Documents CQA Assessment for Glycosylation and Oxidation of a Monoclonal Antibody: An FDA OBP Pilot Program...

Slide 1 CQA Assessment for Glycosylation and Oxidation of a Monoclonal Antibody: An FDA OBP Pilot Program Case Study Andrew Weiskopf, Ph.D. 2010 WCBP CMC Strategy Forum 19…