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Monoclate® (Rorer/Armour Pharmaceuticals Division) is a highly purified Factor VIILC preparation derived from human plasma by immunoaffinity chromatography. As described in an accompanying report in these proceedings [1], Monoclate® is a stable Factor VIILC preparation of specific activity between 800–4500 IU/mg protein, prior to the addition of human serum albumin as a component of the parenteral formula. A key manufacturing step of the Monoclate® process is the absorption of Factor VIII:C-von Willebrand factor complexes from cryoprecipitate to monoclonal antibodies specific for von Willebrand factor, that are immobilized on a solid phase resin. In preclinical studies, the composition of Factor VIII in Monoclate® preparations appears to be indistinguishable from that in either currently commercially available impure concentrates of plasma or recombinant DNA derived material. |
