Ben Clarke
Senior Scientist, Global Biologics U.S. Pharmacopeia
Dr. Ben Clarke comes from the United States Pharmacopeia’s Global Biologics group, where he coordinates collaborative multi-laboratory studies for USP’s physical reference standards. The standards he supports include those for monoclonal antibodies, cell, and gene therapy. Before joining USP, Ben developed potency bioassays at GSK Vaccines for RSV and mRNA vaccines. His post-doctoral research at the National Institutes of Health involved the development of mouse models using the emerging CRISPR/Cas9 genome editing technology. He received his Ph.D. in Cell Biology from Cornell University and his B.S. in Biochemistry from Pennsylvania State University.
Seminars
- Opening up discussion on proposed revisions to USP Chapter 1043, with a focus on the 4-tier risk assessment system
- Bringing together differing views on the tiered approach, encouraging participants to share perspectives and challenge assumptions
- Exploring what these potential changes mean in practice for raw material risk assessment and decision-making
- Discussing USP Chapter <1043> on ancillary material quality, risk assessment and material qualification
- Noting recent developments in compendial methods for raw materials