Blood Plasma Fractionation
The complexity of blood plasma proteins was first revealed through the invention of electrophoresis by the Nobel Prize winner, Arne Tiselius, in collaboration with Theodor Svedberg.
Thousands of plasma proteins have now been identified, and together with an estimated ten million immunoglobulins, make blood plasma a highly complex source of vital protein products for over one million people worldwide. Plasma proteins benefit, for example, patients suffering from antibody deficiencies and hemophiliacs.
The first industrial-scale process for plasma fractionation was developed during World War II by Edwin Cohn, USA, using differential solubility of plasma proteins to purify albumin, which was an excellent substitute for human plasma when treating shock patients. The method was developed further to purify other plasma proteins.
Since the early 1980s, chromatographic methods, in combination with ultrafiltration, have started to replace Cohn fractionation since they offer higher purity and yield, and are easier to automate. Chromatography is a gentle and reliable technique for purifying all plasma proteins on the market, including albumin, blood-clotting proteins such as factor VIII and factor IX, and immunoglobulins (IgG).
The removal or inactivation of pathogens such as viruses and prions is a vital aspect of plasma fractionation. Furthermore, high purity ensures a low risk of adverse drug reactions caused by contaminating substances. Viruses are inactivated in plasma products with solvent/detergent treatment and heat. The chromatography process itself removes viruses, prions, and endotoxins, and also the chemicals used in virus inactivation.
More recently, plasma proteins such as factor VIII have been cloned, allowing large-scale production of recombinant proteins. This step has essentially eliminated the risk of transmitting viral pathogens to exposed patients such as hemophiliacs. Purification of recombinant proteins frequently involves highly selective affinity chromatography.
The global demand for some blood plasma products is increasing by as much as 13% every year. Demand exceeds the supply, which is provided by a decreasing number of facilities. Most countries are dependent upon imports from other countries.
Becoming self-sufficient in plasma fractionation can help meet domestic demand, give control over economy and pathogen transmission, and provide the population with relevant immunoglobulin panels.
With decades of experience in plasma fractionation, GE Healthcare Life Sciences can offer a license-free, chromatography-based solution, with comprehensive training and full support to meet regulatory demands.