Tina S. Morris, PhD, is vice president of Biologics & Biotechnology at United States Pharmacopeia (USP)
USP Product-Class Standards for Biologics
US Pharmacopeia develops and improves its class approach for ensuring quality biopharmaceuticals.
Industry Input Needed on Bioassay Standards
USP is advancing efforts to develop a guidance for evaluating bioassays.
Biological Potency Assays are Key to Assessing Product Consistency
Modern bioassays enable more accurate potency testing.