By Rowel Tobias, William Hanshaw, Alan Leslie,
Paul Lightner, Glenn Petrie, and Mike Whalon
Sialylation of N-glycans in monoclonal antibody is an important quality attribute that could impact safety and ecacy of antibody therapeutics. The two most common N-linked Sialic acids in monoclonal antibodies are N-acetylneuraminic acid (Neu5Ac) and N-glycolylneuraminic acid (Neu5Gc). Neu5Gc could potentially elicit immunogenic response in mammalian system. A quantitative method for determining the amount of sialic acid was developed for characterization of a therapeutic monoclonal antibody. Analysis typically involves the hydrolysis of sialic acids from the antibody molecule and subsequent derivatization with a uorescent probe. Quantitation is based on calibration curve using commercially available standards. The current study describes the development and partial qualication of the sialic acid assay for antibody therapeutics.
Click here to download this ABC White Paper
Analytical Bio-Chemistry Laboratories
Sialylation of N-glycans in monoclonal antibody is an important quality attribute that could impact safety and ecacy of antibody therapeutics. The two most common N-linked Sialic acids in monoclonal antibodies are N-acetylneuraminic acid (Neu5Ac) and N-glycolylneuraminic acid (Neu5Gc). Neu5Gc could potentially elicit immunogenic response in mammalian system. A quantitative method for determining the amount of sialic acid was developed for characterization of a therapeutic monoclonal antibody. Analysis typically involves the hydrolysis of sialic acids from the antibody molecule and subsequent derivatization with a uorescent probe. Quantitation is based on calibration curve using commercially available standards. The current study describes the development and partial qualication of the sialic acid assay for antibody therapeutics.
Click here to download this ABC White Paper
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