KurtBrorson,Ph.D.pptVIP

Kurt Brorson, Ph.D. Division of Monoclonal Antibodies OPS/CDER Heterogeneity in recombinant products and Monoclonal antibodies Cell culture related Fermentation is an artificial process vs. plasma or other natural sources Bioreactor conditions can impact: Glycosylation Some charge variants Amino acid substitutions (leu ? norleucine, etc) The cell line can impact: Adduct placement Folding/misfolding Cysteine pairing Heterogeneity in recombinant products and Monoclonal antibodies Stability related Pure, high concentration protein is an artificial system vs. proteins in cells or bodily fluids P