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Subvisible Particles in Biotech Drugs

8/23/2011

E. Morrey Atkinson, Ph.D., CSO, VP of R&D, Cook Pharmica

Regulatory agencies are asking more questions about subvisible particles possibly present in some formulations and the potential of an immunogenic effect. Companies developing biotech drugs must gain a clear understanding of this issue if they hope to successfully compete in the pharmaceutical marketplace.


During this podcast Dr. Atkinson defines subivisible particles and talks about the top five issues that drug manufacturers absolutely need to know about such particles. He reviews the specific requests the FDA has made to the pharma industry for dealing with subvisible particles and discusses those analytical tools that are used most often to measure protein aggregates and subvisible/visible particles.

E. Morrey Atkinson, Ph.D. serves as  vp of R&D and CSO at Cook Pharmica. Dr. Atkinson is responsible for guiding the scientific direction of Cook Pharmica, relying on his past experience with process development of gene therapies, vaccines, recombinant proteins, and mAbs.

Dr. Atkinson has almost two decades of experience in biologic development and has held various leadership positions in biotechnology manufacturing and development. Most recently, he was head of biotechnology manufacturing sciences and technology for Eli Lilly in Kinsale, Ireland.

Dr. Atkinson, who grew up in Indiana and Florida, graduated from Indiana University with a B.S. in biology and received his doctorate in biological sciences from Stanford University.


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Genetic Engineering & Biotechnology News (GEN) has retained its position as the most widely read biotechnology publication around the globe since its launch in 1981. Published 21 times a year and with additional exclusive editorial content online, GEN's unique news and technology focus includes the entire bioproduct life cycle from early-stage R&D, to applied research including omics, biomarkers, as well as diagnostics, to bioprocessing and commercialization.

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