Chronic Disease Priorities, Biomarker Breakthroughs, and CGT-RLT Synergies

Behind the Headlines, Episode 22

ICH Q12 and Post-Approval Changes

The quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.

Advancements in Biopharma Spur Innovation

What Pharma Manufacturers Need to Know

Every Pharmaceutical Manufacturing Professional Should Know

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Protect environement | Image Credit: ©Y. L. Photographies -stock.adobe.com

Drug developers face increasing pressure to accelerate process development and reduce costs while ensuring safety and efficacy of investigational candidates and marketed products. They must achieve these goals while minimizing the impact that development and manufacturing operations have on the environment. Given shorter development times and the challenges associated with making process changes in later development stages, the best approach for improving sustainability is to incorporate sustainable practices into process designs as early as possible.

Considering sustainability from the outset

Sustainability-by-design in bioprocess development, according to Adam Goldstein, senior director of R&D Collaborations at Thermo Fisher Scientific, involves integrating sustainable practices and principles from the very beginning of the development process, which includes considering environmental impacts, resource efficiency, and waste reduction during the design phase, to create processes that are not only efficient but also lower the environmental footprint.

Because 80% of a drug’s final environmental impact is determined during the early stages of process design (1), Kami Krista, CEO of Elio Technologies, adds that sustainability needs to be part of the decision-making process during the early R&D and chemistry, manufacturing, and controls (CMC) phases—particularly before changes become difficult due to regulatory constraints (e.g., once process inputs are defined in the regulatory dossier).

In addition, because 42–47% of a pharmaceutical company’s emissions profile can be attributed to purchased goods and services (2), Krista emphasizes the importance of considering both process inputs and conditions. That means employing more environmentally friendly chemicals and processes.

Incorporating sustainability-by-design into process development activities is most effectively achieved by integrating sustainable practices throughout design, construction, and operation of biopharmaceutical production sites, according to Jacob Skou, sustainability manager at FUJIFILM Diosynth Biotechnologies. Key elements that are considered include resource and energy efficiency, waste minimization, and use of less hazardous chemicals and processes. “Processes are designed that optimize the use of raw materials, energy, and water, and alternative renewable energy options such as solar and wind are used where possible to increase energy efficiency. Furthermore, strategies are implemented for reducing, reusing, and recycling waste material generated during bioprocessing,” he says.

Krista concludes that “to successfully integrate sustainability, it is essential that every scientist, process engineer, and other relevant stakeholders can easily assess the sustainability implications of their decisions—alongside technical and cost considerations—and weigh the associated trade-offs.”

Environmental, operational, and cost benefits

Adopting a sustainability-by-design approach in biopharmaceutical manufacturing offers a wide range of benefits in addition to reducing the impact of development and manufacturing operations on the environment. Skou highlights cost efficiency, compliance and risk management, innovation, and increased social responsibility as important benefits resulting from the integration of sustainability into bioprocess development activities.

“Reducing resource and energy consumption and minimizing waste reduction benefits the environment and contributes to cost reductions. Furthermore, as environmental standards become more stringent, adopting sustainable practices helps ensure continued compliance and reduces the risk of legal penalties and reputational damage. Taking a sustainability-by-design approach can also drive innovation that results in market-differentiating processes. Finally, sustainable practices emphasize ethical considerations; promote the health, safety, and well-being of employees and communities; and thus align with broader social responsibility goals,” Skou explains.

Goldstein emphasizes the importance of the innovations that result from adopting a sustainability-by-design approach because they can lead to improved product quality and process efficiency.“Driving higher titer in smaller volumes means yielding higher throughput of product in a smaller footprint. The benefits are lower cost of goods in manufacturing while simultaneously delivering the product in a much more sustainable fashion with regards to emissions reductions,” he comments.

Another important benefit of taking a sustainability-by-design approach for Krista is the fact that by integrating sustainability improvements from the outset, it is not only possible to dramatically reduce the impact of biopharmaceutical operations and the overall environmental footprint of the product and company, the high costs and challenges to making sustainability improvements during later stages are avoided.

There are marketing advantages as well. For contract development and manufacturing organizations (CDMOs), Skou believes having an improved sustainability profile is a competitive advantage.

Krista also notes that in Europe, many hospital procurement systems (i.e., England’s National Health Service and the Joint Nordic Procurement system) are including sustainability performance as a decision criterion when selecting drug products. For public companies and early-stage firms seeking specific investors, having a good sustainability rating (often based on product stewardship, sustainable raw material selection, or similar ecodesign criteria) can attract more investors. Sustainability is also increasingly featured as a decision criterion by Big Pharma companies when making merger and acquisition decisions, according to Krista.

All aspects of biopharmaceutical manufacturing should be considered when taking a sustainability-by-design approach to bioprocess development, starting with the choice of cell line through methods for waste processing, according to Goldstein.

“High-titer cell lines are more productive, while chemically defined media reduce contamination risks and allow for sourcing of materials from sustainability-minded suppliers. Using centrifugation rather than depth filtration can reduce waste and processing times while improving yields, and higher-capacity chromatography resins can reduce buffer usage,” explains Goldstein.

Intensified processing both upstream and downstream can, meanwhile, reduce manufacturing footprints and resource consumption while reducing waste generation and improving facility throughput.

Upstream intensification examples highlighted by Goldstein include the use of high-density cell banking to skip long drawn-out seed expansions (reducing the six to eight days of standard good manufacturing practice [GMP] expansion) saving time, money, and resources (plastic, water, and media) by employing the use of single-use bioreactors (SUBs) that have high turndown ratios, which allows seeding at very low operating values and the growth of cells to high densities as the volume is expanded in the same unit operation SUB step. Downstream opportunities include the use of membrane separations.These technologies replace larger chromatography columns that use large volumes of buffers and take entire shifts to run.

Real-time monitoring of processes via inline sampling, often an important component of process intensification and continuous processing, also helps ensure more robust and high-quality processes and products, according to Goldstein. “Additional efficiencies are gained using ballroom designs vs. traditional costly, broken-up manufacturing suites, allowing for greater use and flexibility of manufacturing space, while funneling of waste into circular waste streams via collaborations with waste-stream recyclers add further benefits,” he notes.

The choice of water purity for certain activities can also have a significant sustainability impact. Highly purified water (like water for injection) is extremely costly and resource laden from a carbon footprint perspective, due to the vast number of steps (steam evaporation, filtration, heating, cooling) that are involved in its creation per liter, Goldstein explains. Specifying a lower quality of purified water (like reverse osmosis quality water Type 2 vs. Type 1) can and should be considered in the makeup of media, cleaning of equipment, and the creation of general early-stage purification buffers (until the process is in the final formulation stage). “Careful consideration and selection of the standard of water used for many manufacturing operations can drive large impactful improvements,” he states.

Collaborating across the entire supply chain is, in fact, an essential component of a sustainability-by-design approach to bioprocess development, according to Ann-Cathrine Rosendahl, global sustainability manager with FUJIFILM Diosynth Biotechnologies. “When we talk about sustainability-by-design in bioprocess development, it’s not just about what happens on the factory floor—it’s about embedding sustainability into every step of the journey, from raw materials to the end-of-life of a product, to build a more resilient and responsible supply chain,” she notes.

Given that a significant part of bioprocess emissions comes from upstream activities (92%), engaging suppliers early is essential, Rosendahl says. “The sustainability of suppliers should be evaluated early, and we are working towards ensuring that partners who prioritize environmentally friendly practices—such as responsible sourcing and transport—are prioritized in our selection process,” she states. FUJIFILM Diosynth Biotechnologies is also committed to reducing environmental impact by working closely with suppliers to improve energy efficiency, adopt cleaner technologies, and explore innovative solutions that lower emissions. “By integrating sustainability into our business reviews and setting clear expectations, we are building stronger partnerships focused on continuous improvement,” Rosendahl remarks.

Sustainability aspects for final product management must also be considered. Where possible, packaging and logistics should also be optimized to reduce waste and emissions, according to Rosendahl. Promoting transparency and accountability is equally important to her, which she observes can be achieved by developing metrics for assessing sustainability performance and reporting progress to stakeholders. That, Rosendahl underscores, requires access to accurate data to ensure a clearer understanding of the Scope 3 footprint for biopharmaceutical manufacturers (indirect greenhouse gas emissions generated outside the company across its value chain).

“Having better data helps companies identify where the biggest impacts are and explore opportunities with suppliers to make processes more sustainable over time,” Rosendahl adds. “By addressing these aspects, companies can move toward an approach to sustainability that considers not just the products themselves but also the surrounding processes, infrastructure, and practices, leading to a holistic and effective sustainability strategy,” she concludes.

As an example, Goldstein highlights a program his company has established to connect customers with recyclers that can recycle single-use bioprocess containers (BPCs) after use. “This program helps biopharma manufacturers divert waste from landfills or carbon-intensive incineration, advancing their sustainability goals through a convenient recycling service that turns BPCs into high-quality plastic lumber. Approximately 400,000 pounds of plastic waste has been diverted from landfills or incineration since initiation of the program,” he observes.

Work is now focused, Goldstein says, on identifying recyclers that can accept mixed waste from biomanufacturers and convert those materials to bio-oil, which can then be recycled into new polymers. These new polymers can be used either in the biomanufacturing environment or in entirely separate recycled products, such as faux wood, fillers for roads, etc.

The key to successful pursuit of a sustainability-by-design approach to bioprocess development is effective assessment of the environmental impacts of each unit operation. The first step, emphasizes Krista, is to equip scientists, process engineers, and all others involved in process development with tools that allow them to understand the sustainability impact of the decisions they are making.

Those tools must then be employed to thoroughly assess process development activities and identify opportunities for incorporating more sustainable practices, adds Goldstein.

Growing adoption, but several hurdles to overcome

The adoption of sustainability-by-design is growing, driven by regulatory pressures, consumer demand for greener products, and corporate environmental sustainability goals, according to Goldstein.

As environmental responsibility continues to become a major focus, the bioprocessing industry is transforming its approach to sustainability, with a major driver being requests from customers and investors to deliver on this agenda, evidence that strong sustainability strategy and actions is good business, adds Peter Skals, director of global sustainability for FUJIFILM Diosynth Biotechnologies.

In fact, based on 2024 data, nine of the top 10 pharma companies by revenue have ecodesign targets and activities embedded into their sustainability strategies, Krista observes. “The breadth of these ecodesign targets and activities vary from specific targets like green chemistry to programs that cover the entire value chain. In addition, while Big Pharma companies are leading the charge on ecodesign, due to pressures from customers, investors, and regulators, biopharma service providers, small and emerging biotechs, and suppliers are all stepping up activities focused on improving sustainability,” he comments.

Reaching aggressive sustainability targets requires overcoming some notable challenges, however. For instance, broader application in the bioprocessing sector is inhibited by inherent limitations of the bioprocess itself, which requires a different approach due to quality and safety restrictions, according to Skals. In addition, Goldstein notes that designing in sustainability for process development must begin in the pre-clinical phase, with the capability of selected raw materials demonstrated via qualification early in the development stage.

Sustainability also needs to be integrated into pretty much every design decision, leading to a very high volume of decisions that it must be seamlessly embedded into, Krista says. In addition, he notes there are inherent trade-offs to be made, with each right decision context-dependent, increasing the complexity of the decision-making process because more parameters must be considered.

Other important challenges noted by Krista include the lack of available “clean” data for performing sustainability assessments and the time- and cost-intensive nature of current assessment methods. “A lot of the data that [are] required to assess the sustainability impact of process design and process input selection [do] not exist or [are] hard to get,” he says. Much is based on responses to supplier surveys, which are not in sufficient quantity to support effective decision-making. Traditional lifecycle assessments, meanwhile, require weeks to months to complete, and can cost in the hundreds of millions for typical processes if you include the assessments for each of the different process-design and process-input variations at the relevant decision points (3).

Further increasing the challenge is the fact that most technical staff in bioprocessing plants are not sustainability experts. “Upskilling people in sustainability to the level that would be necessary to complete sustainability assessments is not feasible, which means straightforward guidance is needed,” Krista says.

Finally, Krista emphasizes the importance of not only quantifying and naming the sustainability pressures driving ecodesign today, but assessing those that will be present 10 years from today when investigational candidates eventually reach the market. “The most sophisticated pharma companies in the context of ecodesign are considering this impact lag and extrapolating in order to assess sustainability pressures beyond the response of a particular political party in power today, but where the longer arc of history is bending towards,” he contends.

Despite all these challenges and uncertainties, Skals believes that industry innovations and the inclusion of sustainability practices in the design phase is where the big wins can be achieved. But the incremental improvements of traditional designed bioprocess are important as well, he adds, and reduce waste without compromising product quality, stability, or safety.

Advances in digital technologies are making those assessments easier to perform and providing more valuable insights. Advanced technology facilitates access to reliable process monitoring data, allowing identification and prioritization of potential areas of improvement and implementation of appropriate process adjustments, according to Skals.

Technologies such as automation, real-time monitoring, and advanced analytics help in achieving precision and efficiency, adds Goldstein. He comments that innovations in materials science also contribute to more sustainable bioprocesses.

Machine learning (ML) can help overcome many of the challenges that exist in applying sustainability-by-design today, Krista contends. “At Elio, we believe ML is critical to ensuring sustainability-by-design can be adopted as widely as possible, as early as possible, and thereby have the biggest impact. Specifically, it can help with the challenge of insufficient, high-quality data,” he says.

ML models, Krista explains, in combination with data engineering, can help fill in data gaps with sophisticated estimations using data about the specific product, supplier, and/or specific process aspects from a wide variety of data sources that are available publicly (freely or through a license). “Using this approach can enable bypassing of the data bottleneck coming from relying on supplier surveys,” he adds.

“Pharma companies are already making decisions based on very crude generalizations, such as based on product category (e.g., all alcohols have the same footprint) or other characteristics (e.g., a chemical with a higher molecular complexity has a higher environmental footprint),” Krista observes. “ML models can simply be trained on a much higher dimensionality of data and thus can make higher accuracy predictions,” he contends. Using ML tools thus also addresses the time and cost issues associated with sustainability assessments, as the calculations can be completed much more quickly and at scale.

The biopharmaceutical industry does not typically have a first-mover mentality due to stringent regulatory requirements and the need to ensure patient safety. However, Skals believes there is potential for even more intelligent sustainability solutions in the future, particularly through incorporation of improvements in greenfield designs.

It will be necessary, though, Krista emphasizes, to move away from a desire to wait to get enough of the “best” data, which pharma professionals Elio Technologies has spoken to estimate will not be available for another 5–10 years. “Fortunately, sustainability leaders in pharma companies and even pharma suppliers are recognizing that making decisions based on imperfect data earlier is key,” he comments (4,5).

Most importantly for Goldstein is the fact that sustainability-by-design is not merely a passing trend but a fundamental shift in how bioprocesses are conceptualized, developed, and ultimately transferred to commercial operations. “Goals are defined not just in yield and cost, but also by sustainability in delivering a socially responsible product. Collaborative efforts across the supply chain are underway, with companies across the industry committed to driving continuous improvement in sustainability performance,” he asserts. “Ultimately, driving sustainability into the design of our process development strategies ensures that we continue to innovate in a responsible manner while delivering high quality products for our customers,” Goldstein concludes.

Barle, E.; Melton, T.; Judge, E. Sustainability by Design for Pharmaceutical Products. Pharm. Engin. 2023 March/April.

Elio Technologies. Analysis using data from: My Green Lab, The Carbon Impact of Biotech & Pharma. November 2022.

Elio Technologies. Interviews with pharma companies and internal Elio Technologies research and analysis.

Cytiva. 2024 Global Biopharma Sustainability Review.

D’Souza, N. and Fava, J. Episode 13: Merck’s Jeffrey Whitford on Why Optimisim is Opportuity and How to Use Serendipity to Become Systematic. Five Lifes to Fifty. Podcast. Nov. 21, 2024.

Cynthia A. Challener, PhD, is a contributing editor to 

When referring to this article, please cite it as Challener, C.A. Sustainability by Design in the Context of Bioprocess Development. 

Articles

Incorporating sustainable practices into process designs as early as possible ensures optimal performance.

Sustainability by Design in the Context of Bioprocess Development

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. 

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.”

Doing the best to keep a step ahead of the latest AI innovations 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 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, 

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.

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.

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