated platform, we are tackling these struc-

tural bottlenecks head-on,” said René Fáber, member of the Executive Board at Sartorius. “By combining raw materials, production equipment, software and QC assays into a scalable system, we enable our customers to expand output, significantly reduce cost per dose and shorten vein-to-vein time for patients.” Conventional manufacturing models for autologous cell therapies rely on centralized, purpose-built facilities,

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that require significant greenfield investment, staff recruitment, training and multi-year build-up phases. Nevertheless, around 60 percent of regulatory disruptions in cell therapy production are caused by manufacturing and process-related issues. The new Eveo platform addresses these challenges by integrating cell selection, activation, gene modification, expansion, wash and concentration and final formulation into a closed system, using a variety of Sartorius solutions from critical raw materials to bioreactors and separation technologies. The system’s compact design supports implementation in existing facilities with existing staff, allows for operation in lower-classification environments and supports centralized and decentralized manufacturing models.

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INSIDE

BUILT AROUND THE PROCESS. DRIVEN BY INTEGRATION. Our solutions, our technologies, and our machines work as one to streamline your processes and boost performance. Discover the flow we bring to innovation. Visit us at CPHI WORLDWIDE 2026 Milan, ITALY • October 6-8 • Booth 9C2

imagroup.com

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Milan 2026 | Special

Milan at the heart of European pharma CPHI brings together the different stages of pharmaceutical production. The exhibition covers the supply chain from APIs and excipients through contract development and manufacturing, finished dosage forms and packaging, right through to equipment, services and logistics. of the 2026 edition is particularly significant. Pharmaceutical companies and their technology partners are facing increasingly complex challenges involving manufacturing efficiency, supply-chain resilience, sustainability, quality, regulatory compliance and the adoption of digital technologies. CPHI Milan aims to provide a space where these challenges can be discussed not only from a technological perspective, but also through partnerships and new approaches to the pharmaceutical value chain.

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rom 6 to 8 October 2026, Fiera Milano will once again become a global meeting point for the pharmaceutical industry as CPHI Milan brings together manufacturers, technology suppliers, service providers and experts from across the entire pharma supply chain. With more than 62,000 professionals expected and over 2,400 exhibitors, the event confirms its role as one of the industry’s most important international platforms for business, technological innovation and knowledge exchange.

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CPHI Milan is designed to provide a comprehensive overview of the pharmaceutical ecosystem, bringing together traditionally separate segments under one roof. Ingredients, contract manufacturing, finished dosage, packaging, drug delivery, machinery, equipment, laboratory technologies and specialised services are all represented, allowing visitors to explore both established solutions and emerging technologies while creating new business relationships. For an industry undergoing profound transformation, the timing

AI and digitalisation enter the production equation Among the new areas at CPHI Milan 2026, AI & Tech is particularly indicative of the industry’s current transformation. Artificial intelligence is progressively moving beyond experimental applications and into practical industrial processes, from drug discovery and clinical development to manufacturing, operations and commercial analytics. In manufacturing environments, the combination of artificial intelligence, advanced data analysis, automation and digital twins is opening the door to new approach-

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Milan 2026 | Special es to process optimisation and predictive maintenance. The objective is not simply to automate individual operations, but to make production systems more measurable, adaptable and capable of responding to changes in real time. For pharmaceutical manufacturers, this evolution also raises important questions concerning data integrity, validation, cybersecurity and regulatory compliance. These issues will be increasingly central as digital systems become more deeply integrated into critical production processes. The technological discussion will therefore extend beyond individual machines or software platforms. The focus will increasingly be on how digital technologies can be integrated into existing facilities while maintaining the high standards of quality and reliability required by pharmaceutical production. Machinery, equipment and advanced manufacturing The machinery and equipment segment remains a key component of CPHI Milan, providing an opportunity to examine the technologies supporting processing, manufacturing, inspection and packaging operations. The dedicated Machinery & Equipment area will showcase solutions aimed at improving productivity, flexibility, quality control and automation. The pressure on manufacturers to increase efficiency while maintaining consistent product quality is encouraging equipment suppliers to develop increasingly flexible systems. Shorter production runs, greater product diversity and the growth of personalised and specialised medicines require machinery capable of adapting rapidly to

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different products and formats. At the same time, inspection and monitoring technologies are becoming increasingly important. Automated vision systems, digital monitoring, process control and data collection are helping manufacturers identify deviations earlier and improve overall process reliability. Packaging represents another important element of this evolution. At CPHI Milan, packaging and drug delivery technologies will be examined not only in terms of containment and protection, but also in relation to usability, traceability, sustainability and patient needs. Sustainability becomes a strategic priority Sustainability will be another major theme at the 2026 edition. The CPHI Sustainability Summit will run alongside the exhibition on 6 and 7 October, bringing together sustainability leaders and decision-makers to discuss the environmental and social challenges facing the pharmaceutical industry. More than 300 sustainability professionals are expected to participate in interactive discussions, roundtables and working groups. The sustainability challenge for pharma is particularly complex. Manufacturers must reduce energy and resource consumption, minimise waste and emissions and improve the environmental performance of production and logistics, while continuing to comply with strict quality and safety requirements. This means that sustainability increasingly needs to be incorporated into the design of processes and equipment rather than treated as a separate objective. Energy-efficient machinery, resource optimi-

sation, waste reduction, more sustainable packaging and improved supply-chain management are consequently becoming important areas of technological development. The presence of sustainability within the main CPHI programme reflects this shift: environmental performance is increasingly becoming part of the wider discussion about competitiveness, innovation and long-term resilience. Milan, a strategic location The choice of Milan as the host city also reinforces the event’s strategic positioning. Italy has a significant pharmaceutical manufacturing base and a strong network of companies operating in production technologies, machinery, packaging, ingredients and contract services.

The machinery and equipment segment remains a key component of CPHI Milan, providing an opportunity to examine the technologies supporting processing, manufacturing, inspection and packaging operations

For international visitors, CPHI Milan consequently offers an opportunity to combine global networking with direct access to one of Europe’s important industrial and pharmaceutical markets. Over three days, Fiera Milano will become a concentrated representation of the pharmaceutical value chain: from raw materials and active ingredients to manufacturing, automation, packaging, logistics and digital technologies. The breadth of the event reflects the increasingly interconnected nature of pharmaceutical production itself.

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Milan 2026 | Special

Stainless steel, when quality makes the difference Not just stainless steel, but precision, control, and reliability. Based in Fiesco (CR), Italy, Aerre Inox Srl operates in the stainless steel sector serving various industrial industries, with specialized expertise in the pharmaceutical market, which represents the company’s main core business. Years of experience allow Aerre Inox to understand the needs of highly specialized markets and translate them

into concrete, reliable, and technically sound solutions. The product range includes heat exchangers, magnetic mixers, aseptic valves, and other stainless steel equipment, selected to meet different applications and quality standards. In the pharmaceutical sector, where control and compliance are essential, utmost attention is dedicated to material quality, traceability, and supply chain control. Production adheres to cGMP principles, and Aerre Inox is ISO 9001 certified, providing all necessary documentation for qualification and validation procedures. Depending on the application, EN 10204 3.1 material certificates, FDA and USP Class VI declarations, surface finish compliance documentation, as well as ATEX certifications according to Directive 2014/34/EU and PED according to Directive 2014/68/EU are available. From the province of Cremona, Aerre Inox looks to the world: its products are exported globally, supporting clients and partners with expertise, responsiveness, and punctuality. Booth 9D89

Nutraceuticals with high scientific value Labomar is an international CDMO platform specializing in the research, development, and contract manufacturing of dietary supplements, medical devices, pharmaceuticals, foods for special medical purposes, and functional cosmetics. Founded in 1998 in Istrana, in the province of Treviso, the Group has grown into one of the most diversified players in the European nutraceutical industry, driven by an integrated business model that combines scientific research, regulatory expertise, manufacturing capabilities, and innovation to support partners across the entire value chain. With eight manufacturing facilities across Italy, Spain, Canada, and Finland, and an increasingly strong international presence, Labomar develops high-value solutions designed to anticipate market evolution and meet emerging consumer needs The Group’s most significant innovation for 2026 is ChoLnexT 25™, its twentieth patent and first European patent developed as

an alternative to red yeast rice for cholesterol management. Created through a research project involving a multidisciplinary in-house team, ChoLnexT 25™ is produced entirely in Europe and combines two Mediterranean-derived botanical extracts. Its formulation simplifies dosing while providing a practical response to the evolving European regulatory landscape, offering nutraceutical brands an exclusive, effective, and clinically validated ingredient. A clinical study involving more than 100 participants demonstrated significant results, including a 10% reduction in total cholesterol, a 23% reduction in LDL cholesterol, and a 15% increase in HDL cholesterol. This achievement further confirms Labomar’s ability to transform scientific research into marketready solutions. Alongside ChoLnexT 25™, Labomar continues to expand its offering across several high-growth strategic categories. In the Women’s Health segment, the company is enhancing its portfolio with

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formulations designed to support women’s well-being at every stage of life. Significant efforts have also been devoted to developing a new magnesium-based product line. In the probiotics sector, Labomar is further strengthening its expertise through the integrated capabilities of Pharmia, enriching its portfolio with innovative solutions for microbiome and gut health. Booth 8C34

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Milan 2026 | Special

The All-In-One supplier IMA Pharma introduces the All-In-One supplier specialized in designing and manufacturing innovative machines and complete lines for the processing and packaging of pharmaceutical, nutraceutical and medical products.

C

PHI Worldwide brings together the entire pharmaceutical supply chain and stands as one of the most important events in the industry’s annual agenda. The Pharmaceutical and MedTech Divisions of IMA Group, together with their specialists, are pleased to guide you inside Pharma, introducing the All-In-One supplier

specialized in designing and manufacturing innovative machines and complete lines for the processing and packaging of pharmaceutical, nutraceutical and medical products. With a strong focus on innovation, IMA also delivers projects dedicated to digitalisation, sustainability, and customer service solutions, supporting the entire pharma eco-

system towards greater efficiency and responsibility. Innovations on display Following its world premiere at Interpack 2026, IMA Life will present the TILE-X line at CPHI Milan, where it will make its Italian debut. TILE-X represents a groundbreaking innovation in the fill-finish process, designed

VPHP BioIndicator, D-value studies

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Milan 2026 | Special TILE-X with NEBULA

to handle Ready-To-Use components through magnetic levitation technology. Suitable for high-value pharmaceuticals such as biopharmaceuticals and ATMPs with a focus on Cell & Gene therapies, TILE-X extends the concept of modularity, unprecedented in the aseptic fill-finish process. Based on magnetic levitation technologies, TILE-X enables frictionless component handling with zero risk of particulate generation. At the IsoTech Lab - a corner devoted to the Isolator Research & Development Laboratory - IMA Life experts in aseptic processing will present the new IMA VPHP BioIndicator. Developed to complement Microbiological Support Services, this new generation of biological indicators has been specifically designed for VPHP bio-decontamination cycles used in isolators. IMA VPHP BioIndicator supports Cycle Development, Performance Qualification (PQ), re-qualification, and ongoing contamination control strategies, ensuring robust and defendable 6-log sporicidal performance. These biologi-

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cal indicators are based on Geobacillus stearothermophilus spores (ATCC 12980) and packaged in VPHP-permeable packaging. On show also the X-PEN LAB, a precise semi-automatic solution for clinical trials and small-scale production. It ensures accurate press -in with monitored force-distance measurement and supports multivariant manufacturing with manual loading and offloading. Ideal for early-stage development, X-PEN LAB belongs to the X-PEN Series: IMA MED-TECH’s standard platform for pen and autoinjector final assembly. The X-PEN platform, based on a Linear Magnetic Transport System (LMTS), supports multi variant manufacturing with production speeds ranging from 40 to 160 ppm. Integrated options include vision inspection, no-glassto-glass PFS handling, force-distance controlled assembly, priming and labelling. Inside IMA Pharma IMA Pharma is composed of highly expert divisions able to offer tailor-made solutions for the

most sophisticated requests of the pharmaceutical market: IMA Active (Solid Dose Solutions), IMA Life (Aseptic Processing & Freeze Drying Solutions), IMA Safe (Packaging Solutions), IMA BFB (End of Line Solutions) and IMA MED-TECH (Technologies for Medical Devices). Together, they combine unique skills and knowledge where people, equipment and technology come in perfect synergy. IMA Active offers a complete range of machines for the processing of oral solid dosage forms: granulation equipment, tableting machines, capsule filling machines with a wide range of filling and control systems, capsule and tablet coating machines in perforated pan and solid wall, capsule and tablet weighing machines, product handling and washing systems. After years of study and observation, IMA Active has also taken steps towards Continuous Manufacturing, revolutionizing the future of pharmaceutical technologies for OSD forms. In May 2021, IMA finalized the acquisition of the American Company

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Milan 2026 | Special X-PEN LAB

Thomas Engineering (now Thomas Processing), leader in the coating sector from over 50 years. Thomas Processing aims to become the overseas Center of Excellence for coating under the auspices of IMA Active. IMA Life, which includes the production sites of IMA Life Calenzano, IMA Life Pharmasiena, IMA Life North America, IMA Life Beijing and IMA Life Shanghai, offers a comprehensive product portfolio to process liquids and powders in aseptic and non-aseptic environments. Its offering includes vial and ampoule washers, depyrogenating tunnels, decontamination technologies, and filling and closing machines for ampoules and for Ready-to-use vials, syringes and pre-capped cartridges for medium and high-speed production. The portfolio also encompasses gloveless technologies for ATMPs, Cell and Gene therapies and radiopharmaceuticals, as well as powder

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microdosing and macrodosing systems, capping machines and a full range of containment solutions, including Restricted Access Barrier Systems and isolators, further strengthened by IMA ProSys technologies for containment and isolator systems. IMA Life also offers lyophilisation process development and continuous aseptic spray freeze drying technology, together with industrial, pilot and laboratory freeze dryers and automatic or semi automatic vial loading and unloading systems for freeze dryers. Last but not least, assembly and labelling machines for syringes, labelling machines for vials, ampoules, shaped containers, pre filled pens, Blow Fill Seal single dose containers and cartons with the latest serialization technologies. Blowing machines, depackers, tray loaders and other ancillary equipment are also available. IMA Safe, which includes IMA Safe Swiftpack, IMA North Ameri-

ca (IMA Safe Nova), IMA Safe Comadis, Omas Tecnosistemi, IMA Sarong, IMA Safe PG and Perfect Pack, specializes in designing and manufacturing complete lines for primary and secondary packaging in the pharmaceutical, nutraceutical and cosmetic industries. The IMA Safe division offers a comprehensive range of machines for blister packaging, capsule and tablet counting, sachet and stick packaging, tube, bottle and jar filling and capping, as well as machines for suppositories, ovules, and liquid unit dose form, fill and seal applications, and cartoners. IMA BFB is a leading provider of end-of-line packaging solutions for the pharmaceutical and healthcare industries. Its comprehensive portfolio covers stretch and shrink wrapping, overwrapping, case packing, palletizing, and robotic handling systems for medical devices. To ensure a seamless and fully integrated packaging process, IMA BFB also incorporates advanced IMA Labeling solutions for bundles, cases and pallets, delivering enhanced traceability, efficiency and operational performance across the entire end-ofline. IMA MED-TECH, part of IMA AUTOMATION, specializes in innovative medical assembly technologies. Offering turnkey solutions for the assembly of medical devices, including drug delivery injectors, inhalers, in vitro diagnostics, pointof-care solutions, wearables, pharma caps and complete processing and packaging lines for contact lenses and ophthalmic inserters, IMA MED-TECH provides high-precision systems for both standard and custom solutions.

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26.06.2026 15:03:23 21/09/26 15:46

Milan 2026 | Special

Hand disinfection made simple, safe and reliable At the fair, AM introduces ADACTA, the new automatic gloved-hand disinfection device. It allows the use of alcohol-based disinfectants in their original 1-liter trigger-spray bottles, already validated for cleaning and disinfection procedures in cleanrooms. On the occasion of CPHI 2026, AM introduces ADACTA, the new automatic gloved-hand disinfection device. Since 1990, AM has been a benchmark in contamination control for the Life Sciences sector, and with ADACTA it addresses the need for simplicity, safety, and reliability in a critical and essential operation within contamination-controlled environments. ADACTA is a practical solution designed for maximum operational efficiency. First and foremost, it allows the use of alcohol-based disinfectants in their original 1-liter trigger-spray bottles, already validated for cleaning and disinfection procedures in cleanrooms. The disinfectant is automatically dispensed directly from the original bottle, without the need for refilling or handling by the operator, significantly reducing the risk of cross-contamination. Furthermore, thanks to the patented systems developed by the manufacturers, the in-use sterility of the product is ensured, as it always remains in its original packaging.

A fully automatic and touchless system The system is fully automatic and touchless. It is equipped with a hand-position detection sensor capable of recognizing gloves of any color, ensuring precise, controlled, and repeatable disinfectant dispensing. The number of dispensing cycles can be customized, allowing the disinfection process to be tailored to specific operating procedures and different environmental criticality levels. The device is also equipped with integrated status indicators that enable real-time monitoring of the machine’s operating condition, clearly signaling the correct execution of the dispensing cycle, any malfunctions, or maintenance requirements. This feature contributes to improved process control, operational safety, and system uptime. High resistance to corrosion and to the disinfectants Manufactured entirely from AISI 304 stainless steel, ADACTA ensures high resistance to corrosion and to the disinfectants commonly used in cleanrooms. It provides long-term durability and full compatibility with contamination-controlled environments. Its compact design, free from critical edges and corners, facilitates cleaning and sanitization activities, helping reduce operating time and minimizing the risk of contaminant accumulation. A dedicated floor stand is also available, allowing for stand-alone installation and providing additional flexibility of use, even in environments with limited space or complex layouts. Once again, AM effectively responds to the operational needs of controlled environments with a solution that is as simple as it is effective. Booth 9H18

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Milan 2026 | Special

The basis of quality in nutraceutical production In the nutraceutical industry, product quality begins long before the production stage. It starts with the accurate dosing of ingredients, a critical step in which precision, repeatability and traceability are essential to ensure the integrity of every recipe and consistent quality across every batch. Even minimal variations can affect the characteristics of the final product, making it essential to use technologies capable of eliminating the variability typically associated with manual operations. Automated weighing processes make it possible to standardize operations, reduce the risk of human error and ensure consistent results over time. This not only means greater process reliability, but also a significant reduction in waste, more efficient use of raw materials and complete traceability of every operation performed. These benefits are complemented by safer

and more hygienic working environments, thanks to controlled powder handling and reduced direct contact between operators and ingredients. For laboratory activities, precision becomes even more critical. This is where TD-MATIC comes into play: the automatic powder weighing system developed by Lawer for laboratory-scale recipe preparation. TD-MATIC automates the dosing of small quantities of powder through a weighing station with a resolution of up to 0.001 g, managed by a three-axis robotic system that automatically handles mini-silos and containers. This configuration enables extremely accurate and highly repeatable dosing, accelerating research and development activities and ensuring that each formulation can be replicated with maximum reliability. Automating the weighing

process also frees operators from repetitive tasks, allowing them to focus on higher-value activities. Since 1970, Lawer has been designing and manufacturing automatic systems for the weighing and dosing of powders and liquids for a wide range of industrial sectors, including nutraceuticals. Booth 9F115

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Milan 2026 | Special

Advanced purification for life sciences BEA Technologies aims to establish itself as a supporting manufacturer in the global supply chain of filters and filter elements for the biotech processing and pharmaceutical industry. BIOKLARIS e NOVATRAK - Sterilizing membrane filters

Qualikap Single-use filtering capsules

In the dynamic world of the pharmaceutical industry, constantly evolving in terms of innovation in the production process and filtration materials, BEA Technologies Spa, led by Roberto Bea, stands out with over sixty years of experience in the purification of water, process solutions, liquids and compressed gasses with personalized solutions for many companies. The pharma-grade filter elements are carefully assembled in cleanrooms with controlled atmospheres, ensuring cleanliness and quality throughout the manufacturing process. The filters equipped with sterilizing membranes undergo pre-flushing with pyrogen-free water to eliminate processing residues and any possible contaminants. In 1981, BEA Technologies was

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among the first companies in Italy to implement a cleanroom for filtering element production later expanded in 2011. Following a major investment in 2024 the cleanroom doubled in size and productivity demonstrating BEA Technologies’ mission to become a major player in the life science filtration. BEA Technologies aims to establish itself as a supporting manufacturer in the global supply chain of filters and filter elements for the biotech processing and pharmaceutical industry, with an already well-established presence in Europe and around the world; considering that BEA Technologies has already developed an international distribution network in Europe, America, and Asia. Filtration for pharmaceutical production processes It is important to use the correct filtration systems for the microbiological stabilization and sterilization of products and solutions, preserving their key characteristics and properties while simultaneously ensuring the removal of suspensions, colloidal particles, and all other unwanted particles. The purification process will guarantee compliance to specifications. For the most demanding applications BEA Technologies has achieved excellence with NOVATRAK and BIOKLARIS filtering cartridges. BIOKLARIS are the ideal solution for sterilizing final stage filtration with optimized PES membrane and fully integrity testable. NOVATRAK filter elements, the lat-

est innovation in BEA Technologies’ product portfolio, are renowned for the incorporation of nanofibers, the best protection for sterilizing membrane filter elements. With the growing interest in single-use systems BEA Technologies is presenting al CPHI Milan 2026 a series of improvement and innovations in the line of QUALIKAP filtering capsules, for clarification and sterilization of pharmaceutical and biological products. The improvements of capsules QUALIKAP are specified to match the high critical requirements for disposables and point-of-use filtration for liquid solutions and gases. Designed with finite element analysis, they can resist a wide range of mechanical and physical stress, from pressure to themal shocks, to guarantee the highest level of security. The basic polypropylene housing contains a welded pleated filter element which can incorporate different filter media and membranes depending on the specific application of the capsule. The body is assembled using a new thermowelding process which guarantee a perfect sealing resisting to repeated mechanical stress and thermal sterilizations. The housing is completed with 2 vent and drain valves which are easy to use even with gloves and provide full vent and drain of internal process liquid. All materials used in construction meet the FDA requirements and are BIOSAFE. Booth 9h71

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Smarter data. Safer pharma operations. Octave connects fragmented systems to deliver real-time, actionable insight across the pharma asset lifecycle.

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Milan 2026 | Special

100 years of expertise, looking ahead At CPHI, Faravelli will continue the celebrations for its Centenary with the international pharmaceutical community, customers and partners. more than 400 guests gathered in Milan to celebrate a century of Faravelli. At CPHI, the celebrations will continue with the international pharmaceutical community, customers and partners. The event will also showcase Faravelli’s international dimension. Alongside the Italian Pharma team, colleagues from Germany, Spain – with Deltapharma – the Czech Republic and China will come together at the stand, bringing expertise, market knowledge and different perspectives from across the Faravelli Group. This international presence reflects the evolution of a company that has been working alongside its customers since 1926, continuously expanding its expertise, portfolio and geographical reach.

Luca Benati, CEO of Faravelli

CPHI Milan 2026 will be a very special occasion for Faravelli Group. This year, the Italian family company celebrates its Centenary and will bring the spirit of its 100th anniversary to Stand 1A84, with a bold, high-impact space designed to shine and look firmly towards the future. The milestone was officially celebrated on June 5, 2026, when

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A long-standing expertise in pharmaceutical ingredients Excipients have long been at the heart of Faravelli’s presence in the pharmaceutical industry. Over the years, the company has developed extensive expertise in the distribution of excipients for solid, semi-solid and liquid dosage forms, building strong relationships with leading international manufacturers and supporting pharmaceutical companies with carefully selected ingredients, technical know-how and regulatory expertise. In 2021, the acquisition of Deltapharma S.L.U. marked a further strategic step in this journey, ex-

panding Faravelli’s pharmaceutical portfolio to include APIs (Active Pharmaceutical Ingredients) and strengthening the Group’s ability to provide an increasingly comprehensive service to the industry. Because high-quality raw materials are essential, but they are only the beginning: in an increasingly competitive and complex market, standing out takes more. It takes the right strategic partner: knowledgeable, rigorous and reliable. A partner with a clear vision, able to understand specific needs and translate them into tailored solutions. This is where Faravelli’s approach makes the difference. Quality, service, expertise and reliability are the “right ingredients” the company brings to every partnership. From carefully selected excipients and APIs to technical and regulatory expertise, dedicated service and specialised support, Faravelli works alongside its customers to turn their needs into advanced, effective and safe solutions that deliver tangible results. At CPHI Milan, Faravelli will bring together a century of experience and a clear vision for what comes next. At CPHI Faravelli’ stand will not be about looking back: it will be a bright, distinctive expression of what 100 years of experience mean today and of Faravelli’s ambition to keep moving forward together with customers, partners and its international teams. Booth 1A84

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21/09/26 21:03 15:51 16/09/26

Milan 2026 | Special

80 years of scientific expertise

On the right: the Fidia Farmaceutici headquarters in Abano Terme, Padova

Founded in 1946, Fidia Farmaceutici is an Italian company and world leader in the research, development, production, and marketing of hyaluronic acid and its derivatives, which have earned it a leading position in viscosupplementation worldwide. Fidia’s mission is to improve people’s quality of life through innovative therapies that respond effectively to the needs of doctors and patients in strategic areas such as joint care, skin care, eye care, specialty care, and health & wellness care. With research and development laboratories in Abano Terme (PD) – where the company is based – and an additional research unit in Noto, Sicily, Fidia invests heavily

in innovation and boasts an internationally recognized scientific tradition. The Group has over 1,500 patents, of which more than 1,250 are dedicated to hyaluronic acid in various formulations and molecular weights. In addition to its headquarters, Fidia also has offices in Lombardy and Marche. With a strong focus on internationalization, Fidia distributes its products in over 120 countries thanks to a consolidated network of partners and distributors and commercial branches in the main world markets, including Austria, Bulgaria (branch), Egypt, France, Germany, Moldova, Poland, the United Kingdom, the Czech Republic, Romania, Russia, Slovakia, Spain, the United States, Switzerland, Turkey, and the MENA region. Today, the Group has over 1,700 employees and a turnover of more than €538 million (2025), of which approximately 50% is generated abroad. In 2026, Fidia celebrates 80 years of scientific expertise, transforming decades of research and innovation into solutions that improve true people’s quality of life, with an ever-evolving direction. Booth 20F2

From science to solutions IMCD brings its formulation expertise to the forefront, showing how scientific complexity can be transformed into tangible opportunities for pharmaceutical innovation. Under the theme “From Science to Solutions. Faster. Smarter. Patient-focused.”, IMCD positions itself as a strategic development partner, helping manufacturers overcome formulation challenges, accelerate time to mar-

ket, and deliver robust solutions designed around evolving patient needs. At the core of this approach is IMCD’s global network of Pharmaceutical Technical Centres, where scientific expertise, in-depth ingredient knowledge, and market insight come together to create practical, scalable formulations. This integrated model supports customers throughout the development journey, from excipient selection to formulation optimisation, manufacturability, and commercial scale-up. Within the CoLab Corner, a dedicated solutions hub on the IMCD booth at CPHI Milan, this expertise is demonstrated through six formulations and ready-to-use kits. These solutions have been developed to address real industry challenges while reducing development risks and timelines. Among them are two advanced extended-release (ER) generic drug development plat-

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forms: a bilayer tablet combining canagliflozin and metformin hydrochloride, and an upadacitinib ER tablet. Developed using a science-driven, risk-based formulation approach, these technical packages address key challenges including robust pH-independent release, consistent 24-hour therapeutic performance, and resistance to alcohol-induced dose dumping. Designed with scalability, manufacturability, regulatory readiness, and comprehensive technical documentation in mind, these solutions enable faster development and de-risk generic product launches. During the show, daily live demonstrations on mucoadhesion technology and modified-release formulations also offer direct engagement with IMCD’s technical experts, showcasing how collaborative science turns complex formulation challenges into faster, smarter, and truly patient-focused solutions. Booth 1B18

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s4s

S 4 S Where safety isn’t optional: tailor-made environments for pharma with guaranteed contamination control Engineering | Design | Planning | Construction & Commissioning Equipment & Validation | Turnkey | Utilities | Equipment Cables & Piping | Support & Maintenance

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25/06/25 15:51 18:28 21/09/26

Milan 2026 | Special

Containment solutions for today’s and tomorrow’s pharma In Milan, Iteco Engineering will present its vision of containment: technology, safety, and customization at the service of the pharmaceutical industry. In the pharmaceutical sector, safety, quality, and process control are increasingly interconnected. The manipulation of active substances, powders, potentially hazardous compounds and sensitive products requires work environments designed to ensure high levels of containment while simultaneously protecting the operator, the environment, and the product. This is where Iteco Engineering’s expertise comes into play. Since 1987, the company has been dedicated to the design and manufacture of isolators, glove boxes, and containment systems for pharmaceutical and laboratory applications. Iteco Engineering is an Italian company specialized in the design and construction of controlled-atmosphere glove boxes, pharmaceutical isolators, shielded isolators, and special solutions for the manipulation of highly active, chemical, toxic, and radioactive materials. Over the years, the company has developed a strongly customer-oriented approach, combining its standard product range with the ability to design and manufacture custom systems, developed around each customer’s specific requirements. For R&D and QC laboratories, Iteco offers the RD line, a range of isolators designed to create a confined and controlled working environment, ensuring simple and safe operations. Main features: AISI 316L stainless steel structure; filtration system with double absolute filter and automatic efficiency monitoring; 0.2 mm thick gloves providing excellent tactile sensitivity; smooth passthroughs and integrated multi-cable port; HMI touchscreen interface for system control, with acoustic and visual alarms (SCADA integration); inertization system and multi-cycle operating system. Alongside its isolators, Iteco also offers the

SGS Glove Box line, designed to meet a wide range of application requirements. The working chambers can operate under both positive and negative pressure and can be configured for different operating cycles, ensuring maximum safety in every operating environment. These systems are designed to comply with current ISPE guidelines, achieving containment levels up to OEB 5 and OEB 6, according to SMEPAC testing. Iteco’s portfolio also includes customized solutions for specific pharmaceutical applications, ranging from powder weighing and manipulations to systems dedicated to processes requiring an inert atmosphere, hu-

midity control, ATEX conditions, or specific containment requirements. The goal is not simply to develop a machine, but rather a fully integrated system that becomes part of the customer’s process. Glove Integrity Test The Glove Integrity Test is a solution designed to support pharmaceutical companies in verifying glove integrity in compliance with the requirements of EU

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GMP Annex 1. At CPHI Milan, at the Iteco booth (Hall H09 - Stand 9H60), Iteco will also present the MGC TLW Glove Integrity Test System, a solution specifically designed for glove integrity testing. Testing is performed directly on the glove, without the need to remove it from the isolator/glove box, thereby maintaining the integrity of the containment barrier. The system performs a pressure-decay leak test, allowing small leaks to be detected that may not be visible during a simple visual inspection. Particular attention is also paid to test traceability and data management, with automatic recording of all activities and report generation. At CPHI Milan, Iteco Engineering will therefore present its vision of containment: tech-

nology, safety, and customization at the service of the pharmaceutical industry. For Iteco, innovation means starting from the customer’s real needs and transforming them into containment solutions that provide maximum protection for the operator, product, and environment, without compromising practicality and comfort throughout all work activities. Booth 9H60

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Milan 2026 | Special

AI, flexibility and a zero-loss approach Steriline will showcase a robotic filling line that improves production efficiency, combining high process flexibility with the zero-loss concept and full compliance with Annex 1. Steriline, a company highly specialised in the manufacture of complete lines for the sterile filling of injectable and ophthalmic products for pharmaceutical companies worldwide, will be exhibiting at the next edition of CPHI. At the Steriline stand (Hall 9, Stand 9A58), visitors will be able to see the capabilities of the new VKSFCM11 robotic filling line, an ideal solution for all pharmaceutical companies seeking to improve production efficiency, combining high process flexibility with the zero-loss concept and full compliance with Annex 1, thanks also to the integration of state-of-the-art Artificial Intelligence (AI) applications. The VKSFCM11 robotic solution under an isolator, which will be presented at the stand – ideal for small batches and for cell and gene therapies – incorporates the new OmniAI Vision system, a platform developed by Steriline based on the integrated use of cameras and AI-driven data management and processing. This improves compliance with Annex 1 by making the line’s design more efficient, reducing the number of sensors and cameras within it

and optimising the laminar flow. “Thanks to AI, we can analyse images from the cameras positioned within the production line,” says Alessandro Caprioli, Product Development Director at Steriline. “These cameras, situated away from the filling, capping and crimping area, adhere to the ‘first air’ concept, provide wider fields of view and enable us to monitor a greater number of functions, offering clear benefits for our customers.” Designed to process products with high added value The VKSFCM11 is one of the solutions designed to process products with high and very high added value, regardless of the type of container. Thanks to its flexibility, it is also ideal for the study, research and development phases, as well as for pilot batches and small production runs. “The solution we are showcasing at CPHI 2026 is perfectly in line with the aim that has long distinguished Steriline, namely to offer increasingly future-oriented solutions capable of responding precisely to the demands and needs of

an ever-evolving market such as the one we serve,” says Federico Fumagalli, Chief Sales Officer at Steriline. “For this reason, Steriline has been developing AIbased applications for some years now, and the VKSFCM11 is the most recent and concrete example of this.” “We are proud to showcase this solution to visitors from all over the world; it combines the ‘zero-loss’ approach, a high degree of flexibility, and the integration of Artificial Intelligence,” says Giovanni Panzeri, Sales Area Manager at Steriline. “The VKSFCM11 is particularly interesting because, first and foremost, it meets all the requirements of Annex 1; furthermore, the integration of AI enables the analysis of a greater volume of data, thus allowing different checks to be carried out simultaneously but at a significantly lower computational cost.” At CPHI 2026, alongside the new OmniAI Vision system, OptiLAIN will also be unveiled – a platform dedicated to the continuous monitoring of the overall condition of the line and predictive maintenance. The two technologies complement each other perfectly and work in synergy: OmniAI Vision monitors the process from the outside, via cameras, while OptiLAIN monitors it from the inside, using all the other sensors. Booth 9A58 1: Remotely positioned cameras enable optimal one-way video streams 2: The use of robotics and AI allows for great flexibility and reduces the risk of contamination

1

2

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At the Heart of Your Process

Since

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Milan 2026 | Special 1

1 1: NSY 200 monoblock machine for the automatic inspection of syringes 2: Predictive Maintenance

Advanced technologies for injectable drug manufacturing Pharma, Aseptic and Digital: a selection of machines developed by the Marchesini Group’s various companies to meet the evolving needs of the pharmaceutical industry will be on display. Marchesini Group, a leading manufacturer of complete packaging and filling lines for the pharmaceutical and cosmetics industries, will participate in the next edition of CPHI Worldwide, taking place in Milan from 6 to 8 October 2026. This year’s spotlight will be on the Group’s Pharma and Aseptic Business Units, two strategic divisions that represent Marchesini Group’s excellence in pharmaceutical packaging and advanced technologies for injectable drug manufacturing. At Stand 9A2, Hall H09, visitors will discover the latest innovations, including a monoblock system for syringe inspection and a compact machine for the automated filling and closing of vials, syringes and cartridges. These solutions will be complemented by systems designed for small-scale production and laboratory applications, developed by Dott. Bonapace, a Group brand that will celebrate its important 80th anniversary during the exhibition. A dedicated area will also be devoted to digital transformation, where visitors will have the opportunity to explore the potential of Morpheus, the predictive maintenance system designed to optimise produc-

tion performance and enable customers to manage installed machines in an increasingly informed and efficient way. Among the key events ahead of the exhibition, visitors should not miss the joint presentation by Marchesini Group and SEA Vision, the Group company specialising in vision systems. On 7 October, from 2:45 p.m. to 3:10 p.m., at the Packaging & Device Innovation Theatre, the two teams will showcase their latest innovations in Automated Line Clearance, a key technology for improving automation and efficiency in pharmaceutical production lines. Technologies on display The exhibition area will feature a selection of machines developed by the Group’s various companies to meet the evolving needs of the pharmaceutical industry. Highlights include: - The NSY 200, developed by CMP Phar.ma, is a monoblock machine for the automatic inspection of syringes, equipped with an integrated denesting and renesting unit. Thanks to robotic handling, syringes are transferred to the inspection module in a single row, preventing any contact between them or with metal components. The inspection section can accommodate up to 10 inspection stations, making it possible to control every syringe area, including the flange, stopper, particle detection, fill level, needle shield, glass wall defects,

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and container integrity through HVLD (High Voltage Leak Detection) technology. The machine also features four customisable rejection lanes for the management of non-conforming syringes. - Manufactured by U.S.-based partner AST, GENiSYS® C is a fully featured fill and close platform with a small, cartbased operational footprint. With the same technology found on AST’s advanced, larger lines, GENiSYS® C has all the power of our innovative solutions for the full scope of drug development, from discovery to commercial distribution. - Among Dott. Bonapace’s key innovations on display will be an OEB5-contained capsule filling machine integrated with an isolator, capable of filling capsules with any solid or liquid oral formulation. The machine combines a compact footprint with advanced technologies and will be showcased alongside its standard monoblock version. Also featured on the stand will be a double-layer rotary tablet press, a compact single-layer tablet press, and a suppository and pessary production line incorporating integrated filling, cooling, sealing, cutting and coding systems. Finally, visitors will be able to see a bench-top blister machine with three independent stations that can thermoform, seal, code and cut in a single seamless cycle. Booth 9A2

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Milan 2026 | Special

Technology and research for pharmaceutical single-dose packaging At CPHI Milan 2026, Universal Pack will showcase its approach to single-dose packaging: a combination of scientific research, engineering expertise and solutions developed around each customer’s specific production requirements. Specialising in sachet and stickpack packaging technologies, Universal Pack develops solutions for powders, liquids, tablets and capsules, with an increasing focus on high-output applications. One of the company’s key areas of development is high-speed packaging, with multi-lane machines designed to combine productivity, accuracy and process continuity, including within complete lines integrated with secondary packaging systems. A particularly strategic area is the packaging of tablets, including effervescent and coated tablets, as well as softgel capsules. Universal Pack develops systems capable of handling different product types on the same packaging machine while maintaining high levels of performance and flexibility. This expertise

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responds to the pharmaceutical industry’s growing interest in packing tablets and capsules in single-dose formats such as sachets and stick packs, either as an alternative or a complement to more traditional packaging solutions. Another technology of particular interest is dual filling, which enables two different products to be dosed separately into the same pack. In specific applications, the active pharmaceutical ingredient and excipient can therefore be handled without a prior premixing stage, opening up new possibilities in terms of process configuration and dosing control. High performance, however, is not simply a matter of speed. A pharmaceutical packaging project must take into account product behaviour, packaging material, dosing accuracy, sealing performance and the line’s operating conditions. This is why Universal Pack has established an in-house R&D laboratory, where products and laminates are tested before the final technological solution is defined. The results support the design of the dosing system, sealing units, extraction systems and other components that directly affect machine performance. The same approach is becoming increasingly important when working with new packaging materials. The introduction of recyclable and mono-material structures can affect parameters such as thermal behaviour, sealability and film handling. Universal Pack has been carrying out tests and developing dedicated machine configurations for several years, adapting the packaging process to the characteristics of new

laminates while maintaining high production performance. In the pharmaceutical industry, technology also means validation and process control. Universal Pack manages machine-related documentation and functional analyses in-house, supporting each project with dedicated documents and procedures covering the different qualification stages. Shaping the future of single-dose packaging Universal Pack’s presence at CPHI Milan 2026 will therefore provide an opportunity to engage with pharmaceutical manufacturers and CDMOs on the key trends shaping the future of single-dose packaging: higher productivity, greater flexibility, new dosage forms, dosing accuracy, new materials, digitalisation and consistent performance throughout the entire lifecycle of the equipment. For Universal Pack, innovation starts with the real application: understanding the product and the pack, defining the process and turning the data collected into a technological solution designed around the customer’s production needs. Booth 9J44

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Milan 2026 | Special

Expertise in the development of APIs ChemCon will present its expertise in the development and manufacture of high-purity active pharmaceutical ingredients (APIs) and fine chemicals. With more than 25 years of experience in custom synthesis and contract manufacturing, the German CDMO supports pharmaceutical projects throughout their development, from synthesis and process development to scale-up, GMP production and analytical services. Its activities cover organic and inorganic chemistry as well as polymer chemistry, with particular expertise in niche and demanding substances. A key feature of ChemCon’s business model is its focus on small to medium production volumes. At its facility in Freiburg, Germany, the company manufactures GMP-com-

pliant pharmaceutical ingredients for annual requirements ranging from less than 100 grams to several hundred kilograms. This approach is designed to support projects from clinical development and registration through to commercial supply, including applications in areas such as oncology, orphan diseases, critical care, dermatology and ophthalmology. ChemCon also has specific capabilities in the handling of highly potent and cytotoxic APIs. Its portfolio extends beyond conventional drug substances to include GMP-compliant excipients, delivery agents, diagnostics, reference standards and specialised inorganic compounds. Dedicated and multipurpose equipment, together with cleanroom facilities, allows the company to adapt its production environment

to individual project requirements. Analytical and regulatory support forms another integral part of the company’s offering. In-house services include chemical characterisation, impurity determination, analytical method development and validation, quality control, release analysis and stability studies. ChemCon also provides regulatory support for GMP projects, including process validation and assistance with international dossier submissions. At CPHI Milan, ChemCon will therefore highlight its integrated CDMO approach, combining chemical expertise, process engineering, GMP manufacturing and analytical capabilities. Booth 8F38

For 70 years alongside the manufacturing processes Seventy years is an important milestone for any company. For Novinox, however, it represents above all the ability to do something that has remained unchanged over time: to evolve alongside the industries it serves. Founded in 1956, Novinox is now a third-generation family-owned company. This continuity has enabled the company to preserve the values on which it was built—reliability, technical expertise and customer focus—while transforming them into a culture of innovation capable of meeting the challenges of an ever-changing market. Over the past seventy years, the pharmaceutical, nutraceutical, food and chemical industries have undergone profound transformation. Manufacturing processes have become increasingly complex, quality standards have risen significantly, and the demand for highly customized processing systems has become the norm. At the same time, digitalization, sustainability and international regulations have re-

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defined the way process equipment is designed and manufactured. For Novinox, innovation has never simply meant introducing new technologies. It means understanding each customer’s production needs and transforming them

into practical, reliable solutions. Today, Novinox designs and manufactures process equipment and complete systems for handling liquids, powders, creams and gels, supporting customers throughout every stage of a project—from process definition to the final installation of the plant. This tailor-made approach has always been one of the company’s defining strengths. Looking ahead, Novinox continues to invest in expertise, technology and research, convinced that true innovation is born where experience meets the ability to imagine what does not yet exist. In 2026, as the company celebrates its 70th anniversary, CPHI Milan provides an ideal opportunity to meet customers and partners from around the world and to share the philosophy that has guided Novinox since its foundation: developing solutions that go beyond meeting a requirement—they bring ideas to life. Booth 9K4

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Technologies

Customized solutions based on a proven machine platform The use of Stäubli robots and Schunk grippers in a pharmaceutical customer project demonstrates HERMA’s manufacturer-independent integration expertise.

With a configuration of the 211R HC robotic labeling cell tailored for a pharmaceutical customer project, HERMA demonstrates how demanding labeling processes for autoinjectors can be flexibly automated. The foundation is the proven, standardized 211R HC labeling cell, which HERMA has specifically adapted to the application’s requirements. At the heart of the system is a process architecture tailored to the customer’s process, featuring a Stäubli TS2-

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100 SCARA robot, a buffer station, and a separate transport and rotation unit. The interaction of these components enables a stable, reproducible process while ensuring gentle handling, even with complex product geometries. The SCARA robot uses a Schunk gripper to remove the unlabeled products from the trays and places them in a buffer station. There, a transport and rotation unit—also equipped with Schunk gripping technology—takes over. It guides the product to the applicator, a HERMA 500, and precisely rotates it as required during the labeling process. At the same time, the robot returns a labeled product to the tray and immediately retrieves the next one. Through this parallel operation, the system achieves a throughput of up to 15 products per minute. Seamless camera-based monitoring At the same time, the separate transport and rotation unit ensures precise alignment of the products. This is particularly advantageous for complex geometries and sensitive autoinjectors, which must be handled reliably and gently throughout the entire process. In combination with the custom-integrated transport and rotation unit, the HERMA 500 applicator can also fully realize its precision potential. An integrated camera system monitors the process and provides additional safeguards for the individual process steps. This allows for the monitoring of the labeling process as well as the position and align-

ment of the products and the applied markings. Non-conforming products can be reliably detected and diverted from the rest of the process. The proven, intuitive drawer system also ensures maximum process reliability: Products are fed into the enclosed labeling cell via this system and removed again after processing, without the need to open the safety doors during operation. Standard configuration flexibly adapted to individual requirements This configuration, implemented for a customer project, underscores the high adaptability of the standardized 211R HC robotic labeling cell. Depending on the product, process, and customer requirements, HERMA integrates suitable automation and robotics components from renowned partners into an optimally coordinated overall concept. The current version utilizes a Stäubli TS2-100 and two grippers from Schunk. In other customer projects, for example, components from Fanuc or Weiss Robotics have already been integrated within the same platform. The current application thus exemplifies how HERMA relies on a proven standard concept and, together with selected partners, adapts it specifically to individual tasks. “We use robotics specifically where it makes processes safer, more efficient, and simpler for our customers,” says Jana Paul, Team Leader of Product Management at HERMA. “The precise interaction of all components—from picking and placing to product guiding, labeling, and checking—is crucial. That’s why we configure our standardized solution to suit each specific application and integrate the components that offer the greatest added value for the customer.”

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AD

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Digital transformation

What Annex 22 spells for AI in GMP manufacturing Europe’s first dedicated framework for artificial intelligence in GMP manufacturing is close to finalisation and it is more demanding and more consequential than many manufacturers may currently appreciate. by Adam Cross*

*Industry Director - Pharmaceuticals & Life Sciences in Octave

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harmaceutical manufacturers in Europe have great ambitions for AI: in a survey we ran with Forrester last year, more than 6 in 10 reported that they would be investing in AI for predictive maintenance (65%), AI-based natural language interfaces

(61%) or machine learning (61%) in the next twelve months. However, AI use in GMP environments has been somewhat of a regulatory grey zone, governed loosely by the general provisions of GMP Annex 11 on computerised systems, which was last substantively updated in 2011 and was never written with machine learning in mind.

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Digital transformation That grey zone is closing with EudraLex Volume 4 - Annex 22, a draft of the first dedicated regulatory framework for artificial intelligence in GMP environments. Final publication is expected in second half of 2026, with enforcement phased in from 2027 to 2028. As drafted, Annex 22 covers static models: models whose parameters are fixed and which do not adapt during use. Dynamic models that continue to learn and adapt during live use are explicitly excluded from critical GMP applications and - in a provision that will disappoint enthusiasts of the current AI moment - so are generative AI and large language models. However, this doesn’t mean that they cannot be used in non-critical contexts, with a human-in-the-loop with adequate qualifications must remain responsible for any output. Five commandments Obligations are substantive and span the full lifecycle of an AI model from initial design through to ongoing operation, and sit on top of existing Annex 11 obligations, not instead of them. Here are the five requirements with the most consequential impact on manufacturing operations. Define the intended use first - Before any acceptance testing begins, the intended use must be documented precisely along with the full range of inputs the model will encounter: common cases, edge cases, rare variations, potential errors and sources of bias. A process subject matter expert must sign this off. If the model’s purpose and failure modes cannot be articulated, testing cannot begin. Performance must not go backwards -Test metrics must be defined and approved before testing starts, not after the results are in. More pointedly, the

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Solutions for managing critical industrial assets Octave provides software solutions that help enterprises design, build, operate, and protect critical industrial and infrastructure assets. Octave supports decision-making throughout the entire asset lifecycle, in environments where performance, safety, and reliability are paramount and failure is not an option. Octave bridges engineering, operational, and safety workflows, enabling customers to transform complex operational data into decisions that improve performance, resilience, and incident response in real-world environments.

model must perform at least as well as the process it replaces. For sites where the old process was never formally benchmarked, that work needs to happen first. Keep test data clean and separate Test data must be strictly separated from training and validation data, enforced by both technical and procedural controls. Staff who had access to test data cannot be involved in training the same model, unless paired with a colleague who did not. This four-eyes principle is borrowed from financial controls.

the approval process. The point is not just that the model gets the right answer but that it is doing so for the right reasons. Change control applies to everything the model touches - Once deployed, any change to the model, the system

The model must show its working -The system must record which features drove each classification or decision, using tools such as SHAP values, LIME or heat maps, and a review of those features must form part of

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Digital transformation

it runs on or the physical objects it uses as input must be assessed for whether revalidation is needed. Confidence scores must be logged for every prediction, and when confidence drops below an appropriate threshold the model should return ‘undecided’ rather than force a classification it is not sure about. How will this change things in practice? The honest answer, for most European pharma manufacturers, is: considerably. Under the existing framework, an AI model in a manufacturing context was typically governed as validated software under Annex 11. That meant documenting functionality, testing expected outputs and maintaining change control. What Annex 11 never required was any systematic treatment of training data, test data independence, model explainability, confidence scoring or input drift monitoring. Expected implications on predictive maintenance AI-assisted predictive maintenance is already widely deployed: models trained on vibration data, tempera-

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ture profiles and process historian records identify degradation patterns and recommend intervention windows. Under Annex 22, any such model that affects product quality or data integrity is in scope, requiring a documented input sample space, predefined acceptance criteria, independent test data and ongoing performance monitoring. Equipment changes must be assessed against the model’s intended use. Replacing a centrifuge bearing can alter the input sample space and now requires formal evaluation. This creates a direct and previously non-existent link between asset lifecycle management and AI governance. Information management: no dataset left unturned The governance requirements of Annex 22 build on revised GMP Chapter 4, which mandates risk-based data governance, audit trails and lifecycle traceability for electronic records. For AI systems, datasets, logs and model configuration files become GMP documentation. Most AI models in manufacturing have been developed by data science or automation teams, with data sitting in operational technology systems, engineering databases and vendor-controlled cloud platforms. Bringing all of that under a coherent GMP document management framework requires structural integration between data science operations and the quality management system that most sites do not yet have. Legacy software and practices: reassess and remediate or retire Annex 11 already requires that computerised systems be evaluated against current requirements when significant changes occur. The introduction of Annex 22 is itself such a change for any in-scope AI system, so

grandfathering existing deployments is not an option. The practical consequence is a portfolio review: identify all AI and ML components, assess which fall within Annex 22 scope, document the gaps and remediate or retire. For large sites with multiple vendor systems containing embedded ML, this is a substantial effort. It is also worth noting that Annex 22 places full responsibility for validation evidence on the regulated company, regardless of whether the model was built in-house or supplied externally. There is no such thing as a vendor black box. Clarity, and some recognition for doing it right It would be easy to read Annex 22 as a burden, and in the short term, for unprepared sites, it is. But the cleaner assessment is that it resolves a genuine regulatory ambiguity that has been causing its own costs. For years, quality assurance teams have struggled to sign off on AI deployments because there was no clear regulatory template for what adequate validation looked like. Annex 22 provides an authoritative answer. Inspectors will have a shared reference point and companies will be able to design validation programmes with confidence that meeting the annex’s requirements will satisfy regulators. The framework also creates a level playing field on quality. Sites that have invested in rigorous AI governance, with proper data management, explainability tooling, change control for models, will no longer be disadvantaged against competitors that deployed faster but with less discipline. The algorithm and the autoclave have been working alongside each other for years: Annex 22 finally sets the terms of that relationship.

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PUMPS AND FILTERS

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Chemical industry

CBRN decontamination kits: past, present and future of a increasingly strategic asset The evolution of decontamination systems developed by the Stabilimento Chimico Farmaceutico Militare of Florence, from traditional NBC kits to modern multi-platform BX24 and RSDL solutions. Future perspectives at the intersection of recurring warfare threats, climate change and emerging technological vectors, from metal-organic framework catalysts to AI-integrated wearable biosensors. by Arcangelo Moro*. Lorenzo Margheriti**, Gaetano Capasso***

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*Commander of the SCFM **Technical Director and Qualified Person, SCFM *** Head of Manufacturing Department, SCFM

BRN threats – chemical, biological, radiological and nuclear – have returned to the top of the European strategic agenda. The war in Ukraine has reintroduced the deliberate use of toxic agents on the battlefield (in November 2024, the OPCW formally confirmed the presence of 2-chlorobenzylidenemalononitrile – CS – in an incident along the confrontation lines in the Dnipropetrovsk region); the poisonings of Salisbury in 2018 and of dissident Alexei Navalny in 2020 brought Novichok agents back onto the international scene, a class of organophosphorus compounds developed during the Cold War; the 1995 Tokyo subway attack, in which the Aum Shinrikyo cult released sarin gas, remains the historical benchmark for chemical threats outside the theatre of operations. In parallel, the concept of

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Fig.1 - The NBC decontamination kit issued to the Italian Army until 2016, the reference asset of the first generation of individual CBRN systems produced by the Stabilimento Chimico Farmaceutico Militare of Florence

hybrid CBRN threats – in which the use of toxic agents combines with kinetic, cyber and disinformation actions – has consolidated, follow-

ing a trajectory that NATO formally recognised in the 2022 revision of its CBRN Defence Policy. In this context, the availability of

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Chemical industry portable, effective and operationally simple decontamination kits represents a strategic objective for Armed Forces, civil protection organisations and first responders operating in industrial environments. Italy, through the Military Chemical Pharmaceutical Plant (SCFM) of Florence, has historically contributed to this field with the design and production of CBRN decontamination systems capable of ensuring immediate response capability in contaminated environments. In the following pages we reconstruct the technical evolution of these systems and outline the future perspectives across two scenarios that are progressively overlapping: the return of conventional and hybrid warfare risk, and the new geography of CBRN risks driven by climate change. The chemical threat: molecular mechanisms and operational relevance Nerve agents – the most lethal class of chemical warfare agents – are organophosphorus compounds that exert their toxicity through the irreversible inhibition of acetylcholinesterase, the enzyme responsible for the degradation of acetylcholine. The accumulation of this neurotransmitter at synaptic junctions produces uncontrolled stimulation of the nervous system, with clinical manifestations that rapidly progress from miosis, rhinorrhea and lacrimation to muscle fasciculations, convulsions, respiratory failure and death. The first modern nerve agents – Tabun (GA), Sarin (GB), Soman (GD), Cyclosarin (GF) – were synthesised in Germany during the 1930s in the course of research on organophosphate insecticides. VX was developed by the United Kingdom in the 1950s and

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Tab. 1 - Physico-chemical characteristics of Type A absorbent powder Parameter

Reference value

Granulometry (45 μm residue) Swelling capacity Humidity Cation exchange capacity Smectite content SiO2 / Al2O3 / Fe2O3 CaO / MgO / K2O / Na2O

Max 3% Min 30 ml / 2 g 12 – 14% 90 – 110 meq/100 g Min 80% 49.18% / 16.80% / 15.72% 2.48% / 2.45% / 1.56% / 2.32%

analogous compounds were independently developed in the Soviet Union, with the subsequent evolution of the Novichok family. Immediate post-exposure decontamination is essential to limit dermal absorption and reduce clinical consequences. The available window is measured in minutes: studies conducted by the U.S. Army Medical Research Institute of Chemical Defense and by European reference laboratories indicate significant therapeutic windows if skin decontamination is initiated within 30 minutes of exposure to VX, with even more stringent times for G-series agents. Within this narrow temporal horizon, portable kits find their operational justification: self-protection or buddy-aid devices, designed to be used by the operator or by fellow soldiers in the very first moments after exposure, before qualified medical intervention becomes available. The first-generation NBC kit: architecture and active ingredients The NBC kit issued to the Italian Army until 2016 (Fig. 1) was conceived for immediate field use following exposure to chemical or radiological contamination. The system comprised two Type A sprinkler gloves, two Type B sprinkler gloves, two blocks of M72 mini-type detection papers, one SX34 equipment decontamination kit, a

camouflage carrying container and technical documentation on CDROM. The Type A glove was designed for the removal of persistent liquid toxic agents from skin, weapons, vehicles and equipment. The system employed an absorbent powder contained within a liquid-proof glove package, allowing operators to apply the product directly to contaminated surfaces. The decontamination mechanism was essentially physical: adsorption on mineral compounds analogous to Fuller’s earth materials, followed by mechanical removal via the integrated sponge-like surface. The physico-chemical characteristics of the Type A powder are summarised in Table 1. The Type B powder represented a significant technological improvement. A composite formulation based on modified bentonite clay containing Fe(III)-based catalysts and oxidising compounds – sodium perborate and sodium percarbonate – combined adsorption and oxidative degradation. The heterogeneous catalysts enabled in-situ generation of reactive oxygen species capable of degrading toxic compounds and, simultaneously, exerting biocidal activity. Unlike many earlier decontamination systems, the formulation did not contain chlorine-based oxidants – a choice that reduces environmental

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Chemical industry mission-critical electronics must remain operational even after exposure to contaminants.

Fig. 2 - New generation CBRN decontamination kit developed by SCFM (2026): BX24 multi-platform decontaminant in dispenser bottle, two M72 detection papers, camouflage glove/pouch, USB flash drive with technical documentation and operational manual

toxicity and operator risk. The decontamination process was structured in adsorption of the contaminant, oxidative degradation, water activation and mechanical removal: a multifunctional system model that would anticipate the direction taken in the following decade. The M72 detection papers are chemically treated indicator papers used for the rapid identification of liquid chemical warfare agents through colour change. The adhesive-backed papers can be applied directly to helmets, protective clothing, visors, vehicles and operational equipment. The colour code is standardised: vesicant agents (mustard) produce a red-topurple shift; G-series nerve agents produce a yellow-to-orange shift; V-series nerve agents produce a blue-green-to-black shift. The system enables immediate operational assessment of contamination status and supports rapid tactical decision-making.

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The SX34 kit, finally, was specifically developed for the decontamination of sensitive electronic and optical systems that could be damaged by conventional liquid decontamination products. Comprising a soft applicator, a brush, a cleaning cloth, protective gloves and controlled-aerosol cleaning agents, the system employed a dry, non-corrosive decontamination process capable of preserving the functional integrity of radios, optics, connectors, electronic systems and vehicle interiors. This capability has become increasingly critical in modern military operations, where

The new generation: 2026 CBRN kit and the BX24 multi-platform decontaminant The latest-generation CBRN decontamination kit developed by the Military Chemical Pharmaceutical Plant of Florence (Fig. 2) includes one BX24 decontamination dispenser bottle, two M72 detection papers, one camouflage glove/pouch, a USB flash drive with technical documentation and the operational manual. The reduction to a single decontamination agent – BX24 in place of the two Type A and Type B powders – is in itself a significant logistical simplification, but the real technical advance lies in the multifunctional nature of the active principle. BX24 is a broad-spectrum CBRN decontaminant effective against a wide range of chemical contaminants, biological agents, radiological particles and hazardous industrial materials. It can be deployed as a dry powder or diluted in water as a decontamination solution. In dry form it is intended for immediate personal decontamination, adsorption of hazardous substances and decontamination of personal protective equipment and gear; in diluted form it is indicated for postevent decontamination and for preventive protective coating applications. The chemical composition of

Tab. 2 - Chemical composition of the BX24 broad-spectrum CBRN decontaminant Component

Percentage

Troclosene sodium dihydrate (sodium dichloroisocyanurate) Sodium carbonate Sulfuric acid mono-C12-14 alkyl esters, sodium salts (surfactant) Co-formulants and stabilisers

40% 30% 5% q.s. to 100%

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Chemical industry BX24 is summarised in Table 2. The active principle, troclosene sodium dihydrate, is a slow-release source of active chlorine (ClO−) capable of rapidly oxidising a broad spectrum of chemical compounds and exerting broad-range biocidal activity; sodium carbonate stabilises pH in an alkaline environment, a condition favourable to the hydrolysis of organophosphorus nerve agents; the surfactant improves wettability of contaminated surfaces and facilitates physical removal of the residue. The multifunctional nature of BX24 simplifies logistics, reduces training complexity and increases operational flexibility across the various deployment scenarios – military, civil protection and industrial. Active neutralisation on the skin: RSDL integration Among the most significant innovations in the evolution of CBRN kits is the proposed integration of Reactive Skin Decontamination Lotion (RSDL) into the Italian system. RSDL is a product specifically developed for the emergency neutralisation of chemical warfare agents on intact skin, approved by the U.S. Food and Drug Administration in 2003. The active ingredients are potassium 2,3-butanedione monoximate (KBDO) and 2,3-butanedione monoxime (DAM): a chemical system that neutralises through accelerated hydrolysis V-series nerve agents (VX, VR), G-series agents (Tabun, Sarin, Soman) and sulfur mustard, with recent evidence of efficacy also against T-2 toxin and – a datum of particular relevance in light of the Salisbury and Navalny incidents – against Novichok-class agents. The product is packaged in portable sachets containing a sponge

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tion equipment and alarm systems, protective equipment, decontamination equipment and decontaminants, medical antidotes and treatments, and advice on any of these protective measures”. (Chemical Weapons Convention - Article X, §2 (excerpt).

impregnated with the active solution (Fig. 3): a 21 ml sachet is sufficient for the decontamination of face, neck and hands. The declared shelf life is five years. In-vivo experimental studies on animal models – summarised in systematic reviews published during the 20112024 decade – have demonstrated the superiority of RSDL over traditional methods (soap and water, 0.5% diluted hypochlorite, Fuller’s earth, M291 kit) against exposure to GD, VX and VR. A study published in Chemico-Biological Interactions in 2024 demonstrated the efficacy of RSDL in the skin decontamination following exposure to a Novichok-class nerve agent, a finding that reinforces the operational rationale for the integration of the product in the latest-generation European kits. The Organisation for the Prohibition of Chemical Weapons (OPCW) provides the regulatory framework that orients the selection of countermeasures: “Each State Party shall […] provide assistance and protection against the use or threat of use of chemical weapons […] which shall include, but not be limited to, detec-

One system, many threats: comparing the two generations The transition from the traditional NBC kit to the new CBRN system reflects the evolution of operational requirements and of available technological capabilities. The older kit relied essentially on absorbent powders and mechanical removal of the contaminant, integrated with detection papers and an electronics-dedicated system. The new system introduces a multifunctional broad-spectrum decontaminant, simplifies procurement logistics, integrates active skin detoxification capability through RSDL and overall improves personal protection. The replacement of the powders with BX24 reduces operational complexity and improves system versatility across military and civilian scenarios. The integration of RSDL represents a paradigm shift: from passive adsorption to active chemical neutralisation of the contaminant directly on the skin surface. The retention of M72 detection papers within the new system confirms the enduring strategic value of rapid field detection. Overall, the evolution describes a transition trajectory from predominantly mechanical decontamination systems toward integrated multifunctional detoxification technologies that combine adsorption, oxidative degradation and active chemical neutralisation within a single system architecture.

Fig.3 Reactive Skin Decontamination Lotion sachet (training model). The product is packaged in portable sachets containing a sponge impregnated with the active solution; a 21 ml sachet is sufficient for decontamination of face, neck and hands

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Chemical industry

Key technical glossary CBRN - Chemical, Biological, Radiological, Nuclear: Category of non-conventional threats encompassing chemical, biological, radiological materials and nuclear agents. BX24: Broad-spectrum CBRN decontaminant developed by SCFM, based on troclosene sodium dihydrate and sodium carbonate, deployable as dry powder or in aqueous solution. RSDL - Reactive Skin Decontamination Lotion: FDA-approved (2003) skin decontamination lotion; active ingredients KBDO and DAM; effective on intact skin against G/V nerve agents, sulfur mustard and Novichok. M72: Chemical detection papers for liquid CWA identification via chromatic shift; V-series → blue-green/black; G-series → yellow/orange; vesicants → red/purple. MOF - Metal-Organic Framework: Porous crystalline materials able to catalyse the hydrolysis of organophosphorus compounds; the Zr6 formulations (UiO-66, NU-1000, MOF-808) are the most promising. HERA: Health Emergency Preparedness and Response Authority. European authority for health preparedness, €6 bn budget 2022-2027, rescEU CBRN stockpile €1.2 bn. OPCW - Organisation for the Prohibition of Chemical Weapons. International organisation headquartered in The Hague, tasked with the implementation of the 1997 Chemical Weapons Convention. Future perspectives – Warfare scenario: hybrid warfare, drones and synthetic catalysts The lessons of the Ukrainian conflict are reshaping the physiognomy of the CBRN threat. Since 2022, Ukraine has reported more than 4,600 chemical incidents on the battlefield, most linked to the use of riot control agents (CS) and chloropicrin – the latter a First World War compound classified under Schedule 3 of the Chemical Weapons Convention – deployed to dislodge Ukrainian forces from fortified positions. The release vector has changed: no longer conventional munitions, but hybrid systems such as modified K-51 grenades, improvised devices and grenades dropped by short-range FPV drones. This is the paradigm of hybrid CBRN warfare, formally recog-

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nised in the 2024 JCBRN Defence COE report Hybrid Threats in the CBRN Environment: a threat that does not readily lend itself to unambiguous attribution and that multiplies the number of potential release points. In this scenario, three research lines are defining the next generation of decontamination systems: 1) Zirconium-based metal-organic framework (MOF) catalysts. Systems such as UiO-66, NU-1000 and MOF-808 are porous crystalline materials capable of catalytically hydrolysing the P-F and P-O bonds of organophosphorus nerve agents under mild ambient conditions. The most advanced formulations – MOF808/SiO2 aerogels and MOF-polymer composite membranes — have demonstrated half-lives of just 5-9 minutes for dimethyl-4-

nitrophenylphosphate (DMNP), an established nerve agent simulant. Integrated into the fabrics of personal protective equipment, MOFs would transform PPE from a passive barrier into an actively detoxifying surface, capable of neutralising the contaminant at the very moment of its deposition. 2) AI-integrated wearable biosensors. Miniaturised chemical and biological sensors connected to real-time analytics platforms – flagged as a research priority by NATO STO in the 2022 Technical Report Artificial Intelligence for CBRN Defence Applications and by the European Defence Agency – will enable continuous monitoring of operator exposure, physiological parameters and ambient contamination levels, generating early-warning alerts and supporting real-time tactical decision-making. The convergence of these technologies with theatre telemedicine will, in perspective, enable automated triage and remote activation of therapeutic protocols. 3) Threat-agnostic approaches and modular platforms. The European priority, defined by HERA in the EU4Health 2025 calls dedicated to CBRN medical countermeasures, is shifting from agent-specific products to modular platforms capable of responding to a-priori-unknown threats. mRNA vaccines, monoclonal antibodies with flexible production and broad-spectrum antidotes outline a model of agile stockpiling, in which manufacturing capacity partially replaces warehousing capacity. Future perspectives - Climate scenario: permafrost, industrial hazards, logistical resilience The second axis of transformation

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Chemical industry of the CBRN threat is climatic. An October 2025 JCBRN Defence COE document dedicated to the Arctic context explicitly acknowledges that thawing permafrost not only destabilises military and civilian infrastructure but also releases hazardous pathogens, industrial pollutants and radioactive waste buried for decades. A study published in Nature Communications in March 2023 identified approximately 4,500 industrial sites active in Arctic permafrost regions and estimates the existence of 13,000-20,000 correlated contaminated sites; of these, about 1,100 industrial sites and 3,500-5,200 contaminated sites will begin thawing before the end of the century. The geography of CBRN risk is literally extending northward under the driver of climate warming, which in Arctic regions is proceeding at a rate between two and four times faster than the global average. Biological risk adds to this picture. A review published in Nature Climate Change in 2021 documented the potential reactivation of microorganisms (bacteria, fungi, viruses) sequestered in permafrost for tens or hundreds of thousands of years. In 2023, researchers at the Aix-Marseille Université demonstrated the reactivation of giant viruses (Pandoravirus and Pithovirus) recovered from Siberian permafrost samples 30,000-48,000 years old: an experiment conducted on strains not pathogenic to humans, but whose replicability demonstrates the vitality of the biological principle. The scientific community further recognises the increased frequency of extreme weather events – floods, hurricanes, heat waves – as a fac-

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tor destabilising chemical and nuclear industrial sites: a structural risk that the European Commission, in its 2025 HERA Report on cross-border health threats, explicitly included among emerging threats. The implications for decontamination kits are twofold. On one hand, the spectrum of action must be broadened: a decontaminant designed against organophosphorus nerve agents is not necessarily effective against heavy metals released from a collapsed mining site or against ancestral pathogens re-emerging from a retreating

As the only State-owned pharmaceutical manufacturing facility in Italy, operating under the direct authority of the Defence Industrial Agency of the Ministry of Defence, SCFM oversees an integrated national production capability: from the formulation of decontaminants to the manufacture of antidotes, orphan/shortage medicines and medical-surgical countermeasures of strategic relevance. It is a model of applied pharmaceutical sovereignty, consistent with the European logic of strategic autonomy in the health sec-

The thawing permafrost not only destabilises military and civilian infrastructure but also releases hazardous pathogens, industrial pollutants and radioactive waste buried for decades glacier. On the other hand, logistical resilience must be rethought: shortened supply chains, distributed production, capacity for rapid response in multi-hazard crisis scenarios. This is the direction being taken by the European strategy, which has assigned HERA a €6 billion budget for the 2022-2027 period and has established, under the rescEU mechanism, a stockpile of CBRN medical countermeasures worth €1.2 billion, including antidotes, antibiotics, vaccines and dedicated equipment. The role of SCFM: pharmaceutical sovereignty and continuity of supply Within this complex framework, the role of the Military Chemical Pharmaceutical Plant assumes a strategic dimension that transcends the production of individual kits.

tor but anchored to a specific institutional mission: ensuring that Italy has, in peacetime as in crisis, a public manufacturing capability able to meet the needs of the Armed Forces, of Civil Protection and of the National Health Service. Participation in European preparedness programmes, integration with the HERA framework and collaboration with NATO Centres of Excellence for CBRN defence define a network of belonging that multiplies the value of national capability. The development pathway of the CBRN kits – from the traditional NBC system to BX24, from the integration of RSDL to the perspectives of MOF catalysts and wearable sensors – is the operational manifestation of this mission: an ongoing development of technical solutions capable of adapting to a threat that changes form but not nature.

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Chemical industry Conclusions The evolution of the CBRN kits developed by the Military Chemical Pharmaceutical Plant of Florence describes a coherent trajectory: from systems based on absorbent powders and mechanical removal to modern multi-platform decontaminants, integrated with technologies of active neutralisation on the skin. The transition is not merely technical. It is the reflection of a threat that has transformed itself – multiplied in vectors, hybridised in release modalities, expanded by climatic factors – and that requires an equally systemic response, capable of com-

bining chemical efficacy, operational simplicity and logistical resilience. Future perspectives – MOF catalysts integrated into PPE fabrics, wearable biosensors with AI-supported real-time analytics, threat-agnostic platforms for medical countermeasures – point to a clear direction: active, distributed and adaptive protection systems, capable of operating in multi-hazard environments and of responding to threats that may still be unknown at the time of design. The challenge is no longer merely to neutralise the known agent, but to prepare the architecture capable of neutralis-

ing the future agent. In this scenario, the Stabilimento Chimico Farmaceutico Militare confirms its role as a strategic industrial actor of the Italian State in the domain of CBRN defence and health preparedness. The public production capability – integrated within the European HERA framework and the NATO Centres of Excellence network – is today an essential component of national health sovereignty. A sovereignty which the contemporary geopolitical context and the ongoing climate crisis render progressively less optional and increasingly structural.

References and institutional sources Organisation for the Prohibition of Chemical Weapons (OPCW) - Report of the OPCW Technical Assistance Visit TAV/04/24 to Ukraine (November 2024). OPCW - Chemical Weapons Convention (1997), Article X “Assistance and Protection Against Chemical Weapons”. NATO - Comprehensive, Strategic-Level Policy for Preventing the Proliferation of WMD and Defending against CBRN Threats (2022 revision). JCBRN Defence Centre of Excellence - Hybrid Threats in the CBRN Environment (March 2025); CBRN Defence in the Arctic Context: Preparedness and Operational Challenges (October 2025). Schwartz M.D., Hurst C.G., Kirk M.A., Reedy S.J.D., Braue E.H. Jr. - Reactive Skin Decontamination Lotion (RSDL) for the Decontamination of Chemical Warfare Agent (CWA) Dermal Exposure. Current Pharmaceutical Biotechnology, 13(10):1971-1979, 2012. Thors L. et al. - Effective skin decontamination with RSDL ® following dermal exposure to a Novichok class nerve agent. Chemico-Biological Interactions, 2024. Hansen K.A., Doxzon B.F., Lumpkin H.L., Clarkson E., Braue E.H. Jr. - U.S. Army Evaluation of Decontamination Systems Challenged with Nerve Agents. USAMRICD, Aberdeen Proving Ground, MD. Sidell F.R., Takafuji E.T., Franz D.R. - Medical Aspects of Chemical and Biological Warfare. Office of the Surgeon General, U.S. Army, 1997.

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Langer M. et al. - Thawing permafrost poses environmental threat to thousands of sites with legacy industrial contamination. Nature Communications, 14:1721, 2023. Miner K.R. et al. - Emergent biogeochemical risks from Arctic permafrost degradation. Nature Climate Change, 11:809-819, 2021. Chen Z. et al. - Advances in Metal-Organic Frameworks for the Removal of Chemical Warfare Agents. MDPI Gels, 2023; MOF-808/SiO 2 aerogels for DMMP hydrolysis, halflife 5.29 min. NATO Science and Technology Organization (STO) - Artificial Intelligence for Chemical, Biological, Radiological and Nuclear Defence Applications. Technical Report, 2022. European Commission - HERA Work Plan 2024; EU4Health Programme 2025 Calls for Proposals on CBRN Medical Countermeasures (EU4H-2025-HERA-PJ-1); COM(2025) 147 final. European Defence Agency (EDA) - Emerging Technologies for CBRN Protection and Military Medical Support. Brussels, 2023. Council Regulation (EU) 2022/2372 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level. US Department of State - Determination on Russia’s use of chloropicrin as chemical weapon against Ukrainian forces in violation of the CWC (May 2024).

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In this issue we spoke about...

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YEARXVII SUPPLEMENT NO.4 2026

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