Ph.D Kevin Carrick
USP Standards for Therapeutic Proteins. Estándares USP para proteínas terapéuticas
DATOS DEL AUTOR
USP Global Biologics /EEUU
Dr. Carrick is a Senior Scientific Liaison in the Global Biologics department at the USP. He is the lead Liaison for the Biologics and Biotechnology expert committee 3 focused on development of standards for complex biologics. He received his Ph.D. from the University of North Carolina at Chapel Hill in Biochemistry and Biophysics. Prior to joining the USP he worked at ProMetic BioTherapeutics as the Associate Director of Product Characterization where he directed the characterization of several drug substances in preclinical development. Dr. Carrick has also held positions, as group leader for protein characterization at the American Red Cross and as an associate director at the University of North Carolina at Chapel Hill Proteomics facility.
RESUMEN DE DISERTACIÓN
The USP Global Biologics department develops monographs and associated general chapters in the area of biotherapeutics. Various methodologies are used for the purposes of establishing identity, strength, quality, and purity of biotherapeutics. Chromatography, electrophoresis, and bioassays are examples of methods used to address key quality attributes covered in USP standards. This presentation will describe the process of developing these standards.