Biological and biochemical assays to ensure the quality and safety of plasma-derived products: Factor VIII concentrates

The manufacture of coagulation Factor VIII concentrates fractionated from human plasma is subjected to a set of stringent quality control tests and quality assurance procedures. These requirements apply to all stages of product development and production, from the selection and quality control of the starting plasma source material to the purification, viral inactivation, storage and distribution phases of the final product in its pharmaceutical form. The present review addresses the major in-vitro and in-vivo analytical methods important to assess the potency, quality, and safety of coagulation Factor VIII products and to detect the presence of unwanted contaminants such as proteolytic enzymes and endotoxins.