The complexity of biotherapeutic products and their manufacturing processes can yield a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. These impurities can be broadly grouped into two categories: 1) product-related impurities, such as precursors, aggregates and degradation products, and 2) process-related impurities, such as host cell DNA, host cell protein, and particulates. This presentation will provide an overview of approaches for monitoring impurities, including a discussion of existing USP standards and standards under development to support impurity testing.
Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia
Dr. McCarthy is a Senior Manager, Science and Standards within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.