Plasma Fractionation: An Essential Process in Modern Biotherapeutics
Plasma fractionation is a highly specialized biochemical process used to separate and extract valuable proteins from human blood plasma. These proteins play a critical role in treating a wide range of disorders, including immune deficiencies, bleeding disorders, and chronic inflammatory diseases. Because plasma contains numerous proteins with distinct biological functions, fractionation helps isolate each component in a pure and usable form, enabling the development of life-saving therapeutic products.
The process begins with the collection of plasma from donors through plasmapheresis or whole-blood donation. Once collected, the plasma undergoes rigorous testing to ensure safety and quality. This step is crucial because plasma-derived products must meet stringent standards to prevent contamination and guarantee patient safety. Only plasma that passes these safety checks moves forward to the fractionation stage.
One of the most widely used techniques in plasma fractionation is cold ethanol fractionation, originally developed by Edwin Cohn in the 1940s. Although technology has advanced considerably since then, many modern fractionation systems still rely on modified versions of this method. Ethanol is added at low temperatures to precipitate proteins selectively based on their solubility. By adjusting factors such as pH, ionic strength, and ethanol concentration, scientists can isolate proteins such as albumin, immunoglobulins, clotting factors, and fibrinogen.
Albumin, one of the most abundant plasma proteins, is commonly used to treat shock, burns, and liver conditions due to its ability to maintain osmotic pressure. Immunoglobulins, on the other hand, are essential for patients with compromised immune systems. They provide passive immunity and help prevent infections. Clotting factors such as Factor VIII and Factor IX are critical for individuals with hemophilia, reducing bleeding risks and improving quality of life. The ability to obtain these proteins from a single plasma source makes fractionation an efficient and highly valuable process.
Modern plasma fractionation facilities often integrate chromatography, filtration, and viral inactivation technologies to enhance purity and safety. These advancements allow manufacturers to produce proteins with high consistency while minimizing the risk of viral transmission. Viral inactivation steps—such as solvent-detergent treatment or pasteurization—are essential safeguards that protect patients and reinforce confidence in plasma-derived therapies.
Plasma fractionation is not only a scientific process but also a logistical challenge. The demand for plasma proteins often exceeds supply, requiring coordinated donor recruitment and international plasma sharing systems. Ethical sourcing and stringent regulatory oversight remain vital to ensure that plasma collection respects donor welfare while supporting global healthcare needs.