To check the pulse of an industry, it never hurts to simply ask around. So, I contacted a collection of bioprocessing experts from around the world, and asked them one question: What is today’s biggest challenge in bioprocessing?

The answers fell into two general areas, so this will be a two-part series. First, let’s read what experts think about advances in bioprocessing that will impact patients.

David B. Weiner, PhDDavid B. Weiner, PhD, executive vice president, The Wistar Institute: COVID-19 and the response to it by pharma has changed bioprocesses forever. One thing we have learned is that speed to the clinic and rapidly being able to move to large-scale production is central. Platforms and technologies that increase speed and maintain safety and quality are only going to grow in importance.”

Andrew Zydney, PhD Andrew Zydney, PhD, Bayard D. Kunkle Chair chemical engineering professor, Penn State University: “In the short-term, the biggest challenge in bioprocessing is developing the manufacturing capacity needed to produce low-cost vaccines and biotherapeutics that can effectively address the challenge of COVID-19. Longer term, I think the greater challenge facing bioprocessing lies in developing effective manufacturing processes to enable widespread application of novel biotherapeutics (e.g., CAR-T therapies, nanoparticles for delivery of nucleic acids, antibody-drug conjugates, etc.) for which we currently lack well-established production/purification strategies.”

Steven Pincus, PhDSteven Pincus, PhD, head of science and innovation, FUJIFILM Diosynth Biotechnologies Texas: “A challenge in bioprocessing is establishing an appropriate manufacturing process for personalized medicines. The process has to produce enough material to support release testing, treat the patient, and maintain some retain in case questions arise. The testing challenge is both the amount of material needed and the time required to obtain results.”

Tracey Mullen
Tracey Mullen, CEO, Abveris

Tracey Mullen, CEO, Abveris: “Advancing clinical drugs to patients as quickly as possible requires a delicate balance of quality and throughput. Innovative, high-content screening tools aid in upstream identification and optimization of lead candidates, but as therapeutic targets continue to present new challenges, additional tools will be required to enable rapid, yet accurate, development.”

Perhaps more than ever, bioprocessing experts think about the necessary speed of getting new therapeutics to patients. At the same time, the COVID-19 pandemic forces bioprocessors to think ahead.

Next week, I’ll talk with bioprocessing experts about some of the technologies that promise improved performance in the future.

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