EFFECT OF VON WILLEBRAND FACTOR ON THE ACTIVITY OF RECOMBINANT FACTOR VIII

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Comparison of potency tests of recombinant FVIII manufactured by Miles and by Baxter in the one and two stage assays and the chromogenic assay indicates an extraordinary degree of both interassay and intro-assay variability. Differences between individual runs of same assays can deviate up to 100% from the labelled potency. Predilution of both products in either albumin or factor VIII deficient plasma also affects the potency, with those samples prediluted in deficient plasma having overall higher values. It is planned to do in vivo half life and recovery studies.