Quality control of biologics produced from mammalian cell lines (monoclonal and bispecific antibodies, fusion proteins, antibody-drug conjugates, and other recombinant proteins).
Quality control of biologics produced from mammalian cell lines (monoclonal and bispecific antibodies, fusion proteins, antibody-drug conjugates, and other recombinant proteins).
Quality control of intermediate product by: capillary electrophoresis, ion-exchange HPLC identification and glycosylation modification analysis. The molecular size variant is quantitatively analyzed by SDS-PAGE, CE-SDS and SEC. The charge variant is quantitatively analyzed by HIC-HPLC. Activity equivalent index is used for quantitative analysis. The specific extinction coefficient of 280 nm and spectrophotometry are used to determine content. ELISA and qPCR are used to determine impurity.
Quality control of drug product through physical and chemical analysis such as pH, osmotic pressure, molar concentration, insoluble particles, water content sterility, bacterial endotoxin, and abnormal toxicity. Capillary electrophoresis, ion-exchange HPLC, peptide mapping and other methods are used for identification and glycosylation modification analysis. The molecular size variant is quantitatively analyzed by SDS-PAGE, CE-SDS and SEC. The charge variant is quantitatively analyzed by HIC-HPLC. Biological and binding activity equivalent value are used for quantitative analysis. The specific extinction coefficient of 280 nm and spectrophotometric method are used to determine the protein content.