Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

Artificial intelligence, machine learning, and novel instruments are helping drug developers.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

J.P. Morgan Report Lists Biologics, Obesity, China

Top Trends Reshaping Pharma R&D

Feliza Mirasol is the science editor for 

Unidentified microbiologist is place the petri dish and tubes into incubator to incubate the culture of bacteria or fungi growth in appropriate condition, concept of microbial laboratory. | Image Credit: © Sukjai Photo – © Sukjai Photo – Stock.Adobe.com

Maintaining a sterile cleanroom environment and stringent cleanroom protocols in biopharmaceutical manufacturing are critical to ensure optimal product quality and, ultimately, patient safety. With the shift toward personalized medicines, new generation therapies, such as messenger RNA (mRNA), cell and gene therapies (CGTs), antibody-drug conjugates, and modern vaccines, are presenting sterility challenges. Therefore, it is becoming increasingly necessary for analytical technologies to advance and keep pace with the evolving, modern-day therapeutic requirements for sterile environments in cleanrooms.

As therapeutic modalities evolve, so do the challenges and methodologies associated with maintaining and verifying cleanroom sterility. Cleanroom standard operating procedures (SOPs) are the foundation to ensuring controlled, contaminant-free environments. Recent regulatory updates have prompted revisions to these procedures to align with contemporary standards and technological advancements.

For example, the International Organization for Standardization (ISO) updated the ISO 14644 series in 2015 (1), which delineates cleanroom classifications and associated protocols. In the series, ISO 14644-1 focuses on classifying air cleanliness by particle concentration, and ISO 14644-2 enumerates the requirements for testing and monitoring to ensure ongoing compliance with designated cleanliness levels. With these updates, a more rigorous approach to contamination control is emphasized, which necessitates that SOPs incorporate enhanced monitoring and maintenance strategies (1).

FDA, meanwhile, has advocated for integrating rapid and advanced detection methods into sterility testing, with the goal of expediting detection of microbial contaminants and reducing product release times without compromising safety. As a result, SOPs now often include provisions for implementing rapid microbiological methods (RMMs) alongside traditional testing techniques (2).

Sustaining sterility within cleanrooms poses multifaceted challenges, both enduring and emerging. Challenges that continue to persist include:

 Personnel remain the primary source of contamination. This is commonly attributed to inadequate gowning procedures, lapses in protocol adherence, and insufficient training—all of which can introduce particulates and microbes into the cleanroom environment (3).

Continuous surveillance of particulate and microbial levels is crucial; however, traditional monitoring methods may not provide real-time data, which potentially allows contaminants to proliferate before detection (4).

 Suboptimal cleanroom design or maintenance can lead to contamination risks. Improper airflow, inadequate filtration systems, and poorly maintained equipment are factors that can compromise sterility (5).

Meanwhile, emerging challenges posed by new therapeutic modalities, such as CGTs and mRNA-based treatments include:

 These new modalities often involve living cells or delicate nucleic acids, which are highly susceptible to environmental conditions. Therefore, maintaining appropriate temperature, humidity, and aseptic conditions is paramount.

 Production of these modalities typically involves intricate procedures, which increases the potential for contamination at multiple stages of the manufacturing process. Each step necessitates stringent controls to preserve product integrity.

 Many advanced therapies have limited shelf lives, necessitating expedited manufacturing and testing processes. Traditional sterility testing methods, which can take up to 14 days, are impractical for these products, prompting the need for rapid testing alternatives (6).

On the other end of contamination prevention is verification of sterility, which is also a critical step to ensuring a product’s safety and efficacy. Verification requires analytical testing methods, including membrane filtration, direct inoculation, and automated culture systems.

In membrane filtration, product is passed through a filter that captures potential contaminants. The filter is then incubated in growth media to detect microbial presence (7). Direct inoculation is applied to products that cannot undergo filtration. In this method, product is directly inoculated into culture media, incubated, and microbial growth is monitored over a specified period of time (8). Meanwhile, automated culture systems were developed to enhance efficiency and reliability. In these systems, product is continuously monitored for microbial growth. This method offers advantages in sensitivity and reduced hands-on time compared to manual methods (9).

The evolving regulatory requirements over the years as well as the increasing biopharmaceutical complexity and growing demand for aseptic processing have prompted significant advancements in cleanroom technologies and analytical testing methods. These innovations have been driven by the need for faster, more accurate contamination detection, improved environmental monitoring, and greater flexibility in biomanufacturing. Innovations include rapid microbiological methods (RMMs), next-generation sequencing (NGS), real-time environmental monitoring, and the use of digitalization and artificial intelligence (AI) in cleanroom analytics.

The adoption of RMMs has been prompted by the lengthy time it takes for traditional sterility testing methods. For example, membrane filtration and direct inoculation can take up to 14 days to get results. RMMs utilize technologies such as nucleic acid amplification (e.g., polymerase chain reaction-based assays), flow cytometry, and adenosine triphosphate bioluminescence to detect microbial contaminants in real-time or within hours rather than days (4). Advanced therapies such as CGTs and mRNA-based therapeutics require faster contamination detection than traditional methods and have been the real drivers behind accelerating the implementation of RMMs.

NGS, meanwhile, has emerged as an important tool for microbial identification in cleanrooms as it enables the detection and characterization of diverse microbial populations, unlike conventional culture-based methods. NGS also enables the detection of previously unculturable organisms. This technology enhances contamination tracing and root-cause investigations and can lead to more effective contamination control strategies (10).

Real-time environmental monitoring has been enabled with the development of advanced sensors. The ability to monitor particles and microbes in real time is changing the way contamination control is handled in the cleanroom. For example, technologies such as laser-induced fluorescence sensors allow for immediate airborne microbial detection without the need for culture-based methods. Systems such as those are often integrated into continuous environmental monitoring platforms and provide instant alerts to deviations in cleanroom conditions (2).

Finally, AI-driven analytics, combined with machine learning algorithms, are being deployed to analyze environmental monitoring data, detect contamination patterns, and predict contamination risks before they occur. Having this predictive approach enables proactive decision-making and reduces the risk of contamination events, which in turn minimizes production shutdowns (11).

Cleanrooms and Associated Controlled Environments Standards

 (2015).
2. Thermo Fisher Scientific. Rapid Sterility Testing: Overcoming Challenges in Cell Therapy Production. 

Cleanroom Technology: Fundamentals of Design, Testing and Operation

; Wiley, 2010.
4. Agalloco, J.; Akers, J. 

Advanced Aseptic Processing and Biopharmaceutical Manufacturing

Cleanroom Microbiology for the Non-Microbiologist

; CRC Press, 2019.
6. Jallow, J. Rapid Sterility Testing for Cell and Gene Therapy Treatments. 

 (Rockville, Md., 2023).
8. PDA. Sterility Testing of Pharmaceutical Products. 

 (2019).
9. Khuu, H. M; Stock, F.; McGann, M.; et al. Comparison of Automated Culture Systems With a CFR/USP-Compliant Method for Sterility Testing of Cell-Therapy Products. 

 (3), 183–195. DOI: 10.1080/14653240410005997
10. Xiao, Y.; Zhang, L.; Yang, B.; et al. Application of Next Generation Sequencing Technology on Contamination Monitoring in Microbiology Laboratory. 

 (1), 25–31. DOI: 10.1016/j.bsheal.2019.02.003
11. Bradshaw, N. Using AI and Machine Learning in Cleanroom Contamination Control. 

®
Vol. 49, No. 4
May 2025
Pages: 28–29

When referring to this article, please cite it as Mirasol, F. Evolving Cleanroom Procedures and Sterility Challenges. 

Articles

The shift toward personalized medicines poses new challenges in cleanroom protocols.

Evolving Cleanroom Procedures and Sterility Challenges

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

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GSK is preparing to present data from its respiratory portfolio in more than 40 abstracts at the 2025 edition of the American Thoracic Society (ATS) International Congress, which will be held in San Francisco from May 16–21 (1).

Among a list of 43 scheduled abstracts, including four late-breaking submissions, GSK in a press release on May 2, 2025 offered details on 26 “key presentations” to be made at the event, five of which will be given orally (1). This group of presentations, GSK said, will largely focus on optimal patient care that facilitates prevention and treatment of diseases such as asthma and chronic obstructive pulmonary disease (COPD).

Two of the treatments that will be receiving plenty of attention in GSK’s presentations are mepolizumab and depemokimab, which are both monoclonal antibodies (mAbs) that target IL-5, a key cytokine or messenger protein in asthma with type 2 inflammation. Phase III trials (MATINEE for mepolizumab and SWIFT-1 and SWIFT-2 for depemokimab) have assessed the efficacy and safety of their respective medications in treating type 2 inflammation and, in mepolizumab’s case, COPD (1).

Mepolizumab is currently approved for use in the United States and Europe across four IL-5 mediated diseases, but not for treatment of COPD. Depemokimab is an investigational product that has not yet been approved for use in any country, according to GSK (1).

Meanwhile, GSK has received approvals for several treatments in other areas so far in 2025.

In April 2025, the United Kingdom’s Medicines and Healthcare products Regulatory Agency 

 (brand name Blenrep), an antibody-drug conjugate that comprises a humanized B cell maturation antigen mAb conjugated to the cytotoxic agent auristatin F via a non-cleavable linker, for treatment of adults with multiple myeloma in either of two combinations: with bortezomib plus dexamethasone for patients who have received at least one prior therapy, and with pomalidomide plus dexamethasone for those who have received a prior therapy including lenalidomide (2). Prior to that, in February, FDA 

 for meningococcal disease groups A, B, C, W, and Y, marketed as Penmenvy, for use in individuals aged 10 through 25 in the US (3).

GSK has also announced numerous partnerships and collaborations since the fourth quarter of 2024: 

 with the University of Cambridge and Cambridge University Hospitals to treat immune-related diseases with existing as well as newly-developed therapies, particularly kidney and respiratory diseases; 

 with Relation, a UK-based platform biotechnology company, for the identification and validation of novel therapeutic targets for fibrotic diseases and osteoarthritis, and Muna Therapeutics, a Denmark-based biotech, to identify and validate novel drug targets for the treatment of Alzheimer’s disease; and 

 with the University of Oxford that will focus on the potential of cancer prevention through vaccination (4–7).

1. GSK. GSK Continues to Advance the Future of Respiratory Medicine and Patient Care with New Data at ATS. Press Release. May 2, 2025.
2. GSK. Blenrep (belantamab mafodotin) Combinations Approved by UK MHRA in Relapsed/Refractory Multiple Myeloma. Press Release. April 21, 2025.
3. GSK. Penmenvy, GSK’s 5-in-1 Meningococcal Vaccine, Approved by US FDA to Help Protect Against MenABCWY. Press Release. Feb. 15, 2025.
4. GSK. GSK and Cambridge University Announce New Five-Year Collaboration in Kidney and Respiratory Disease. Press Release. Oct. 21, 2024.
5. Relation. Relation Announces Two Strategic Collaborations with GSK to Advance Therapeutics for Fibrotic Diseases and Osteoarthritis. Press Release. Dec. 10, 2024.
6. Muna Therapeutics. Muna Therapeutics Announces Strategic Alliance with GSK to Accelerate Development of Novel Treatments for Alzheimer’s Disease. Press Release. Dec. 5, 2024.
7. GSK. GSK and Oxford Establish the GSK-Oxford Cancer Immuno-Prevention Programme to Advance Novel Cancer Research. Press Release. Jan. 27, 2025.

The company is presenting data related to its medications designed to advance the prevention and treatment of asthma and COPD.

GSK Previews Oral and Poster Abstracts for ATS International Congress

Image Credit: © Kiattisak – stock.adobe.com

A January 2025 report from Vector, a United Kingdom-based recruitment process outsourcing (RPO) partner for pharmaceutical contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), defined five main trends to watch for regarding outsourcing within the bio/pharmaceutical industry itself (1). Skill specialization, regulatory complexities, the perpetuance of remote and hybrid work, 

the meteoric rise of artificial intelligence (AI) technologies,

 and talent retention were all given their place in the pharma workforce of the future.

At least one of these factors—a continued reduction in in-office work—is a stubbornly lingering aftereffect of the COVID-19 pandemic. Erik Wiklund, CEO of Circio, called it the “COVID bubble,” a “nuclear winter” of sorts for smaller biotech companies that made capital difficult to access and caused massive layoffs in the United States and Europe (2).

However, Wiklund sees the winds of change shifting for Circio, and believes the experiences his company has been through in the past five years mirror those of countless industry peers.

“Many companies launch great ambitions, large valuations,” Wiklund explained (2). “People flow into the industry, and then the breaks set in, but then what happens is that the companies that survive, they then suddenly have access to a broad talent pool, and then the capital comes back.”

Central to that broadening of talent, opined Sheryl Johnson, pharma application development manager at Orbia Fluor & Energy Materials, should be endeavoring to continue the strides the industry has made toward diversity, equity, and inclusion—keeping in mind that the pharmaceutical world encompasses far more than the US, where those buzzwords have come under political scrutiny (3).

Johnson says Orbia is taking a variety of proactive approaches to improve gender-diverse representations within their workforce, but full diversity will take ongoing cooperation throughout the field.

“Women, in particular, can bring unique perspectives, talents, [and] approaches that can drive innovation, particularly in the pharma industry,” Johnson said (3). “Female leaders can often excel in collaborative and inclusive leadership styles, which I feel can help foster creativity and new ideas. I find women are very open to sharing of new ideas and provide supportive attitude to research management and development through considered and empathetic communication.”

As part of its coverage of both the International Day of Women and Girls in Science on February 11 and International Women’s Day on March 8, 

® conducted a series of interviews with leading women in the bio/pharma space, Johnson included, explaining some reasons for a gender gap in science, technology, engineering, and math (STEM) that has skewed the balance of skilled workers heavily to the male side, and offering potential ways the industry can foster and incentivize female involvement (4).

While Sabine Gölden, eLearning & Training Lead at the European consulting firm MAIN5, said educational STEM programs aim to provide equal access to all without being gender-specific, she added that persistent stereotypes of what are traditionally seen as gendered career paths should be understood by females at a young age—especially when programs exist that challenge them to break out of those norms (5).

“Scientific research shows that there are cognitive differences and varying talents between men and women,” Gölden said (5). “As a result, some individuals may naturally have advantages in this or that topic or might suit better in a specific position. These talents follow a Gaussian (‘normal’) distribution, and men are more likely to have cognitive advantages for STEM-related work—but women are still underrepresented in these fields.”

Yet to return to another of the Vector report’s key points, talent retention remains a major hurdle. And it may not always be, as in Wiklund’s “COVID bubble” example, the sole burden of the industry, or any specific company.

Gölden said the “work-motherhood challenge” is still one that women are fighting, even within themselves, across various workforces (5). She calls it a “leaky pipeline,” one that may have an unconventional fix.

“Even today, it’s still uncommon for women to be the primary breadwinners and men to take on the role of caretakers,” she said (5). “From my perspective, this is where the biggest challenge lies. It’s not just about providing opportunities and empowerment for women; it’s about breaking down the barriers for men, who often face potential career and reputation impacts when they take on caretaker roles."

The reputations of human workers of all backgrounds could figure to be at stake in the next several years as AI impacts more corners of the industry. Wiklund is in lockstep with the Vector report in theorizing that AI’s most likely usefulness in the near term will be in the earliest stages of the R&D process, such as drug development (1,2). But as far as human decision-making, Wiklund believes the technology’s intrusion is still a long way off.

“Maybe the area which appears most obvious is in diagnostics and prognostics, where an artificial intelligence can start utilizing information and colliding information in a more systematic way, using radiology and other types of scans to give better and more reliable interpretations,” he said (2). “That probably is where artificial intelligence will make an impact first. But again, the business models are not really established yet. The regulatory frameworks are not there yet. So ... I think it’s going to take longer than 2025 for us to start really seeing [the] big impact of this when it comes to therapeutic development, or the real impact on treatment decisions.”

 can only benefit human professionals, and gender diversity plays a distinct role in that as well. Programs such as Girls Who Code, which helps girls build coding and AI skills, are gateways for women in healthcare industries who now must compete against machine as well as man, according to Jean Redmond, chief operating officer at Biologit (4). But there’s a higher purpose here, too: preparing those women to be the decision-makers that Wiklund said AI is not yet ready to usurp.

“By increasing representation in STEM fields, these initiatives help drive diversity in leadership and innovation in pharma and biotech,” Redmond said (4). “Additionally, mentorship, networking, and industry partnerships further support women in transitioning from education to impactful careers.”

As the US rewrites its tariff policies early in the second Trump Administration, companies in Europe and other parts of the world may look elsewhere for development opportunities, according to Wiklund. So even as access to talent is improving five years post-COVID, where people are looking for new work, and which companies will partner with them, and each other, remain question marks.

“Increasing cost levels in the US in particular, [a] strong dollar, and increasing inflation [have] driven up prices,” Wiklund explained, also adding that “it’s become cheaper by comparison to develop drugs in Europe, Asia, [and] Australia, and I think maybe if that trend continues with a strong US economy and increasing prices, then you may see that that kind of European, eastward-oriented trend continuing” (2).

Will the geopolitical climate, artificial intelligence, gender imbalances, or the flexibility of working environments prove to be headwinds or tailwinds for finding, developing, and retaining talent? Finding a definitive answer that fits any of those factors is neither easy nor certain. Skilled workers are out there to be had, but how bio/pharmaceutical companies treat them and encourage their career growth is a destination to which there are many different paths.

1. Kelly, N. The Future of Pharma Outsourcing: Trends Reshaping the Talent Landscape in 2025. 

, Jan. 23, 2025.
2. Thomas, F. and Haigney, S. Industry Outlook 2025: Talent Up for Grabs. 

, April 10, 2025.
3. Thomas, F. International Women’s Day 2025: A Promising Future for Gender Diversity in Pharma. 

, March 8, 2025.
4. Haigney, S. Leaving STEM Skills on the Table. 

, Feb. 13, 2025.
5. Haigney, S. International Day of Women and Girls in Science 2025: Inspiring and Supporting Women in STEM. 

®
Vol. 49, No. 4
May 2025
Pages: 30–31

When referring to this article, please cite it as Lavery, P. Authentic Intelligence: Finding Diverse Talent in the Age of AI. 

The bio/pharmaceutical industry is experiencing significant shifts in outsourcing trends, driven by factors such as skill specialization, regulatory complexities, remote work, AI advancements, and talent retention. The COVID-19 pandemic has left a lasting impact, particularly on work environments and capital access. Diversity, equity, and inclusion are emphasized as crucial for innovation, with a focus on increasing female representation in STEM fields. AI is expected to impact early R&D stages, but human decision-making remains vital. Geopolitical factors and economic conditions influence talent acquisition and development strategies across global markets.

The pandemic made it daunting for companies to retain talent and then find it anew, but just as that cloud is lifting and workforce diversity is being embraced, AI beckons as a new challenge.

Authentic Intelligence: Finding Diverse Talent in the Age of AI

Cheryl Barton is director of PharmaVision, 

Landkarte *** Europa | Image credit: ©beugdesign - Stock.adobe.com

On 29 Jan. 2025, the European Parliament (EP) held a public hearing to discuss ways to support the production of APIs and finished medicines within Europe (1). The European Union (EU) faces a growing challenge in securing its supply of essential pharmaceuticals, with the majority of its APIs and finished medicines currently imported from Asia, namely India and China.

This article was published in the May 2025 issue of 

APIs play a pivotal role in the pharmaceutical industry. They are essential for the efficacy and safety of drugs. The quality of APIs directly impacts the effectiveness of the final drug product (2). Whilst the globalization of the medicines supply chain has helped to increase access to cheap, high-quality medicines, the supply chain has grown longer, more complex, and fragmented, and countries have become more reliant on overseas API suppliers (2).

The European API sector is considered highly competitive, given its technical know-how and strong workforce capacities (3). API manufacturing is an important sector, generating €60 billion per year and employing more than 150,000 people throughout Europe (3). Over the past two decades, Europe’s API manufacturing capabilities have decreased from 42% share of the market in API Drug Master Files (DMFs) in 2000 to 10% in 2023, highlighting the long-term trend of decreasing API manufacturing activity within Europe (

). There has also been a shift of small-molecule APIs and related intermediates production towards Asia, and more than 74% of the European medicine value chain depends on imports (

Figure 1: Active API Drug Master Files by region, 2000, 2023. Figure courtesy of the author

Whilst India remains the market leader in API manufacturing, China has exhibited strong growth and expanded its role in global API production, accounting for almost one-third of all DMF filings in 2023 (4). These findings underscore the importance of monitoring the pharmaceutical supply chain to understand and adapt to market dynamics and reduce any perceived threats that the EU’s reliance on API imports may have on public health in the Member States.

Figure 2: European supply chain (base 100, 2023). Figure courtesy of the author.

Reshoring pharmaceutical production in Europe and promoting geographic diversity in API manufacturing will help reduce supply chain vulnerabilities and the risk of drug shortages (5). This was the conclusion of the Environment, Public Health and Food Safety report, Potential Measures to Facilitate the Production of Active Pharmaceutical Ingredients (APIs), published in March 2023 (5). The study confirmed that reshoring would require financial support from governments to the pharmaceutical industry, but this was not the only factor. Further solutions were proposed including agreements with local chemical suppliers (e.g., key materials), the consideration of fee or tax benefits, the development of new production technologies to accelerate automation and reduce labour costs, incentives to encourage the use of environmentally friendly technologies, the creation of training and programmes to develop workforce needs, and the alignment of existing policies (6).

On 11 Mar. 2025, the European Commission (EC) took the first step in this direction and proposed the Critical Medicines Act, setting out a plan to improve medicine procurement, provide subsidies for drug production, and improve supply chains to reduce the risk of drug shortages (7). But time is running out.

The EU needs to move quickly or risk a manufacturing exodus to the US

In April 2025, the European Federation of Pharmaceutical Industries and Associations issued a stark warning that “unless Europe delivers rapid, radical policy change, then pharma research, development, and manufacturing is increasingly likely to be directed towards the [United States]” (8). The CEOs of the research-based pharmaceutical industry called for immediate action on:

adopting a world-leading regulatory framework conducive to innovation

achieving a competitive EU market that attracts, values, and rewards innovation in line with other economies at the forefront of patient care

ensuring policy coherence across environmental and chemical legislation to secure a resilient manufacturing and supply chain of medicines in Europe

strengthening rather than weakening Europe’s intellectual property provisions (8).

In the meantime, the uncertainty created by the threat of US tariffs on pharmaceuticals means there are limited incentives for pharma to invest in the EU and a significant push to relocate to the US. In the past month, several pharmaceutical companies—Eli Lilly, Johnson & Johnson, Merck, Novo Nordisk, and Novartis—have announced their plans to expand manufacturing facilities in the US (9). Whilst it may take several years for these sites to become fully operational, it sends a clear message that market dynamics have changed, and the EU will need to move quickly and invest in its pharmaceutical ecosystem, or it will fall behind and be held to ransom by overseas suppliers (8).

EP. Overreliance on Imports of Active Pharmaceutical Ingredients. Committee of Public Health. 29 Jan. 2025.

SEQENS. Enhancing Drug Development: A Comprehensive Guide to API Manufacturing. Seqens.com. 17 Jan. 2025. (accessed 15 Apr. 2025).

Medicines for Europe. EP Hearing on “Overreliance on imports of Active Pharmaceutical Ingredients (APIs)”. Committee for Public Health (SANT) European Parliament. 25 Jan 2025.

Quality Matters. Global Manufacturing Capacity for Active Pharmaceutical Ingredients Remains Concentrated. U.S. Pharmacopeia Blog. 6 Nov. 2024

CHESSMEN. Identifying the Root Causes of Observed Shortages of Medicines. 2024. Ja-chessmen.eu (accessed 16 April 2025).

ENVI. Potential Measures to Facilitate the Production of Active Pharmaceutical Ingredients (APIs). March 2023.

EC. Proposal for a Critical Medicines Act. EC.europa.eu. 11 Mar. 2025

EFPIA. Pharma CEOs Alert President von der Leyen to Risk of Exodus to the US. Efpia.eu. 8 Apr. 2025.

POLITICO. Trump Says Pharma Tariffs Will Entice Back Drug Production. They Won’t. Politico.eu. 14 Mar. 2025.

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

When referring to this article, please cite it as Barton, C. EU to Support the Production of APIs and Finished Medicines within Europe. 

The European Union is discussing ways to reduce Europe’s over-reliance on imports of APIs.

EU to Support the Production of APIs and Finished Medicines within Europe  

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com

Q: We understand that the European Union’s good manufacturing practice (GMP) regulations are quite similar to the US Code of Federal Regulations (CFR). Can you explain some key differences?

A: You are correct that there are many similarities, not least because the United States and the EU have long worked towards global harmonization of GMP regulations. GMP regulations in one form or another have been around for half a century or more, so there has been plenty of time for alignment. The differences in the two regulatory systems are certainly twofold: the specific wording and requirements aren’t identical, and the two entities (US and EU) themselves are distinctly different.

Whereas the US has one CFR that applies as is in all US States, the EU has a regulatory system that is based on Union law and the laws of the 27 Member States (MS). Thus, the EU regulations are only harmonized to some degree, particularly in their interpretation, resulting in many member-state specific requirements and procedures.

Differences between the two regulatory systems are also in their structures. US 21 CFR 211 describes GMP for finished pharmaceuticals in the US. To find the equivalent regulations in the EU, it is easiest to go to EudraLex–Volume 4–Good Manufacturing Practice (GMP) guidelines (1). The EU laws are directives, which need to be transposed into national law in the MS. Though EudraLex provides the consensus interpretation of the directives, each MS can and likely has interpreted some parts slightly differently.

A distinct difference exists with regards to drug product release (to the market). In the US, this is under the authority of the quality control unit (21 CFR 211.22), whereas in the EU this can only be performed by a Qualified Person (QP) (2). The QP can be a member of the quality unit, or even be an independent consultant, depending on the applicable national or regional legal requirements. For certain products (e.g., blood products), an additional release by the Official Control Authority Batch Release is required (3). And should you be confused about the quality unit terminology, please see the article, “The Role of the Quality Unit” (4).

A large number of products are aseptically manufactured. The sterilizing filter is thus a critical component in sterility assurance of the finished product. In the EU, Annex 1 (5) all but mandates that the integrity of the sterilised filter assembly should be verified by integrity testing before use (pre-use post sterilization integrity test or PUPSIT). There is no equivalent requirement in the CFR or FDA guidance documents. PUPSIT is yet another example of differing requirements or expectations.

Tables that compare the EU and US regulations have been created by many a company. These are very useful; however, as shown above, this is not enough to really fully understand the detailed expectations, which are often published in guidances and in the case of the EU may only be available in national or regional communications in the local languages. For a full picture, it is always recommended to consult with the local agencies.

–Volume 4–Good Manufacturing Practice (GMP) Guidelines. https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en

EC. Annex 16–Certification by a Qualified Person and Batch Release. 

–Volume 4, https://health.ec.europa.eu/document/download/20c41532-33d5-4635-ae80-8735d3d09fe0_en?filename=v4_an16_201510_en.pdf

. https://www.edqm.eu/en/omcl/human-biologicals-ocabr-

S. Schmitt. The Role of the Quality Unit. 

EC. Annex 1–Manufacture of Sterile Medicinal Products. 

–Volume 4https://health.ec.europa.eu/document/download/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf

Siegfried Schmitt, PhD is vice president, Technical at Parexel.

When referring to this article, please cite it as Schmitt, S. Complying with European versus US GMPs. 

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Complying with European versus US GMPs 

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On May 1, 2025, Aviva Capital Partners and mixed-use developer Socius announced plans for a new £1 billion (US$1.33 billion) investment to create a cancer research and treatment center in Sutton, London. The 12-acre site will be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.

The plans are to create approximately 1 million square feet of state-of-the-art research and laboratory space where life sciences companies can come together with academic researchers and clinicians to push cancer research forward. The project is expected to create 3000 new jobs including high-skilled R&D and small-scale manufacturing life sciences positions.This will increase the workforce of the London Cancer Hub to 13,000 and contribute £1.2 billion per year to the economy in the United Kingdom.

“We invest to grow the economy, drive regeneration, and create jobs and homes in the UK,” David Epstein, managing director of Aviva Capital Partners, said in a press release (1). “We’re delighted to be investing in world-class cancer research in Sutton. As well as helping the UK to grow and get ready for the future, this investment will be a boost for the local area, with thousands of new jobs created.”

The development will feature large-scale facilities, smaller lab and incubator spaces for start-up companies, wet labs, good manufacturing practice facilities, specialist equipment, and office space. In addition, a Learning Lab will include a classroom and education spaces. Amenities will include restaurants, cafes, and affordable housing for workers. Buildings will exceed sustainability and energy efficiency standards with a net-zero carbon goal.

“There is a unique opportunity at the London Cancer Hub to deliver state-of-the-art lab and research facilities alongside two world-renowned institutions, The Institute of Cancer Research and The Royal Marsden, to supercharge investment into cancer research,” Barry Jessup, managing director of Socius, said the in the release. “Our plans are not just about delivering new facilities to attract cutting-edge businesses, it is about reorienting the district so there is better connectivity between the buildings, more natural ‘collision points’ and places to meet to drive collaboration and innovation.”

The new development will expand the London Cancer Hub, which already includes the Institute of Cancer Research, with more than 1000 scientific and profession staff, and the Centre for Cancer Drug Discovery, which opened in 2021. The Centre has been successful in discovering 21 potential cancer drugs, including 13 that have gone into clinical trials.

“We’re very pleased to be working with Aviva Capital Partners and Socius on plans to further build the thriving multidisciplinary research district in Sutton, and we’re hoping that the project will attract a range of companies to locate here alongside us, as well as provide a home for companies that spin out from our science in the future,” Kristian Helin, chief executive of The Institute of Cancer Research, London, said in the release. “The London Cancer Hub has great potential to enhance our scientific partnerships with companies in the pharmaceutical and broader life-sciences industries, in areas from the discovery and development of new cancer drugs to the creation of new treatment and diagnostic technologies.”

Dame Cally Palmer, chief executive of The Royal Marsden NHS Foundation Trust expressed support for the new project in the press release. “The Royal Marsden’s Sutton site is home to a flourishing research community between The Royal Marsden and The Institute of Cancer Research, London, that consistently translates innovative ideas in drug discovery from the laboratory to the clinical setting for the benefit of cancer patients worldwide,” Palmer stated. “We support the vision for The London Cancer Hub and the investment from Aviva Capital Partners to bring life sciences industry on to the site. We anticipate this will facilitate greater collaboration and foster an environment of excellence to further our work developing new and improved ways to diagnose, treat, and care for our patients.”

“The London Cancer Hub will position Sutton as London’s global center for oncology. Already recognized as a leading life science cluster in the capital, the site’s uniqueness lies in its current delivery of world-class cancer research, discoveries, and treatment all within a single location,” Councillor Bary Lewis, leader of the London Borough of Sutton, said in the release. “The life science sector and associated development will be pivotal to the future growth of the capital over the coming years as recognized by the Mayor of London’s growth plan that names the London Cancer Hub as the key engine for this growth. The submission of this planning application marks a significant step forward in the is exciting development for Sutton and the capital.”

1. Aviva. Aviva Capital Partners and Socius Submit Plans for £1 Billion Development to Create the World’s Leading Centre for Cancer Research and Treatment. Press Release. May 1, 2025.

Aviva Capital Partners and developer Socius are investing £1 billion to develop a cancer research and treatment center in Sutton, London.

Cancer Research and Treatment Center Planned for London

Mike Hennessy Jr. is the Chairman and CEO of 

High Angle Shot of a Working Desk of an Successful Person in Office with Cityscape Window View. | Image credit: © Gorodenkoff - stock.adobe.com

As the pharmaceutical industry moves through a new era of complexity and precision, one truth remains constant: the foundation of every successful therapy is built on quality, consistency, and thoughtful innovation. From raw materials to regulatory harmonization, every link in the supply chain plays a critical role in ensuring that medicines reach patients safely and efficiently.

In this issue’s cover story, “Poor API Quality Threatens a Healthy Supply,” we highlight a pressing vulnerability in the supply chain. As global demand grows and supply networks stretch across borders, even minor lapses in API quality can ripple into major disruptions—slowing production, triggering shortages, and ultimately impacting patient care. Ensuring API integrity is no longer just a manufacturing concern; it’s a business-critical priority.

Product formulation is another key decision point in development. In “Parenteral Formulation: Deciding When to Go Frozen or Freeze-Dried,” we explore how technical performance, cost, and logistics influence formulation strategies. Whether opting for frozen storage or lyophilization, the choice has long-term implications for stability, transport, and scalability.

As in previous issues, sustainability continues to be a recurring and essential theme. “Sustainability by Design” reviews a renewed focus on how early integration of green practices into process development can optimize performance and long-term viability.

We also turn our attention to cleanroom practices, as “Evolving Cleanroom Procedures and Sterility Challenges” outlines how the rise of personalized and small-batch therapies is pushing the boundaries of existing protocols. In a world where every patient may receive a unique formulation, traditional sterility approaches must adapt.

Meanwhile, the future of pharma workforce development takes center stage in “Authentic Intelligence: Finding Diverse Talent in the AI Age.” The industry is at a crossroads—embracing AI while also addressing longstanding gaps in workforce diversity and retention.

Finally, our Ask the Expert column compares European vs. US GMPs, reinforcing the importance of navigating regional nuances even in an increasingly globalized landscape.

Collectively, this issue captures a pharmaceutical sector focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.

Mike Hennessy Jr is president and CEO of MJH Life Sciences®.

When referring to this article, please cite it as Hennessy, M. Quality, Resilience, and Reinvention in Pharma Manufacturing. 

The pharma industry is focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.

Quality, Resilience, and Reinvention in Pharma Manufacturing

Armin Spura, PhD, CEO of BioDuro, discusses what sets the company apart as a CRDMO

BioDuro is Redefining CRDMO Partnerships With End-to-End Innovation

Armin Spura, PhD, CEO of BioDuro, talks about the company’s evolution into a fully integrated contract, research, and development manufacturing organization (CRDMO), offering seamless services across discovery to development and commercialization. Spura discusses recent expansions in commercial-scale API production, peptide scale-up, and high-potency capabilities at the company’s Bengbu, China location. 

What differentiates BioDuro as a high-touch, high-quality CRDMO and how its integrated model streamlines drug development.

The company’s recent facility expansions in the U.S. and China in drug substance synthesis, peptide production, and more.

How BioDuro navigates geopolitical and regulatory landscapes while scaling global operations and client-specific solutions.

Videos

How BioDuro is expanding its global CRDMO footprint by improving integrated capabilities and delivering high-quality, end-to-end solutions for drug development and manufacturing

Q32 Bio, of Waltham, Mass., announced on April 30, 2025 that its human anti-IL-7Rα antibody, bempikibart (ADX-914), has been given fast track designation by FDA for the treatment of alopecia areata (AA) (1).

According to the National Alopecia Areata Foundation (NAAF), a California nonprofit, AA is a common, autoimmune skin disease characterized by hair loss, often in circular, coin-like patches, on the scalp as well as other areas of the face and body (“alopecia” means bald, and “areata” means patchy) (2). In severe cases, total hair loss is possible. NAAF said about 2% of the world population will experience AA, meaning approximately 700,000 people in the United States currently have AA in some form. More than 80% of those with the disease exhibit signs before age 40, with women more likely to develop it than men, and Asian, Black, and Hispanic populations having higher odds than whites.

As a fully human antibody, bempikibart re-regulates adaptive immune function, according to Q32 Bio, by blocking the IL-7 and TSLP pathways that have been genetically and biologically implicated as forces behind T cell-mediated pathological processes in various autoimmune diseases (1). Q32 Bio’s ADX-914 candidate, currently in development, is being evaluated in a Phase II trial.

FDA’s fast track process facilitates development and expedites review of new drugs that are intended to treat serious diseases and fill an unmet need, all with the goal of getting those drugs to patients faster (1). Drugs that receive a fast track designation may also be eligible for accelerated approval and priority review from FDA if certain criteria are met.

"The fast track designation granted by the FDA recognizes the seriousness of AA and the significant current unmet medical need while underscoring bempikibart's potential as a novel, differentiated therapy for patients needing new options," said Jodie Morrison, chief executive officer of Q32 Bio, in a company press release (1). "This fast track designation follows the encouraging clinical activity observed in Part A of our SIGNAL-AA clinical trial and the recent initiation of dosing in the Part A open-label extension and Part B portions of the SIGNAL-AA trial. We look forward to continued collaboration with the FDA as we work to deliver this potentially paradigm-shifting treatment to patients."

Alopecia areata was one of the diseases addressed at the March 2025 meeting of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use. At that time, 

an application for an initial marketing authorization

 was withdrawn for Cinainu (liquid ethanolic extract 30% [W/W] of Allium cepa fresh bulb and citrus limon fresh fruit/dry aqueous extract of paullinia cupana seed/dry hydroethanolic extract of theobroma cacao seed), an herbal medicine developed by Switzerland-based Legacy Healthcare for treatment of moderate-to-severe AA (3). No further details on the withdrawal were given, except for that Legacy took the action in February 2025 following a re-examination, according to EMA.

1. Q32 Bio. Q32 Bio Announces FDA Fast Track Designation Granted to Bempikibart (ADX-914) for the Treatment of Alopecia Areata. Press Release. April 30, 2025.
2. Alopecia Areata. National Alopecia Areata Foundation | NAAF. 

 (accessed April 30, 2025).
3. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 March 2025. Press Release. March 28, 2025.

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

FDA Grants Fast Track Designation to Q32 Bio Treatment for Alopecia Areata

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Alexander Seyf, CEO and Co-Founder of Autolomous

Political shifts in the United Kingdom and Europe may have a negative impact on research efforts for gene therapies performed by universities and other research organizations, says Alexander Seyf, CEO and co-founder of Autolomous. However, the impact on the bio/pharmaceutical industry is more likely to be minimal.

“The established companies in Europe, they still have a huge market in [the United States], and we've seen the growth and establishment of these companies expanding their operation to the United States and elsewhere in the world,” Seyf assures. “So, [because of the BIOSECURE Act], they might actually also consider [expanding] their activities in Asia. And the UK government gradually, but certainly, they [will] start also realizing they need to put more support through Catapult, cell and gene therapy, and other activities to boost the industry. [It] is a very ample opportunity for United Kingdom to put itself back in the map for cell and gene therapy and for new medicine.”

Click the video above to watch the full interview.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the impact geopolitical changes in Europe might have on the bio/pharmaceutical industry.

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