Fractionation, Plasma

Abstract

Blood plasma fractionation is a biopharmaceutical manufacturing operation in which high quality, proteinaceous products are prepared for clinical use from human plasma. Products prepared in this manner include albumin, eg, human serum albumin, and plasma protein fraction, for volume and protein replacement in surgery and for the treatment of injury and disease; coagulation factors, eg, Factor VIII and Factor IX Complex, for the prevention and treatment of bleeding disorders; and immunoglobulins, eg, immune serum globulin and immune globulin intravenous, for the prevention and treatment of infectious diseases and immune disorders. A number of highly integrated bioseparation processes are employed to fractionate human plasma into its different constituents. These range from established cold‐ethanol precipitation technology, devised in the 1940s, to more recently developed solid‐phase adsorption/desorption techniques. The principal developments since 1980 have been immunoglobulin products for intravenous use, and highly effective technologies for the inactivation of viral contaminants, such as hepatitis viruses and Human Immunodeficiency Virus (HIV), which were associated with earlier coagulation factor preparations.