2020-07-13 11:17 The product is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with at least one molecule of polyethylene glycol (MW 20 kDa). It is purified from the culture medium using several chromatography columns. The purification process includes immunoaffinity chromatography, in which a monoclonal antibody directed against factor VIII is promoted to selectively isolate the factor VIII from the medium. The production process includes a viral inactivation solvent-detergent treatment step. The product molecule is then covalently conjugated with the polyethylene glycol, which primarily targets lysine residues.
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