The preparation of plasma products

Plasma products are medicinal products that are prepared on a large scale from human blood and/or blood plasma. The acquisition of blood and the preparation of plasma products occur under Good Manufacturing Practice (GMP) conditions. This is a quality system that ensures that medicinal products are produced in a consistent manner and checked on the basis of the specified standards of quality. The quality of every plasma product is guaranteed through checks on biological activity, purity, sterility and specific product characteristics (as well as during the preparation phase as on the end products).
Plasma products are prepared using protein separation techniques. Various fractions are isolated from the plasmapool in stages from which multiple plasma products are subsequently prepared.

As the first step in the fractionation process the plasma is brought to the Sanquin production facility in a frozen state and thawed in a special controlled manner. By slowly thawing the plasma at a temperature just above freezing point (cryoprecipitation), a deposit forms (the so-called cryoprecipitate). A number of clotting proteins (including, the important clotting factor VIII) are found in this cryoprecipitate. This factor VIII protein is the first product obtained through plasma fractionation and is marketed under the name of Aafact®.

Units of frozen plasma

The major portion of the plasmapool (cryo-poor plasma) remains after the cryoprecipitation phase. This cryo-poor portion undergoes ion exchange chromatography to obtain the clotting factors II, VII, IX and X. This concentrate is also called four clotting factor concentrate or prothrombin complex (pcc), marketed as Cofact®. A highly purified factor IX product (Nonafact®) is also isolated.
The protease inhibitor, C1 esterase inhibitor, Cetor® is prepared in a similar manner from cryo-poor and pcc-poor plasma.
After the isolation of these clotting factor products and the protease inhibiting product, the next step in the production process is alcohol fractionation. In addition to the normal immunoglobulin products, GammaQuin® (for intramuscular use) and Immunoglobuline I.V. (prepared from plasma of unselected donors), there are also a number of specific immunoglobulin products made. These products are prepared from the plasma of specific donors and contain antibodies that are specifically directed against certain foreign entities. Sanquin produces the following specific immunoglobulin products: VariQuin® (human varicella zoster immunoglobulin, HepBQuin® (human hepatitis B immunoglobulin) Hepatitis B Immunoglobuline 300 IE (human hepatitis B immunoglobulin 300 IU), TetaQuin® (human tetanus immunoglobulin and RheDQuin® (human anti-Rhesus (D) immunoglobulin).
The alcohol fractionation is also used to produce the albumin products Cealb® and G.P.O. (Gepasteuriseerde Plasme-eiwit Oplossing)

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