To derive any therapeutic benefit from the plasma collected during the donations it must be processed. This processing technology is known as fractionation and it involves separating the various components of plasma into purified, concentrated products. These end products will translate into more efficient treatments of various diseases.
Fractionation involves the addition of ethanol at a low temperature to the plasma, in a process better known as Cohn fractionation. The first centrifugation step removes any cryoprecipitate, which is stored and used for the production of factor VIII. The remaining plasma is passed through a resin which captures factor IX. Finally, more ethanol is added to the rest of the plasma which is filtered and isolated to produce IVIG and albumin. Read our plasma derived products page to obtain more information about these lifesaving products.
General Steps for Plasma Derived Proteins Fractionation:
- Protein paste separation: To remove colloids, aggregated and non-product proteins, lipids and large particles
- Viral and Prion safety: Critical step to ensure removal of viruses known to have contaminated source plasma such as parvovirus, hepatitis viruses and HIV
- Chromatography purification: To improved protein recoveries and higher product purity as well as removal of viral inactivation agents, such as solvent/detergents.
- Ultrafiltration / Diafiltration: To reduce batch volumes and exchange buffer systems for efficient column operation and improve final formulation.
- Clarification and Pre-filtratio: To optimizes filtration clarifying and allows a cost-effective and convenient format to achieve a good balance between filter life and downstream protection.
- Sterile Filtration and Bioburden Control: To reduce bioburden and sterilize heat labile proteins
The following chart is a simplified scheme of fractionation process: