By Cynthia A. Challener
Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.
Significant growth in the development and manufacturing of biologics—from traditional recombinant proteins and monoclonal antibodies (mAbs) to advanced multispecifics, antibody-drug conjugates, viral oncolytics, and cell, gene, and gene-editing therapies—was occurring worldwide before the emergence of the COVID-19 pandemic. Demand for biosimilars is also increasing. The requirements associated with COVID-19 vaccine manufacturing are placing further pressure on upstream manufacturing capacities.
“The situation is evolving as the industry continues to explore the right balance between internal capacity/capability and external capacity/capability and key strategic partnerships,” says Lynn Bottone, vice-president of Pfizer Biotech Operations. “Generally, the industry doesn’t have idle capacity across key technologies to bring on line with immediate effect. The challenges of the last year have made the industry revisit and reconsider these options with a rethinking of certain approaches,” she adds. That includes the supply of key inputs to upstream processes as well.
As a result, a strong and sustainable supply network is more vital to ensure supply chain stability, according to Youngsun Kim, director of the manufacturing science and technology team at Samsung Biologics. “Global sourcing of raw materials is an integral part of the supply chain, but recent events have highlighted that relying only on a single source can increase risk during a crisis. Many companies are looking to diversify their supply chains to reduce the risk of disruption in the future,” he says.
Equipment suppliers, contract manufacturers, and biopharmaceutical companies are implementing new bioprocessing solutions and manufacturing strategies to increase efficiency and productivity, forging innovative partnerships, and investing in additional physical capacity on a global basis.
Evolution in bioprocessing
The increasing diversity of advanced therapies has driven upstream manufacturing processes to evolve, according to Philip Vanek, CTO at Gamma Biosciences. “The latest iteration of technologies is being developed with scalability, process intensification, and lean principles in mind to ensure quality and reliability for the life of a process,” he asserts.
Process flexibility and technical innovations are key strategies to accelerate the pace of process development while increasing upstream capacity, adds Dirk Lange, CEO of Selexis and president and CEO of KBI Biopharma. “Accelerating processes means going into manufacturing faster, and with that there can be bottlenecks. CDMOs [contract development and manufacturing organizations] must provide flexibility to address bottlenecks, like taking the most streamlined path possible, decoupling upstream and downstream processes, and managing technical risks more effectively (i.e., using new technologies that help create flexibility),” he explains.
Developing and scaling up manufacturing operations and analytical testing capabilities are, however, requiring major innovation and the courage to move away from conventional constructs, asserts Bottone. “The paradigm shift only occurs with reimagining the way we’ve worked previously, and this reimagining is required at all functional nodes of the product lifecycle and through the end-to-end supply chain. A focus on our horizontal integration internally and externally has been a key enabler for the COVID-19 vaccine and will be key to future new product introductions,” she notes.
The upstream capacity landscape does, however, vary largely with the product class, process design, and technology selection, notes Tania Pereira Chilima, deputy CTO of Univercells Technologies. She points to the mAb sector where stainless-steel bioreactors with tens of thousands of liters of capacity were commonly used for cell culture, but today have been replaced with single-use (SU) bioreactors with thousands of liters of capacity due to significant increases in upstream productivity. The use of perfusion processes has enabled even larger throughputs within the same bioreactor volume.
Furthermore, Chilima observes that by using scalable technologies that have representative scale-down models early in the process development, companies are able to evaluate the capacity needed early on and plan accordingly. Innovation in process analytical technologies (PAT) is similarly driven by the need to boost both the productivity and therapeutic value of each bioprocess, according to Vanek.
Shortening development timelines has been another focus of the industry. “Efforts have targeted the development of new expression technologies, parallel tracking of activities that are not on the critical path, and implementing high-throughput, small-scale technologies,” comments Atul Mohindra, senior director for research and development with Lonza. This work, he adds, has resulted in a significant reduction in process development timelines and is therefore having a positive impact on upstream capacity.
Digital transformation also affords good opportunities to improve lead times for rapid cycle process development, upstream capacity availability, and quality, according to Kim. Samsung, for example, is leveraging automation, ultra scale-down modeling in microreactors, in-silico and predictive modeling including metabolomics, and mobile apps for company-wide data visibility to reduce the client tech-transfer process to as little as three and one-half months while maintaining high levels of quality.
Viral vectors are a special case
Viral vectors, which are used directly in therapeutics and vaccines and also in the production of gene and gene-modified cell therapies, represent a special case with respect to manufacturing capacity shortages.
Traditionally, viral vectors were manufacturing using plasticware such as roller bottles and T-flasks and manually-intensive processes that required scale out rather than scale up to increase capacity, leading to severe constraints, according to Chilima. “These challenges can be overcome through the use of scalable technologies such as stirred-tank bioreactors or even intensified, scalable technologies such as fixed-bed bioreactors,” she says.
Upstream capacity in viral-vector manufacturing is also impacted by capacity limitations in downstream processing. This issue is currently leading many CDMOs to reject projects or set long wait times for new customers to ensure they are able to fulfill their existing contracts, even though they may have under-utilized upstream capacity, says Kai Lipinski, chief scientific officer at Vibalogics.
On a positive note, parallelization of experiments using automated systems for high-producer clone selection, along with medium optimization and the availability of standard kits, are having an overwhelmingly positive impact on capacity, according to Lipinski. The implementation of platform processes that require no or minimal development (e.g., a single cell line is used for many products along with a platform production medium and optimized vector platform design) is also saving time and cost. Similarly, accurate scale-down models and the use of a quality-by-design approach during development are minimizing risk and providing increased predictability when moving to large-scale production
The one factor currently limiting the pace of change, Lipinski asserts, is talent availability. “More expertise is needed across the industry to help companies identify new ways to further improve process development to make better use of existing upstream capacity,” he states.
Impact of COVID-19
The COVID-19 pandemic has created greater interest and awareness in the biotech sector, which seems to be leading to more investment and greater utilization of current biologics manufacturing capacity, says Jeetendra Vaghjiani, director of commercial mammalian development at Lonza. Overall, though, he notes that COVID-19-related projects including vaccines are using up capacity that may have been used for other therapeutic products, which has increased the demand for upstream capacity.
Tony Hitchcock, technical director for Cobra Biologics, disagrees. “The production of COVID-19 vaccines and therapies is largely disconnected from traditional biologics as the first authorized candidates are based on adenoviral technology (AstraZeneca/Oxford and Janssen) or messenger RNA (mRNA) (Pfizer-BioNTech, Moderna), with candidates still in development being DNA-based (Scancell), protein-based (Novavax), and using more classical technology (Valneva). This manufacturing is performed outside of mainstream biopharma, where most capacities and capabilities involve the production of mAbs,” he explains.
While Lange says that COVID-19 has created a temporary shortage of upstream capacity for a portion of the industry, this spike has been counteracted by a stronger focus on life sciences as a whole, with more funds being pushed into biotech for other vaccines and therapeutics. “Large capital investments will provide relief and support growth of the industry in the mid-term,” he remarks.
Biopharmaceutical companies of all sizes have sought additional contract manufacturing capacity to free internal capacity, expedite process development and large-scale manufacture, and forge partnerships to secure secondary sources in their drug supply chains, according to Kim. “Having a stable secondary source plays an essential role when it comes to supply continuity, especially during times of uncertainty like COVID-19,” he states.
For instance, Regeneron has been working with FDA and the US government to rapidly scale up production of its REGEN-COV antibody cocktail. The company is leveraging production and manufacturing platforms developed over decades, financial support from BARDA, and accelerated licensing of its Irish facility.
“This approach has enabled us to adjust much of our internal manufacturing activities to maximize our ability to produce REGEN-COV while still ensuring patients get the other FDA-approved Regeneron medicines that they need,” says Hannah Kwagh, senior manager of corporate communications at Regeneron. The full portfolio of commercial products can be manufactured in Ireland, enabling the company’s US site to maximize production of REGEN-COV.
“Right now, under our agreement with the US government, we expect to deliver approximately 750,000 doses by June 30, 2021, with the vast majority of these deliveries occurring in the second quarter. We are evaluating a lower dose (1.2 gram) for REGEN-COV and should this lower treatment dose receive Emergency Use Authorization or approval from the FDA, we aim to deliver up to 1.25 million doses by June 30, which is the maximum quantity that is authorized for purchase by the US government under this supply agreement,” Kwagh says.
To support its COVID-19 vaccine (BNT162b2), Pfizer had to both expand its capability and build new capacity for the upstream process, which it did in part through various partnerships. “Industry collaboration is evident in numerous examples where companies have supported one another to get a vaccine or a therapeutic to patients faster. The industry has been pretty courageous not only in expanding or building capacity without knowing whether the platform/product would be successful, but also in extending unutilized or underutilized capacity to competitors for the common good,” states Bottone.
There have, however, been supply chain challenges attributed to the COVID-19 pandemic. “Vendors have rapidly shifted focus to produce materials to support COVID-19 vaccines and therapies, and as a result some therapeutic developers have had to slow down or redirect demand for equipment, reagents, and consumables,” says Vanek.
In general, adds Christian Morello, head of global supply-chain planning and programs management at Lonza, the demand for materials used for the manufacture of biological products has increased over the past five years, and mainly for SU equipment, and the accelerated development and production of COVID-19 vaccines has increased the demand much faster than suppliers have been able to increase capacity.
“The upstream processing industry, especially in the SU space, was already experiencing significant demand and growth pre-COVID-19. With the rapid development of new COVID-19 vaccines and therapeutics, incremental capacity for both hardware and consumables is coming on line at a record pace. That said, there are challenges within the supply chain as the industry addresses shortages in raw material and component availability, affecting overall lead times in many areas,” agrees Jon Van Pelt, general manager of Cytiva’s bioprocess, single-use, and enterprise solutions business. He anticipates continued supply constraints in certain areas for the next several quarters as new capacity comes on line.
“The constrained supply chain for such materials is creating the need for daily management and frequent reshaping of production plans, while also accelerating the validation of dual sourcing to decrease exposure to such risk,” Morello observes.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak has highlighted the need for high-capacity, scalable technologies for viral vaccine production, adds Chilima. “This outbreak has shown that using manual technologies is not a suitable strategy when large quantities of doses are required during a pandemic. Many companies using adherent cells have been driven to consider more scalable technologies that maintain a similar microenvironment for the cells,” she notes.
On the positive side, Hitchcock notes that the COVID-19 pandemic is not only stimulating new investments from the private sector and strategic investments from governments to establish local vaccine production capabilities, but also accelerating the development of these technology platforms and their broader application beyond cancer indications.
Contract manufacturers, drug developers both affected
Both biopharmaceutical companies and their outsourcing partners have both been impacted by the increased demand for upstream bioprocessing capacity. “This increased demand impacts equally classical pharmaceutical capacity and CDMO capacity as it is the product that is important,” Morello says. “In that perspective,” he adds, “it was interesting to see the collaborative approach on the supply chain between sponsors and CDMOs.”
KBI Biopharma has observed that clients focused on COVID-19 vaccines have limited in-house capacity. As a result, many are moving other vaccine products with shorter timelines to CDMOs, leading to the increased demand across the industry as all manufacturers adapt to the manufacturing challenges created by the pandemic while still maintaining production of other vaccines and therapeutics.
Vaccine manufacturing in terms of capacity, according to Hitchcock, has largely been provided by CDMOs operating in the cell and gene therapy space for viral vector and plasmid DNA production. “Prior to the pandemic, large investments in capacity were being put in place with the likes of Cobra Biologics in the UK completing its viral vector production expansion in 2020 and with other significant expansions being carried out globally to keep up with the growth of the advance therapies sector. This activity was certainly serendipitous,” he comments.
Lipinski believes, however, that CDMOs are likely to be more impacted than biopharma companies by upstream capacity issues because they cannot easily divert capacity committed to existing customer projects to COVID-related projects without authorization from those customers. “Drug developers, on the other hand, have greater freedom to define and change their development priorities, allowing them to refocus capacity on the fight against the pandemic,” he remarks.
That is at least true for large biopharmaceutical companies, but small and emerging biotech companies typically rely on the manufacturing capacity, expertise, and flexibility of CDMOs to bring their candidates to market. “With most of the drug development pipeline being held by these emerging and small biotechs, CDMO bioprocessing capacity is gaining importance,” Vaghjiani states.
Despite the challenges, Lipinski does stress that CDMOs have quickly responded to support customers seeking to deliver new COVID vaccines and therapies.
Noticeable shifts in manufacturing strategies
While the addition of more upstream capacity has been occurring and continues to take place, CDMOs and biopharmaceutical companies are also investing in new technologies and manufacturing strategies to achieve capacity increases.
“There is drastic disruption needed to support the commercialization of advanced therapies,” Vanek asserts. He points to three emerging themes that are dramatically improving manufacturing efficiency across the biologics spectrum and thus ultimately impacting upstream bioprocessing capacity: continuous manufacturing, process analytics, and radically improved downstream purification. “There is a real shift,” agrees Chilima, “towards intensified technologies that enable dramatic reductions in operational footprints and increased overall productivity.”
There is also a lot of focus on compressing the biologic drug development timeline within the industry, especially in the process-development space, according to Van Pelt. “If you think broadly, from process development to clinical to CGMP [current good manufacturing practice] production, advances in digital solutions are accelerating the pace of drug development. Validated platform processes, modeling, connectivity, PAT, and other digital tools will allow for increased speed and process understanding while reducing the risk of failure as the process advances through the various development stages,” he observes.
Selexis and KBI Biopharma, for instance, have invested in technology and innovation in cell-line development and process development to reduce cost of goods while increasing output at a given scale. High-yielding cell lines and process intensification are powerful strategies to address growing demand, according to Lange. The company has also invested in digitalization and manufacturing 4.0 technologies to maximize the effectiveness of its operations.
Lonza, too, has invested in technologies and processes to reduce development, tech-transfer, and batch-release timelines for increased throughput and therefore additional capacity, according to Mohindra. “In addition, we are further improving right-first-time success rates and our lean management systems and have implemented in-line testing technologies that leverage digitalization to increase productivity,” he says.
Pfizer has leveraged production systems and its management infrastructure to free up time for continuous improvement of operations and innovation, according to Bottone. “Expanding our digital capabilities has been important in the pursuit of big data analytics that has enabled efficient and effective development, analysis, and review of significant quantities of data. Automation of historically manual processes has been equally impactful,” she notes.
Development of rapid analytical methods; the use of robust inline, online, and at-line monitoring and testing capabilities to reduce the reliance on end-product testing, exploration of accelerated regulatory pathways to approval for emerging technologies, application of the use of digital twins to increase operational efficiencies, and the application of artificial intelligence to historically manual processes like automated visual inspection are all taking place at Pfizer.
Innovation in storage and distribution was evident with the mRNA vaccine roll-out, Bottone adds. “Modular and mobile solutions will be important for scale-up and capacity-expansion opportunities with much shorter lead times,” she observes.
SU technologies are also being widely implemented for commercial as well as clinical production to minimize the time and costs associated with maintenance and cleaning of standard reusable equipment, according to Lipinski. SU bioreactors are now available up to 5000 L, enabling larger batch sizes. Companies are also leveraging high-cell-density perfusion processes to boost efficiency, according to Lipinski.
Increased focus on alternate sourcing for both materials and intermediates and use of automation, production scheduling, and batch release are becoming more prominent, comments Kim. “The supply of raw materials and consumables is critical to ensuring the timeline for large-scale production, especially at the moment. What we’re seeing across the board is sponsors providing alternative (secondary and tertiary) vendors for key raw materials and CDMOs taking responsibility for establishing an alternative consumable inventory list for faster procurement, especially for the commonly used consumables in the biopharma industry,” he observes.
Means for enhancing viral-vector productivities are also being explored, such as screening for high-producer cell clones, using technologies to achieve high cell densities and perfusion cultures, and optimizing virus recovery. In addition, Lipinski notes that the use of high-efficacy viral vector platforms to minimize the needed vaccination dose can play an important role in helping to make better use of existing capacity.
On the front end, the use of prefabricated container-like clean rooms in new facilities is accelerating timelines for the completion of capacity expansions, according to Lipinski.
Numerous investments to expand capacity
Both CDMOs and biopharmaceutical companies are investing heavily in long-term capacity, with individual investments too numerous to list. KBI Biopharma, for instance, is implementing a global expansion strategy that includes bringing online new clinical and commercial manufacturing facilities in the United States and Europe.Vibalogics is in the middle of a $150-million investment at its site in Boxborough, MA, and is currently also investing extensively in its early-phase facility in Cuxhaven, Germany.
Samsung implemented large-scale N-1 perfusion to enable inoculation of production bioreactors (15,000 L) at higher cell densities and achieve peak cell densities within shorter culture durations. The company has also invested in process automation, including a manufacturing execution system, and online monitoring capability and is looking to fully automate its activities. A new manufacturing facility is also under construction and expected to be operational by the end of 2023. “The newly built plant, which will be the world’s biopharmaceutical manufacturing facility, will be fully equipped with multi-scale bioreactors and advanced technology to meet the trending needs of the market and clients,” Kim says.
Significant activity has occurred in the plasmid DNA and viral vector space. Cobra Biologics, which was acquired by Cognate Bioservices in 2020 and is soon to be acquired by Charles River Laboratories for $875 million (1), is quadrupling its clinical and commercial capacity for high-quality DNA manufacturing in Europe and doubling its capacity in the US. Some other companies that have recently completed or announced new capacity include Matica Biotechnology, Porton Biologics, Fujifilm Diosynth Biotechnologies, Oxford Biomedica, Emergent BioSolutions, BioReliance (Merck KgaA), WuXI Advanced Therapies, Delphi Genetics, Biomay, VGXI, and Thermo Fisher Scientific.
SU equipment suppliers have also responded to the need to increase output and reduce lead times for disposable biopharmaceutical manufacturing solutions. Pall Corporation, for instance, is expanding capacity at six existing manufacturing sites in Europe and the US and constructing a new manufacturing facility in the US (2).
Partnerships have a role to play
The need for access to greater upstream (and downstream) bioprocessing capacity has led to the formation of interesting partnerships across the industry. “The current crisis has triggered a need for companies to collaborate even more closely and think out of the box to address issues beyond company boundaries or legal entities. This virus doesn’t respect corporate or geopolitical boundaries, so the industry has had to respond accordingly,” Lange says.
Because adding new capacity can take time, the current need for immediate capacity is leading companies to find innovative ways to meet capacity demands, adds Vaghjiani. Partnerships and collaborations are an important strategy for expediting capacity expansion plans to ensure there is enough upstream bioprocess capacity to manufacture the vaccines and therapeutics needed to address the COVID-19 pandemic, agrees Oliver Loeillot, vice-president of Cytiva’s bioprocess business. “Depending on the needs of each organization, partnerships and collaborations will remain a strategy for capacity expansion for the foreseeable future,” he says.
“Partnerships between biopharma companies will provide flexible and agile supply options driven by demand and capacity,” asserts Kim. “Increased partnerships across all supply chain segments will de-risk supply and the overall required investment and give access to flexible manufacturing capacity supported by innovative technologies and facilities, extremely well-trained staff, and competitive pricing,” he continues.
Numerous industry collaborations, including strategic partnerships between companies and contract service providers exploring ideas around flexible capacity and partnerships with vendors and suppliers to better understand and solve their capacity challenges, are playing a role alongside significant capital investments in capacity and capability and a paradigm shift in reducing capital project timelines to support capacity expansion, Bottone adds.
For Lipinski, such partnerships are crucial to increasing production scales within a reasonable time frame and to addressing upstream biopharma capacity needs in the future. “Small and newly-established biotech companies often have little to no drug development or regulatory experience, meaning they need supportive partners with the knowledge and capability to bring their innovations to market. The same is true for supply-chain management of drugs,” he says.
Large pharmaceutical companies, with their well-established experience in biopharma development and regulatory insight, can help these smaller partners, Lipinski observes. “They can play a key role in supporting and minimizing development timelines for Phase I/II/III all the way through to commercial.” He also notes that CDMOs are also well placed to provide this support, delivering infrastructure and regulatory expertise to address gaps in small biotech companies’ knowledge.
Manufacturers will also need to work very closely with vendor partners to project longer-term supply needs and evaluate new alternatives for materials that are most impacted by the vaccine manufacturing demand, says Lange.
For Regeneron, innovative partnerships have been key to ensuring that the company is getting medicines and vaccines to patients as efficiently as possible, according to Kwagh. For example, she notes that while Regeneron currently anticipates that the full supply of REGEN-COV for its agreement with the US government will be produced by Regeneron, the company has also significantly increased global capacity through a collaboration with Roche. “Collectively, we now expect to be able to produce more than 2 million treatment doses per year, and if data supports use of a lower dose of the cocktail this figure would increase accordingly,” she says.
“The whole life sciences industry is coming together to address this global crisis and moving forward, we hope this will inspire collaboration to achieve the common goal we share—delivering life-saving treatments faster than ever to the patients who need them most—every day, not just during a crisis,” concludes Lange.
Preparing for the future
Addressing bioprocess capacity issues is essential to the future success of many biopharmaceutical products. Regeneron’s ability to provide high numbers of finished doses of REGEN-COV is predicated on continued success in the manufacture of bulk product and access to third-party fill/finish capacity, which is under heavy demand from COVID-19 vaccine manufacturers, is just one example. “Looking ahead, as an industry we need investment in both R&D technology and manufacturing infrastructure in order to better prepare for future pandemics,” Kwagh says.
The innovative collaborations/relationships that have been established during the pandemic should continue to be explored as key strategic levers, notes Bottone. “The idea of flexible capacity that can be brought on line with immediate effect is an interesting and appealing proposition when you consider our collective experiences of the last year with the pandemic,” she says. In addition, Bottone suggests that collaboration between clinicians, regulators, and industry will determine how much acceleration of drug development and commercialization is possible, and the signs are encouraging.
The COVID-19 pandemic, according to Lange, is a case study in what happens if global capacity models are unexpectedly disrupted. Fortunately, many innovative technologies are being developed with the potential to enhance and shape the future of biomanufacturing, Vanek observes. “The challenge lies in scaling these technologies in ways that will unleash productivity and spur further innovation,” he states.
Across the industry, though, Vanek believes there has been a gap in investment capital for companies that have launched these innovative products but still require guidance to fully scale and industrialize their solutions. “Without expert guidance and proper representation. these innovations could be lost or stifled if they are acquired or merged into large life sciences companies with many competing priorities,” he says.
The supply of crucial SU upstream process equipment and consumables is a key concern for Lipinski, with delivery times of up to 52 weeks currently expected across the industry. He also notes that aseptic filling of biologics, in particular live virus filling, is one of the most critical bottlenecks in the biopharma development and manufacturing process, including availability of the required primary packaging material. This bottleneck ultimately impacts upstream capacity too.
“Steps need to be taken to address these issues as quickly as possible in order to optimize biologics manufacturing capacity,” Lipinski says. He adds that the development of a form of generic consumable equipment and packaging in the near future may help to overcome the overall shortages of key materials, allowing the increased production of viral vector and virotherapy products using SU production systems.
In the meantime, companies developing new biologics, and in particular vaccines, oncolytic viruses, and gene therapies based on viral vectors, need to identify and access manufacturing capacity as early as possible to ensure they can bring their innovations to market as soon as they receive regulatory approval, according to Lipinski. “Waiting for limited capacity to become available is not practical, and the earlier they engage with a potential manufacturing partner, the more control they will have over their timelines and speed to trial,” he asserts.
Access to talent is another issue that must be addressed to ensure future success in biomanufacturing. “Every fast-growing company has experienced the limiting effects of a defined talent pool and an overall shortage of qualified personnel. Capital investments, engineering projects and process improvement are fundamental to enable the projected growth of our industry, but we also need to work on a sustainable pipeline of talent at all levels in our organizations,” Lange stresses.
KBI Biopharma is tackling this problem by working closely with educational institutions and large industry networks to create a sustainable workforce to support its growth. Lipinski observes that the need to ensure a workforce with the necessary depth of expertise is in part also driving larger biopharmaceutical companies to bring technology, capacity, and talent inhouse via acquisitions.
In general, summarized Bottone, access to key data in terms of capacity and capability is important for the biopharmaceutical industry as a whole, and leveraging these data to understand the current and potential challenges for all nodes of the supply chain, upstream and downstream, will facilitate the prioritization of near-term and long-term action. “The COVID-19 vaccine has paved the way for paradigm shifting innovation in accelerating new product introductions, enabling the industry to deliver breakthroughs that change patients’ lives,” she concludes.
References
1. Cobra Biologics, “Charles River to Acquire Cognate BioServices to Create a Premier Scientific Partner for Cell and Gene Therapy Development,” Press Release, Feb. 17, 2021.
2. Pall Corporation, “Pall Corporation Expands Production Capacity in the United States and Europe to Support Industry Demand,” Press Release, Jan. 7, 2021.
About the author
Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.This article first appeared in BioPharm International 34 (4) 2021.