THE CONTROL AND STANDARDIZATION OF FACTOR VIII

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Abstract
ABSTRACT:  Factor VIII concentrates have been used increasingly over the past decade for the treatment of patients with classical haemophilia. To ensure broad comparability between the potency estimates of therapeutic concentrates prepared by different manufacturers, a Factor VIII standard is required.The principles of biological standardization are discussed, particularly as they apply to the standardization of Factor VIII, both in plasma and concentrates.The role of the WHO International Standards is considered, as well as the importance of secondary standards. The control of Factor VIII concentrates by the regulatory authorities in the U.S.A. and the U.K. is also discussed. It is concluded that optimal control of Factor VIII concentrates requires a continuing interchange between producers, regulators and users.