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Behind the Headlines Episode 28

Ask the Expert

How evolving regulatory expectations are reshaping pharma development and manufacturing.

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Dr. Christine Allen is co-founder and CEO of Intrepid Labs. Dr. Allen is an internationally recognized expert in drug formulation and development, with over 200 peer-reviewed publications. She is a Professor at the University of Toronto and a Fellow of both the American Institute for Medical and Biological Engineering and the Canadian Academy of Health Sciences. She has held numerous leadership roles across academia and industry, including President of the Controlled Release Society and Editor-in-Chief of the 

Dr. Andrew Lewis is Chief Scientific Officer of Quotient Sciences. As the leader of Quotient Sciences' scientific teams and drug development consultants, Dr. Lewis is responsible for driving efficiency and innovation within our scientific organization, both to better serve our customers and drive growth for the Company.

Andy has over 25 years of experience in the pharmaceutical and drug delivery industry and is a member of the Academy of Pharmaceutical Scientists of Great Britain. Additionally, Andy has served on the board of directors of the Controlled Release Society, most recently as secretary.

Prior to joining Quotient Sciences, Andy was Director of Novel Drug Delivery Technologies at Ipsen. He holds a Ph.D. in Tissue Engineering and a Bachelor of Pharmacy, both from the University of Nottingham.

The utilization of artificial intelligence (AI) in the pharmaceutical industry is developing quickly. In drug development, the use of AI in formulation is a shift from traditional trial-and-error methods to a more data-driven, accelerated approach. AI is being utilized to bridge the gap between drug discovery and clinical trials, optimizing how a molecule is turned into a viable drug product.

AI is helping to compress drug development timelines by enabling faster data analysis and predictive modeling. Researchers can now design new molecules in weeks rather than months.

 AI-driven workflows for target identification have yielded an average time savings of 28%.

 Pharma Fundamentals video series. Episodes in this educational series aim to provide knowledge in the basics needed for pharmaceutical development and manufacturing, such as chemistry and pharmacology, breaking things down to the basics to help those working in the industry to better perform their jobs. Be sure to check the episode webpage for more topic information and resources. We hope you enjoy the series

Dr. Christine Allen, Co-Founder and CEO, Intrepid Labs

Dr. Christine Allen is Co-Founder and CEO of Intrepid Labs. Dr. Allen is an internationally recognized expert in drug formulation and development, with over 200 peer-reviewed publications. She is a Professor at the University of Toronto and a Fellow of both the American Institute for Medical and Biological Engineering and the Canadian Academy of Health Sciences. She has held numerous leadership roles across academia and industry, including President of the Controlled Release Society and Editor-in-Chief of the 

Dr. Andrew Lewis, Chief Scientific Officer, Quotient Sciences

Articles

Artificial intelligence is rapidly reshaping pharmaceutical development by replacing iterative formulation experimentation with data-driven, predictive approaches. By better linking discovery outputs to clinically viable drug products, AI helps optimize the transition from molecule selection to manufacturable formulations. These capabilities enable faster analysis of complex datasets and more accurate modeling of performance and risk, compressing development timelines. Reported impacts include designing new molecular entities within weeks rather than months and average time savings of 28% in AI-enabled target-identification workflows.

Dr. Christine Allen, Co-Founder and CEO of Intrepid Labs, and Dr. Andrew Lewis, Chief Scientific Officer of Quotient Sciences, explain how AI can be used in drug development to shorten development timelines. 

Pharma Fundamentals: Utilizing Artificial Intelligence in Drug Development

FDA headquarters at White Oak Campus in Silver Spring, Maryland, USA - January 13, 2020. The United States Food and Drug Administration (FDA) is a federal agency. | © JHVEPhoto - stock.adobe.com (330225712)

On May 27, 2026, the FDA announced it has extended its target review date for AstraZeneca's new drug application for camizestrant, a next-generation oral selective estrogen receptor degrader, used in combination with a cyclin-dependent kinase 4/6 inhibitor for first-line treatment of hormone receptor-positive, HER2-negative advanced breast cancer.

 The extension applies specifically to patients whose tumors develop an emergent ESR1 mutation, a genetic change increasingly recognized as a key driver of resistance to standard endocrine therapies.

The delay follows an April 2026 advisory committee meeting in which the FDA's Oncologic Drugs Advisory Committee failed to reach a majority vote supporting the benefit of the proposed treatment strategy.

 That strategy involves monitoring patients for ESR1 mutations in circulating tumor DNA and switching their endocrine backbone therapy upon detection, before radiographic disease progression is evident.

In response to the committee's outcome, AstraZeneca submitted additional analyses to the FDA, including circulating tumor DNA clearance data linked to longer-term efficacy outcomes.

 That data are scheduled to be presented at the American Society of Clinical Oncology annual meeting on June 2, 2026. The FDA's decision to extend the review period reflects its intent to evaluate this supplementary information before reaching a final determination.

Why Does the Regulatory Pathway Here Matter?

One of the most notable aspects of the application is built around a biomarker-driven, adaptive treatment strategy, one where patient selection depends on real-time molecular monitoring rather than a fixed clinical profile at diagnosis.

 Designing and executing pivotal trials around such endpoints introduces complexity in endpoint selection, patient stratification, and data interpretation that regulatory agencies are still working to standardize.

The pivotal SERENA-6 phase 3 trial, which enrolled 315 patients across a globally distributed site network, used investigator-assessed progression-free survival as its primary endpoint.

 Secondary endpoints included overall survival and a second progression-free survival measure. The trial's core innovation, switching therapy based on a detected mutation before visible disease progression, is precisely what made the advisory committee deliberations challenging, as it requires regulators to weigh intermediate biomarker signals against longer-term clinical outcomes data that continues to mature.

The filing also highlights the operational demands of combination drug applications.

 Camizestrant was evaluated alongside three distinct CDK4/6 inhibitors: palbociclib, ribociclib, and abemaciclib. The supporting data package spans multiple combination regimens, each with its own safety and efficacy profile. Managing that breadth across a single regulatory submission is a non-trivial undertaking.

On the international regulatory front, the picture is more advanced.

 The European Medicines Agency's (EMA’s) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for this indication on May 22, 2026.

 Camizestrant has already received approval in the United Arab Emirates and Saudi Arabia for the same setting, with applications under review in Japan and other markets. The divergence between the European and US regulatory trajectories serves as a reminder that even well-constructed global dossiers can encounter different evidentiary thresholds across jurisdictions, a planning consideration for any development team pursuing simultaneous multinational submissions.

Is the FDA's Extended Review of Camizestrant Part of a Wider Regulatory Pattern?

The camizestrant timeline is not an isolated case.

 In April 2026, the FDA similarly extended its review period for Sanofi's biologics license application for Sarclisa (isatuximab-irfc) subcutaneous formulation, used in combination with standard-of-care regimens for multiple myeloma across all indications currently covered by the existing intravenous formulation.

As with camizestrant, European regulators moved ahead of their US counterparts.

 The CHMP adopted a positive opinion recommending approval of the subcutaneous formulation in late March 2026, with a final decision anticipated in the coming months. Taken together, both cases reinforce a pattern of regulatory agencies navigating increasingly complex applications, and extended review timelines are becoming a more routine feature of the approval landscape for advanced oncology submissions.

AstraZeneca plc. US FDA decision date on camizestrant extended. Press release. May 27, 2026. 

https://www.astrazeneca.com/media-centre/press-releases/2026/us-fda-decision-date-camizestrant-extended.html

Sanofi. Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US. Press release. April 22, 2026. 

https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-22-05-00-00-3278646

The FDA extended the PDUFA date for camizestrant plus a CDK4/6 inhibitor in first-line HR-positive/HER2-negative advanced breast cancer with emergent ESR1 mutations, following an advisory committee vote that did not endorse benefit. The approach relies on serial ctDNA surveillance and preemptive endocrine switching before radiographic progression, raising questions about evidentiary standards for biomarker-triggered adaptation. AstraZeneca submitted additional ctDNA clearance analyses tied to longer-term outcomes, with readouts scheduled at ASCO 2026. Parallel EU momentum underscores divergent regional thresholds.

FDA extends AstraZeneca’s camizestrant's review deadline to assess additional data after its advisory committee failed to reach a majority vote in April.

FDA Delays AstraZeneca's Breast Cancer Drug Review: What to Know

Brian Drapeau is founder, GxPFrame and a cell and gene therapy manufacturing and quality systems consultant.

Women, scientist and discussion with tablet by glass, reading and review with results at pharma company. People, mentor and feedback with notes, application and medical research for mpox vaccine | Image Credit: ©Malambo20/peopleimages.com -stock.adobe.com

The cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) market is projected to grow 10x from $6.41 billion to roughly $75 billion by 2034 (see 

 However, FDA Form 483 observation trends

 tell a different story than one would gather from investment headlines. Recurring observations include incomplete training documentation, absence of written training procedures, failure to qualify personnel for assigned tasks, and the absence of a structured program for ongoing competency (detailed in 

). This discrepancy stems from a workforce being asked to expand on deliverables while remaining undertrained, under retained, and inadequately transitioned into the very roles they are hired to fill and execute. What follows is a cost-based argument for why training infrastructure is the variable that will separate the organizations still standing in 2034 from the ones that did not make it.

Figure 1. CGT CDMO Market Projection, 2024-2034. The global CGT CDMO market is projected to grow from $6.41 billion in 2024 to $75.32 billion by 2034, representing a compound annual growth rate of 27.94%.

 Source: Towards Healthcare, citing Precedence Research (2025).

Table 1. Recurring Training-Related FDA 483 Observation Categories in Biopharmaceutical Manufacturing (FY 2024)

The financial influx surrounding the investment in CGT manufacturing right now is genuinely striking. Johnson and Johnson committed $1 billion to a new facility in Montgomery County, PA, in February 2026, projecting more than 500 hires and committing to a production-ready date of 2031.

 Towards Healthcare, citing Precedence Research data, puts the global CGT CDMO market at a compound annual growth rate of roughly 28%, projecting a near 12-fold expansion over the present decade.

However, what those figures fail to show is this harsh reality: between 2020 and 2024, 74% of Complete Response Letters issued to CGT developers by the FDA cited quality or manufacturing deficiencies as the primary cause.

 In the same period, approximately 40% of investigational new drug applications were either rejected or outright stopped before reaching clinical evaluation as a result of inadequate chemistry, manufacturing, and controls.

 These are not the numbers of an industry that has its execution problem solved, or even close to being so. In fact, they are the numbers of an industry that has accelerated past its own operational readiness. The question is, why and how? A quick analysis of the pattern in FDA 483 observations from the same period shows exactly where these breakdowns are taking place.

A review of FDA Form 483 observations issued to biopharmaceutical manufacturers during fiscal year 2024 identified several recurring categories, all related to training deficiency: incomplete training documentation, absence of written training procedures, failure to qualify personnel for their assigned tasks, and no structured training program to maintain ongoing competency (see 

 These observations were not limited to startups or first-time facilities being inspected. Established CGT manufacturers received them as well.

The reason this pattern repeats itself is worth examining carefully. Training gaps in good manufacturing practice (GMP) environments are rarely fixed by uploading additional content to a learning management system (LMS). The LMS takes on the role of becoming an electronic repository of written procedures, but a completion report is not the same as training infrastructure. It is just a document repository with associated quizzes that serve to demonstrate a required procedure has been read. However, knowledge of all material read during a session is rarely retained, and the practical application of said knowledge is an entirely separate skill that requires repetition, failure, and troubleshooting. So, when the inspectors come with their questions, they rarely ask whether the course was completed, as it is assumed it is. Rather, they ask if the person doing the work can demonstrate competency in each area, and those are two very different questions.

) 211.25, personnel engaged in manufacture, processing, packing, or holding of a drug product must possess the education, training, and experience required for their assigned functions.

 Training must be conducted by qualified individuals, must cover the specific tasks the employee performs, and must include current GMP requirements. In a CGT facility, those tasks routinely include lentiviral vector handling, autologous cell processing, chain-of-identity management, and closed-system bioreactor operation. Applying the 211.25 standard to those environments is not a matter of checking a training completion box. An inspector standing in front of an operator who cannot explain why chain-of-identity controls exist, or what the consequence of a deviation in that step is, has found a training deficiency regardless of what the LMS record claims.

What is the Burn Rate in High Turnover GMP Environments?

The workforce problem strengthening this compliance picture is well-documented. A 2025 survey by the International Society for Cell and Gene Therapy found manufacturing and process development as the largest gap in the entire CGT workforce, with shortages greatest in technical laboratory, manufacturing, and quality control (QC) roles.

 A 2024 BioPlan Associates survey, as reported by Locwin, found that vacancy rates in critical CDMO positions, specifically manufacturing science and technology (MSAT), quality assurance, and automation engineering, exceeded 15% at many sites. The result was seen in major delays during technology transfer timelines and a significant increase in deviation frequency.

The industry response has been unsurprising. To mitigate these serious concerns, increased money has been thrown at the problem: larger salaries, elevated offers, title inflation, aggressive counteroffers, and extreme poaching. Not to say this approach is not understandable, as it does address immediate hiring pressure, but it fails to address what happens 12 months after you have placed new talent in a broken system.

The Society for Human Resource Management reports that replacing an employee costs between 50% and 200% of their annual salary when both direct and indirect expenses are fully accounted for.

 Direct costs are familiar: recruiting fees, time-to-fill, onboarding administration, and formal training. The indirect costs are where GMP environments diverge sharply from general industry. An operator less than six months into their role represents a documentation exposure in every batch record they sign. A quality associate who has not yet internalized investigation methodology represents a deviation-handling vulnerability that can surface in the next FDA inspection. A trainer who was never formally qualified is generating training records that an investigator can challenge on their face. These are not theoretical risks. They are the conditions described repeatedly, in the existing 483 observations.

The math is simple. From personal experience, when the chimeric antigen receptor (CAR)-T therapy boom first began in Northern NJ around 2013-2014, starting with Celgene and Novartis, the average cost to train a new operator was roughly equal to 1/3 to 1/4 of their starting salary, culminating in a roughly $75,000-$85,000 investment per operator once materials and trainer time were accounted for. Using the SHRM midpoint estimate, total replacement cost, including training investment, recruitment, and productivity loss, falls in the range of $75,000 for a manufacturing-level role.

 At a facility of 100 employees running 40% annual turnover, that generates 40 replacement events per year at a cost of approximately $3 million. At 20% turnover, the same facility spends roughly $1.5 million. That $1.5 million annual gap is not the result of paying people more (see 

). It is the result of whether the organization gave employees a reason to stay.

Table 2. Annual Turnover Cost Comparison: 100-Person GMP Manufacturing Facility

What Will Separate the Operations That Survive?

There is a recognizable profile to the organizations most at risk in the current expansion cycle. They have invested heavily in equipment and facilities. They carry significant overhead from paying competitive salaries. Many have implemented an LMS and consider the training question largely resolved. Unfortunately, reading and understanding only go so far. What is missing, consistently, is a sufficient training architecture built to create repeatable outcomes with minimal variance regardless of the individual working through it. A structured system connects role-specific competency requirements to a progression pathway from hire to fully qualified and does so in a way that enables the operator to understand not just the how, but the why. Implement documented checkpoints along that pathway and a visible career development model that answers the question every new employee is asking: What will my future here look like?

The career development component is the one most frequently absent, yet it is the main driver of unnecessary turnover.

When a CGT manufacturing operator leaves six months after completing onboarding, the departure is rarely about salary alone. In most cases, no competitor offered them a dramatically better compensation package. They received a marginally higher offer accompanied by a title that suggested forward movement. The incumbent employer lost that person not because they were outbid, but because they never communicated a development trajectory. The competitor did not offer a better job. They offered a story about the future.

Building that story is not a significant capital investment. A tiered qualification program, a structured mentorship arrangement, and a documented promotion framework require organizational design time and a committed training budget. They are operational decisions, not capital expenditures. Organizations that have made them consistently report lower voluntary turnover, more predictable inspection performance, and a workforce that can respond to FDA questions with documented evidence rather than a completion certificate.

The distinction the FDA draws during an inspection is the same one that determines whether an organization can scale. A training program designed to generate records is a compliance theater. A training architecture designed to produce competent operators is the actual product.

Regional Investment and the Workforce Readiness Gap

The concentration of CGT manufacturing investment along the mid-Atlantic corridor right now is not subtle. J&J's $1 billion Montgomery County commitment requires 500 qualified employees, and they are not waiting until 2031 to start hiring. Validation work starts well before product runs, which means they are going to be qualifying operators in a facility with no production history, on a regulatory timeline that cannot slip, while every other CGT site in the Philadelphia corridor is fishing in the same talent pool simultaneously.

So where does that workforce come from? The honest answer is that nobody really knows yet, and that is the problem. The ISCT survey from 2025 flagged that the US Department of Education has acknowledged that biomanufacturing workforce development is lagging current market demand.

 Community college partnerships are valuable. Regional workforce initiatives are a start. But enrollment to GMP-qualified operator is a multi-year process, not a quarterly one. Any organization banking on hiring a ready-made workforce from the existing market is going to run headfirst into a 15% vacancy rate and realize the market was never going to supply what they needed.

The workforce must be built internally. That means onboarding programs designed to compress qualification time without creating the documentation gaps that show up in 483 observations. It means training systems where inspection-ready records come out the other end of normal operations, not out of a remediation sprint two weeks before an audit. And it means giving people a reason to still be there in year two.

The $75 billion projection is real. The pipeline behind it is real. Nobody is disputing that this market is going where analysts say it is going.

What is not modeled in any of those projections is what it costs to deliver on them with an undertrained, high-turnover workforce. A $60,000 salary and $60,000 in training costs represent $120,000 walking out the door every time someone leaves before they have returned that investment to the organization. Run that math at 40% annual turnover across a hundred-person facility, and there is a $3 million annual burn rate that does not show up on any capital expenditure line, does not depreciate on a schedule, and compounds every year the underlying problem is not fixed.

The CDMOs that are still standing at the end of this decade are not necessarily going to be the best funded or the most scientifically sophisticated. They are going to be the ones that figured out earlier than their competitors that they cannot inspect their way to a competent workforce and they cannot salary their way to a retained one. Infrastructure must be built that produces both, and it must be done before the FDA performs an inspection.

The floor is not the LMS completion report. It never was. It is whether the person on the manufacturing floor can tell an investigator what they are doing, why it matters, and what happens when it goes wrong. Everything else is compliance theater.

Cell and gene therapy CDMO market size, share, trends, growth rate to 2035. Towards Healthcare. Published November 1, 2025. Accessed March 2026. 

https://www.towardshealthcare.com/insights/cell-and-gene-therapy-cdmo-market-sizing

Top FDA 483 observations from 2024 and strategies to mitigate them in 2025. PRP Compliance Group. Published July 12, 2025. Accessed March 2026. 

https://www.prp-compliance.com/post/understanding-the-top-7-fda-483-observations-from-2024-and-strategies-to-mitigate-them-in-2025

J&J plans $1B investment in PA cell therapy manufacturing facility. BioSpace. Published February 19, 2026. Accessed March 2026. 

https://www.biospace.com/drug-delivery/j-j-plans-1b-investment-in-pa-cell-therapy-manufacturing-facility

Why gene and cell therapies are stalling at the FDA. Drug Discovery News. Published August 3, 2025. Accessed March 2026. 

https://www.drugdiscoverynews.com/why-gene-and-cell-therapies-are-stalling-at-the-fda-16527

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-B/section-211.25

International Society for Cell and Gene Therapy Laboratory Practices Committee. Shaping the future of cell and gene therapy workforce development: training of cell therapy processing personnel. 

. Published online April 10, 2025. Accessed March 2026. 

https://www.sciencedirect.com/science/article/abs/pii/S1465324925006802

Locwin B. Science, scale, and skills: what will define the CGT CDMO champions. BioProcess International / Workforce Genetics. Published April 30, 2025. Accessed March 2026. 

https://workforcegenetics.com/science-scale-cell-gene-therapy-cdmo-market/

Society for Human Resource Management. Turnover cost calculation spreadsheet and benchmarking data. Updated 2025. Accessed March 2026. 

https://www.shrm.org/topics-tools/tools/forms/turnover-cost-calculation-spreadsheet

CGT CDMOs are on a steep growth trajectory, yet FDA quality signals show persistent execution risk driven by workforce readiness. Form 483 trends repeatedly cite training-system failures—missing procedures, incomplete documentation, unqualified personnel, and absent competency maintenance—reflecting gaps between LMS “completion” and demonstrable GMP capability. High vacancy and turnover amplify deviations, tech-transfer delays, and inspection exposure, creating a material, recurring burn rate. Durable advantage will come from training architecture that ties role-specific competencies to qualification pathways, mentorship, and career progression to retain talent and sustain inspection-ready performance.

The cell and gene therapy manufacturing workforce is having to expand on deliverables while remaining under trained.

Training: The Real Constraint in CGT Manufacturing

Sandra Coufal, Toragen, discusses her team's research targeting precancerous cervical cells, backed by a Gates Foundation grant and world-class advisors.

Inside the Expert Network Guiding TGN-S15 to Market

Sandra Coufal, MD, CEO, Toragen, outlines the scientific foundation and clinical ambitions behind TGN-S15 and her team's HPV-focused research, highlighting the exceptional expertise guiding their work and the significant unmet medical need they are working to address.

Central to the effort is Aldo Venuti, chairman of the scientific advisory board and a leading global authority on the HPV E5 protein. His institution, the Regina Elena Institute in Rome, serves as a sub-awardee on a Gates Foundation grant and provides crucial access to a rare precancerous cervical cell line originally licensed from the University of Cambridge.

This cell line is pivotal because it could allow the team to test their drug candidate against abnormal pap smear diagnoses. As Dr. Coufal explains, "If you could successfully treat abnormal Pap smears, over 99% of which are from HPV infection altering the cells, then you wouldn't have to have partial cervical resections." Such resections, when extensive, can lead to an incompetent cervix and loss of the ability to carry a pregnancy.

HPV is the most frequently transmitted sexual infection, affecting approximately 85% of sexually active people, with 10% unable to clear the virus on their own and no routine blood test yet exists to identify who those individuals are.

Rounding out the advisory team are Dr. Ezra Cohen, lead investigator on Keytruda trials in HPV-positive head and neck cancer; Dr. Penelope Duerksen-Hughes, an expert in HPV E5 and E7 proteins; and Dr. Bill DeGrado of UCSF, whose chemistry expertise continues to advance the program.

Videos

Cheryl Barton is director of PharmaVision, 

Medicines in the European Union. Country flag and pills close up. | Image Credit: ©Verrone -stock.adobe.com

On 12 May 2026, the European Commission (EC) welcomed the landmark policy agreement on the Critical Medicines Act (CMA).

 The proposed EC CMA is one of the most significant industrial policy measures in the European pharmaceutical sector in recent decades. Launched in March 2025 as part of the larger European Health Union initiative, the CMA seeks to improve the availability, manufacturing, and supply security of essential medicines throughout the European Union (see 

 The initiative was launched in reaction to ongoing medicine shortages, geopolitical unrest, and insights gained from the COVID-19 pandemic, highlighting Europe’s reliance on external providers for APIs and essential medicines.

Figure: Key Features of the Critical Medicines Act (Figure courtesy of the author)

The CMA significantly shifts the strategic focus of pharmaceutical manufacturing in Europe. Traditionally, procurement processes in many European Union countries emphasized low costs, often favouring large-scale offshore production in Asia, especially in China and India.

 The new framework emphasizes supply security, resilience, diversification, and regional manufacturing capacity. During the next 5-10 years, this policy shift is likely to impact pharmaceutical development strategies, manufacturing sites, procurement approaches, and investment decisions throughout the European life sciences sector.

From Cost Efficiency to Supply Resilience

A key transformation in the CMA is shifting from procurement systems focused mainly on price competition. The CMA now includes resilience-related criteria, enabling EU governments to prioritize suppliers that have diversified and secured manufacturing networks, contingency capacity, and production within Europe.

 This change is likely to impact pharmaceutical economics throughout Europe. Manufacturers that once relied on highly centralized production outside Europe might now experience strategic pressure to regionalize parts of their manufacturing processes. Companies producing antibiotics, sterile injectables, insulin, vaccines, and other essential medicines may need to invest more in European API synthesis, fill-finish processes, and packaging to stay competitive in EU tenders.

The policy also promotes “strategic projects” that benefit from expedited regulatory processes, simplified access to financing, and possible state aid.

 These incentives could greatly reduce obstacles for manufacturers aiming to set up domestic or regional production in Europe. In practical terms, this suggests that the pharmaceutical sector might favour more modular manufacturing approaches instead of depending on a few large global production centres.

Implications for Decentralized and Distributed Manufacturing

The CMA might significantly accelerate investment in decentralized or distributed pharmaceutical manufacturing systems. Traditionally, pharmaceutical production has favoured very large central facilities to maximize economies of scale. Yet these plants are susceptible to supply disruptions, transport delays, trade conflicts, pandemics, and regional political instability. Distributed manufacturing offers an alternative, with smaller, modular facilities located closer to demand centres. These facilities can quickly adjust production levels and switch products during emergencies. Within the CMA framework, this flexibility is strategically important because resilience delivers economic and regulatory benefits.

According to Carol Houts, CEO of Germfree, Belgium/US, “The CMA signals a shift in how Europe thinks about pharmaceutical manufacturing. In the past, strategies have predominantly focused on cost optimization, global sourcing, and consolidated supply chains. The CMA is really moving towards resilience, regional capacity, supply security, and the ability to respond when global systems are disrupted.”

Advanced continuous manufacturing technologies are especially important here.

 They reduce plant size, lower inventory needs, and enable flexible production scaling. Unlike traditional batch methods, modular continuous systems can usually be set up more quickly and duplicated across different sites.

 In the coming decade, Europe is likely to see heightened investment in modular API production facilities, portable fill-finish systems, and hybrid digital manufacturing networks. This trend corresponds with wider European industrial policy aims centred on “strategic autonomy.”

 Policymakers are increasingly concerned that over 80% of certain antibiotic APIs used in Europe are sourced from Asia.

 A manufacturing network spread across multiple locations can help reduce risks linked to export bans, shipping delays, or regional emergencies.

Modular Manufacturing and Rapid Deployment Capacity

The CMA’s focus on preparedness and supply continuity highlights the potential benefits of modular and quickly deployable manufacturing facilities. Modular manufacturing uses prefabricated units that can be installed, expanded, or relocated more quickly than conventional pharmaceutical plants. These systems could be particularly useful during health emergencies or supply shortages. Modular manufacturing platforms are currently under consideration for vaccines, sterile injectables, biologics, and advanced therapy medicinal products (ATMPs). Looking ahead, the CMA might encourage public-private partnerships to invest in additional manufacturing infrastructure spread across multiple EU member states.

 These facilities could operate at reduced capacity during regular times but quickly ramp up production in emergencies.

Digitalization will play a key role in this transformation. Technologies such as automation, process analytical technologies (PAT), and AI-driven quality monitoring can help smaller facilities achieve regulatory compliance similar to large centralized plants.

 This approach may lower operational risks and support distributed production across different locations. The advantages go beyond just resilience. Decentralized manufacturing has the potential to shorten lead times, cut transportation emissions, and enhance medicine availability in smaller or underserved European markets. Nevertheless, implementing these systems will require significant harmonization of regulatory oversight, workforce training, cybersecurity infrastructure, and quality assurance frameworks across EU member states.

The CMA also encourages collaborative procurement and cross-border cooperation among member states.

 This collaborative approach could expand into manufacturing ecosystems that include pharmaceutical firms, contract development and manufacturing organizations (CDMOs), hospital networks, academic institutions, and regional health systems. These collaborative approaches could be particularly vital for advanced therapies, personalized medicines, and niche critical drugs, where production volumes are low but clinical need is urgent. Regional manufacturing clusters might integrate local production with shared logistics, digital infrastructure, and clinical services.

“Over the next 5 to 10 years, we'll see a shift as European manufacturers and health systems start to work more collaboratively, geographically,” Houts agrees. “Global supply chain issues are not necessarily confined to a single region, and challenges may differ across regions worldwide. It's going to require strong support from countries and initiatives to bring these manufacturing capabilities to fruition, particularly in APIs. APIs are quite inexpensive to produce at scale in places like India and China, but reproducing them in Europe or the United States is extremely expensive.”

For instance, collaborations between pharmaceutical companies and hospital-based manufacturing centres can facilitate decentralized production of cell and gene therapies. Because these treatments typically have very short shelf lives and require highly personalized manufacturing, producing them closer to patients could help minimize transport delays and maintain product quality. The CMA may promote the creation of resilient manufacturing ecosystems instead of standalone production facilities.

 In this approach, pharmaceutical resilience relies not just on physical plants but also on collaborative networks that can quickly coordinate supply, demand forecasting, and emergency response.

Implications for Advanced Therapies and Point-of-Care Production

Over the next decade, the CMA could serve as a key driver for advanced manufacturing technologies and point-of-care pharmaceutical production. Cell and gene therapies are already challenging traditional centralized manufacturing models, as they are often patient-specific, time-sensitive, and logistically complex. Point-of-care manufacturing refers to the creation of therapies directly within or near hospitals and treatment centres. The CMA’s focus on regional resilience and localized production could naturally support this growing approach. Europe might increasingly invest in small, automated manufacturing systems designed to produce autologous cell therapies near the patient’s bedside.

Similarly, modular manufacturing systems for small molecules could involve providing mini factories, in which highly automated facilities generate essential medicines on demand at regional levels.

 These systems might heavily depend on continuous flow chemistry, robotics, and digital quality management. Regulatory frameworks will need to adapt accordingly. The European Medicines Agency is already emphasising manufacturing resilience and digital innovation.

Upcoming European regulations might become more flexible, supporting decentralized manufacturing validation, remote monitoring, and real-time release testing. Importantly, the CMA does not suggest Europe achieve total pharmaceutical self-sufficiency. International collaborations continue to be a component of the strategy.

 Nonetheless, there is a notable move towards diversification and less reliance on single external suppliers.

The CMA represents a significant strategic change in European pharmaceutical policy. Instead of seeing medicines merely as market commodities, the EU now considers them vital public health resources that need a robust regional infrastructure. In the coming 5-10 years, this transition is expected to boost investments in European manufacturing capacity, decentralized production systems, modular facilities, and collaborative pharmaceutical networks.

“I think that distributed manufacturing, whether through regional manufacturing hubs or point-of-care, is going to be necessary to address both drug shortages and expand access,” says Houts.

For pharmaceutical manufacturers, the CMA could fundamentally reshape the basis of competitive advantage. Factors such as supply resilience, geographic diversification, digital manufacturing capabilities, and regional integration might become as vital as manufacturing cost efficiency. Companies that integrate advanced manufacturing technologies with flexible regional supply networks are likely to gain a competitive edge in the evolving European regulatory and procurement landscape. At the same time, the CMA could accelerate the adoption of modular manufacturing, continuous processing, and point-of-care production technologies, particularly for advanced therapies and essential medicines. If implemented effectively, the CMA could position Europe as a global leader in resilient pharmaceutical manufacturing, enhancing long-term medicine security for European patients.

EMA. EMA welcomes political agreement on the Critical Medicines Act

12 May 2026. https://ec.europa.eu/commission/presscorner/detail/en/ip_26_1017

 11 March 2025. https://health.ec.europa.eu/publications/proposal-critical-medicines-act_en

Critical Medicines Act: Council agrees its position on new rules to tackle shortages

 2 December 2025. https://www.consilium.europa.eu/en/press/press-releases/2025/12/02/critical-medicines-act-council-agrees-its-position-on-new-rules-to-tackle-shortages/pdf

Critical Medicines Act: Council and Parliament reach provisional deal

https://www.consilium.europa.eu/en/press/press-releases/2026/05/12/critical-medicines-act-council-and-parliament-reach-provisional-deal/pdf

EU announces plans to cut reliance on Asia for antibiotics and critical drugs

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-announces-plans-cut-reliance-asia-antibiotics-other-critical-drugs-2025-03-11

https://health.ec.europa.eu/medicinal-products/critical-medicines-act_en

EU agrees draft deal to tackle essential medicine shortages

https://www.reuters.com/sustainability/boards-policy-regulation/eu-reaches-provisional-deal-address-shortage-essential-medicines-2026-05-12

Modular and reconfigurable factories for continuous production innovation in pharmaceutical manufacturing.

https://doi.org/10.1080/00207543.2025.2575844

Regulatory perspectives on continuous pharmaceutical manufacturing

https://doi.org/10.1016/j.xphs.2017.06.015

Schaber S.D., et al. Economic analysis of integrated continuous and batch pharmaceutical manufacturing: a case study.

 2011;50(17):10083-10092. https://www.research.ed.ac.uk/en/publications/economic-analysis-of-integrated-continuous-and-batch-pharmaceutic/

Future of pharmaceutical industry in Europe: Addressing strategic autonomy, API production, affordable medicines and unmet needs.

https://www.eesc.europa.eu/en/our-work/opinions-information-reports/opinions/future-pharmaceutical-industry-europe-addressing-strategic-autonomy-api-production-affordable-medicines-and-unmet-needs/related-links-ccmi-212

New CMA proposals to drive growth, investment and business confidence. Competition and Markets Authority

. Blog. 13 February 2025. https://competitionandmarkets.blog.gov.uk/2025/02/13/new-cma-proposals-to-drive-growth-investment-and-business-confidence/

Regulatory and quality considerations for continuous manufacturing

The Industrial Forum. Advanced Manufacturing at the heart of a resilient, sustainable and competitive Europe. Recommendations by the EU Industrial Forum. 12 June 2023. 

tf5-report-final-version--12.06.2023-3.pdf

Modulus: Redefining Biopharma Manufacturing

. 8 October 2025. Accessed 25 May 2026. https://www.sanofi.com/en/magazine/ai-in-healthcare/modulus-redefining-the-future-of-biopharma-manufacturing

. 18 June 2025. Accessed 25 May 2026. https://www.eesc.europa.eu/en/our-work/opinions-information-reports/opinions/critical-medicines-act

Cheryl Barton, PhD, is the founder and director of PharmaVision, Pharmavision.co.uk.

The EU’s Critical Medicines Act signals a major industrial-policy pivot from lowest-cost sourcing to supply security for essential medicines. Resilience criteria in procurement, coupled with incentives for “strategic projects,” are expected to drive investment in European API, fill-finish, and packaging capacity. The framework favors decentralized and modular manufacturing, continuous processing, and digitally enabled quality oversight to improve agility during disruptions. Cross-border collaboration and manufacturing ecosystems may expand, with particular relevance for vaccines, antibiotics, sterile injectables, and point-of-care cell and gene therapies.

The CMA will improve Europe’s manufacturing resilience and lead to greater diversification and reduced reliance on single external suppliers.

The Critical Medicines Act’s Impact on Pharmaceutical Manufacturing and Supply Resilience in Europe

Lilly Agrees to Acquire 3 Pharma Firms for a Combined $3.8B

On May 26, 2026, Eli Lilly announced agreements to acquire three biotechnology companies—Curevo, LimmaTech Biologics, and Vaccine Company—in deals valued collectively at up to $3.83 billion.

 The transactions signal a deliberate expansion into infectious disease prevention, with each acquisition targeting a distinct pathogen class and technology platform.

The strategic thread connecting all three deals is the concept of upstream intervention.

 Rather than developing treatments for conditions like dementia or multiple sclerosis directly, Lilly is investing in preventing the infections implicated in their development, which can represent a more efficient path. Shingles vaccination, for instance, has been associated in population studies with reduced dementia risk, and there is growing evidence linking the Epstein-Barr virus to multiple sclerosis and several malignancies. The framing of vaccines being tools for reducing long-term disease burden rather than simply preventing acute infection, has implications for how these treatments will be positioned in development and eventually in regulatory submissions.

Eli Lilly is expanding infectious disease prevention via acquisitions of Curevo, LimmaTech Biologics, and Vaccine Company totaling up to $3.83B, emphasizing “upstream” risk reduction for chronic disease. Curevo’s shingles candidate aims to maintain immunogenicity while improving tolerability using a synthetic adjuvant. LimmaTech adds bacterial toxoid/superantigen–focused vaccines for AMR-threat pathogens with distinct scale-up constraints. Vaccine Company contributes a nanoparticle antigen-display platform for a phase 1–ready multiantigen EBV program. Parallel oncology efforts reflect earlier, targeted intervention across modalities.

Lilly acquires three biotech firms for up to $3.83 billion, targeting vaccines that may prevent not just infection but also downstream neurological and oncological disease.

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