Plasmaderived

Plasmaderived, more commonly written plasma-derived, describes medicines and biological products manufactured from human plasma. These products are produced by fractionating plasma pools collected from healthy donors and purifying specific proteins.

Plasma is obtained via plasmapheresis; supply is processed and stored for fractionation. Fractionation processes (such as Cohn fractionation and chromatography) produce targeted proteins. Modern manufacturing includes viral inactivation and clearance steps like solvent/detergent treatment, pasteurization, low-pH treatment, and nanofiltration to reduce the risk of transmitting blood-borne pathogens.

Common plasma-derived products include immunoglobulins (intravenous or subcutaneous IgG), clotting factor concentrates (factor VIII for hemophilia A, factor IX for hemophilia B), albumin, and other plasma proteins such as alpha-1 antitrypsin. Indications span immune deficiencies, autoimmune diseases, bleeding disorders, and certain critical care or transplant-related uses; some products have specialized applications in neurology or other fields.

Safety and regulation: extensive donor screening and infectious agent testing are complemented by viral inactivation and purification steps to minimize risk. Adverse reactions can occur but are closely monitored. Regulatory oversight by agencies such as the FDA and EMA, along with adherence to good manufacturing practice, governs production and labeling. Price, supply, and manufacturing capacity can influence availability, and plasma-derived products compete with recombinant therapies for some indications.

History and context: plasma-derived products emerged from early plasma fractionation methods in the mid-20th century and became essential tools in modern medicine. Today they remain widely used where recombinant alternatives are not suitable or cost-prohibitive, and they continue to be refined in safety and supply management.