Beyond the human suffering and economic damage caused by COVID-19, one of the most powerful results of the pandemic has been to focus global attention on drug and vaccine development for infectious diseases. Massive investments by governments, institutions, and biopharmaceutical companies have accelerated development of novel therapeutics, including messenger RNA (mRNA) and viral-vector vaccines, that are poised to become transformational platform technologies for biopharmaceutical manufacturing (1). Furthermore, the well-established technology of monoclonal antibodies (MAbs) has lived up to its promise to deliver treatments and potentially preventive therapeutics for the SARS-CoV-2 virus (2).
Such dynamics will intensify what was already a challenging constraint facing the biopharmaceutical industry; namely, expanding and training the workforce it needs to meet growing global demands for vaccines and advanced therapeutics (3). Higher-education curricula and workforce training programs need to adapt to this emerging industrial landscape. Their developers should broaden content to support new technologies while also expanding the workforce development needed to make established and next-generation biologics — which already had been fast-growing segments of the prepandemic biopharmaceutical market.
New Academic Model
Most academic programs in the United States that focus on bioprocess development and biomanufacturing are concentrated in engineering schools and community colleges. At the latter, introductory programs prepare students for entry-level positions in biomanufacturing. Engineering degree programs do what their name suggests: focus on the engineering aspects of bioprocess technology. In addition to those applied degrees, university doctoral programs in life sciences feed talent to the industry’s research and development laboratories.
As a rule, baccalaureate life-sciences programs across the United States provide little or no exposure to the methods and processes used today to develop, scale up, and manufacture biopharmaceuticals. Adding key bioprocessing courses and laboratory experiences to existing baccalaureate programs presents an opportunity to enhance students’ career opportunities and expand significantly the available talent pool.
Albany College of Pharmacy and Health Sciences (ACPHS) in New York is a pioneer of this new academic model. In 2021, ACPHS will open its Center for Biopharmaceutical Education and Training (CBET), the first facility of its kind at a pharmacy college in the United States. I am privileged to be its founding director.
The pharmacy college designation does not describe fully the extent of ACPHS’s academic programs. Our curriculum delves deeply into the biology of human disease and the science of large- and small-molecule drug activity, development, and formulation. Most ACPHS students become working pharmacists, but a growing number are earning degrees in microbiology, pharmaceutical science, and public health. In fact, many of the school’s alumni already are working in the biopharmaceutical industry, with several of them now in leadership roles.
Given the expanding role of biopharmaceuticals and the complexity of their development, production, formulation, and administration, the faculty and leadership at ACPHS realized that their institution is positioned perfectly to play a larger role in helping the industry grow, not only through drug dispensing and patient management, but also in biologics development and manufacturing. After years of planning, CBET now operates a new bench-scale bioprocessing facility that will provide students with hands-on experiences in a simulated current good manufacturing practice (CGMP) environment.
The program will include cell culture and microbial fermentation processes to produce antibodies, recombinant proteins, enzymes, and other biologics. The center also is equipped for cell therapy and gene therapy development projects. At CBET, students will learn all aspects of upstream and downstream bioprocessing, with emphasis on quality assurance and quality control (QA/QC). In the next few years, CBET plans to add pilot-scale laboratories and an aseptic fill–finish training facility.
Our initial academic program will offer 10 graduate-level courses, which also will be open to some undergraduates at ACPHS. Juniors and seniors who have satisfied prerequisites can choose electives through CBET to add hands-on experience to their degrees. Graduate students at ACPHS, including those pursuing a doctor of pharmacy or master’s degrees in pharmaceutical science and molecular biosciences, also can choose courses at CBET. Julian Rosenberg, PhD (a Johns Hopkins University–trained bioengineer and CBET’s associate director), is leading a new one-year master’s program in biomanufacturing and bioprocessing designed for recent graduates or early career employees. This intensive 33-credit program includes a capstone project with a paid internship at a biopharmaceutical company. Graduates from the program will be positioned perfectly to make an impact within the industry.
By design, CBET opens new career pathways for students who are drawn to biopharmaceutical sciences and the potential of advanced therapeutics to improve people’s lives. Students will gain an understanding of the diverse jobs available, and we will align our programs with the emerging needs of the industry by working closely with an advisory group of biopharmaceutical leaders, including several ACPHS alumni.
Short-Form Training Programs
Along with expanded degree programs, competency-based training programs also must evolve to meet the growing demands for biomanufacturing workforce development. The US Food and Drug Administration (FDA) expects biopharmaceutical companies to offer internal training programs for new hires before those employees can work on actual processes. Companies devote significant time and resources to lessen risks of human error that can result in process deviations, contamination, or batch-failure. However, such internal training programs usually are designed for a few trainees at a time, not for larger groups.
Internal training programs are becoming insufficient for on-boarding new employees and enhancing the skill sets of existing ones. By leveraging external workforce training programs, a company can customize group programs that use its own standard operating procedures (SOPs) but run externally without putting actual products at risk. Such programs can help biomanufacturers optimize processes to incorporate new technologies for improving yield and product quality and reduce processing times. High-throughput instruments, automation, process intensification, single-use systems, continuous processing, and process analytical technologies (PATs) are among the key tools companies are incorporating to achieve those goals.
Flexibility Has Become Critical: Increasing interest in orphan drugs and personalized therapies is leading to production of smaller batches for increasing numbers of products. As outsourcing projects proliferate, contract development and manufacturing organizations are expanding and multiplying. Employees of those companies must acquire abilities to move from one process to another quickly and (ideally) to develop skills across the biomanufacturing continuum, both for upstream and downstream processes and across expression systems and technology platforms. External programs can be a better choice for such cross-training because they allow people to challenge themselves and learn quickly without compromising actual therapeutic production.
Addressing the Needs of Displaced Workers: External training programs also can help workers who have been displaced from other industries to adapt their skills for a biomanufacturing setting. For example, in 2015, a semiconductor manufacturing facility in Massachusetts was preparing to shut down. Nearly 700 people were slated to lose their jobs. Before that plant closed, the Massachusetts Department of Labor and Workforce Development reached out to my colleagues at Worcester Polytechnic Institute and me, asking us to develop a program to help retrain the workers (4). The state provided tuition grants for qualifying displaced workers, and WPI adapted its curriculum to help that cohort transfer their skills. As state and federal governments contemplate additional economic recovery and stimulus programs to help the millions of people who have lost their jobs because of COVID-19 restrictions, funding for biomanufacturing workforce training should become a priority.
It would be advantageous for other states to build coalitions with specific manufacturing companies and regional educational institutions to develop customized training programs that help match transitioning workers to the needs of specific companies and industries.
Programs designed to help US veterans who are leaving military service also would be appropriate because many of those individuals have capabilities that could be adapted to work in biomanufacturing.
Expanding Regional Training Opportunities: An important benefit of increasing the number of academic programs that incorporate bioprocessing centers will be to grow the number of regional facilities across the country that can offer customized short-course training programs. This also is part of our model at CBET. For example, in 2021 we will offer a program on upstream processing using mammalian cell culture systems, providing experience in culturing suspension as well as anchorage-dependent cells used for vaccine manufacturing. The program will include batch, fed-batch, and perfusion cultures, with emphasis on process design, scale-up strategies, media optimization, quality control, and error prevention for risk mitigation. We also will have a fermentation course that introduces generation of recombinant strains, microbial growth and bioprocessing, scale-up strategies, and fermentation vessel design. PATs, process intensification techniques and strategies, design of experiments (DoE), strain screening, and optimization of media and growth also will be covered.
Our four-day downstream program addresses aspects of protein separation and purification strategies including cell disruption, centrifugation, filtration, and chromatography techniques, with some coverage of final-product QA/QC. The program also will include some high-throughput proteomics and use of mass spectrometry in protein identification.
Those are just three examples of CBET programs in our inaugural year, with many others offered for specific cohorts of incumbent biopharmaceutical workers (5).
Pursue the Technology Horizon
The public health imperative to expand global biomanufacturing capacity to respond to a pandemic is not new. Among similar efforts in recent years is a program developed at Utah State University that was funded by the US Department of Health and Human Services through its Biomedical Advanced Research and Development Authority (BARDA) in collaboration with the World Health Organization (WHO) (6). At the time, the focus was on a potential influenza pandemic. BARDA and WHO understood that among the key constraints for developing regional manufacturing capacity is the availability of a trained biomanufacturing workforce that understands the processes involved and the rigors of working in a CGMP environment to produce needed vaccines.
From 2010 through 2013, my colleagues and I developed and delivered an intensive vaccine manufacturing training program for scientists and biomanufacturing staff from several countries, including Egypt, Indonesia, Kazakhstan, South Korea, Romania, Russia, Serbia, South Africa, Thailand, and Vietnam. An essential element of the program was to introduce new technologies. In addition to training people on the egg-based method (which remains the principal modality for influenza-vaccine production), we introduced them to novel cell-based manufacturing systems. Such systems offer many advantages over egg-based production, and we wanted to encourage manufacturers to adopt those new technologies to improve their domestic manufacturing capabilities by preparing workers for those innovations.
Today, our training and academic programs in the United States must do the same. The potential impact of novel vaccine technologies is being validated day by day. Continuing results from clinical trials around the world — and the data being collected as some of those vaccines are being administered on large scales — are confirming the effectiveness of mRNA and recombinant viral-vector vaccines against SARS-CoV-2.
Novel platform technologies can be adapted rapidly to target other viruses and already are being used for preclinical development of therapeutics for other disease states, including cancer (7). So our current array of biomanufacturing workforce development programs should add training modules other emerging technologies.
Although mRNA vaccine production is a hybrid chemical and enzymatic process that differs from traditional biomanufacturing, it is part of the vanguard of cell-free bioprocessing systems that hold promise for transforming many aspects of biologics manufacturing in the future (8). That modality needs to be integrated into comprehensive workforce development initiatives. Simultaneously, we need more workforce programs that support current and near-current biologics. Standard MAbs are the economic foundation of the industry today and will be for some time. New waves of advanced antibodies — bispecific antibodies, antibody fragments, antibody–drug conjugates (ADCs), and other biological entities — are in different stages of development for a wide range of disease states. To meet the demand for such products, there remains a growing need to expand workforces for established biomanufacturing processes.
Given the current global focus on COVID-19, this is a time when smart, public-health–oriented young people can be inspired to pursue careers in the biopharmaceutical industry through broader offerings in undergraduate life-sciences and bioengineering programs. Furthermore, millions of other people who either have lost jobs or are rethinking their career choices could find a future in this industry — with the appropriate training. It’s up to academic institutions, companies, and public policy makers to work together to seize this moment and expand the programs that help prepare people for success in the biopharmaceutical industry.
1 van Riel D, de Wit E. Next-Generation Vaccine Platforms for COVID-19. Nat. Mater. 19(8) 2020: 810–812; https://doi.org/10.1038/s41563-020-0746-0.
2 Ejemel M, et al. A Cross-Reactive Human IgA Monoclonal Antibody Blocks SARS-CoV-2 Spike-ACE2 Interaction. Nat. Commun. 11(1) 2020: 4198; https://doi.org/10.1038/s41467-020-18058-8.
3 Rader R, Langer ES, Jhamb K. COVID-19 Impact on Bioprocessing: Accelerating Trends and Long-Term Impact of Novel Coronavirus-19 on Biomanufacturing and Bioprocess Supply Chain. BioPlan Associates, June 2020; https://bioplanassociates.com/wp-content/uploads/2020/07/Covid-19-Impact-on-Bioprocessing-White-Paper-BioPlan-20200605.pdf.
4 From Chips to Proteins: Former Intel Employees Begin Biomanufacturing Training at WPI. Worcester Polytechnic Institute (WPI)media release, 2015; https://www.wpi.edu/news/intel.
5 CBET Industry Training; https://cbet.acphs.edu/industry-training.
6 Tarbet EB, et al. Vaccine Production Training to Develop the Workforce of Foreign Institutions Supported By the BARDA Influenza Vaccine Capacity Building Program. Vaccine 31(12) 2013: 1646–1649; https://doi.org/10.1016/j.vaccine.2012.06.041.
7 Servick K. Messenger RNA Gave Us a COVID-19 Vaccine. Will It Treat Diseases, Too? Science, 16 December 2020; https://www.sciencemag.org/news/2020/12/messenger-rna-gave-us-covid-19-vaccine-will-it-treat-diseases-too.
8 Melinek B. et al. Toward a Roadmap for Cell-Free Synthesis in Bioprocessing. BioProcess Int. 18(9) 2020: 40–52; https://bioprocessintl.com/wp-content/uploads/2020/09/18-9-Melinek.pdf.
Kamal A. Rashid, PhD, is professor of basic and clinical sciences and pharmaceutical sciences at the Albany College of Pharmacy and Health Sciences and the founding director of the college’s Center for Biopharmaceutical Education and Training; email@example.com.