What is Plasma?
Plasma is the clear, straw-colored liquid portion of the blood that remains after the removal of red blood cells, leukocytes, platelets and other cellular components. Plasma comprises around 55 percent of human blood and contains water, salts, enzymes, antibodies and other proteins. Human plasma is the source of proteins and antibodies including albumin, clotting factors, immunoglobulins and fibrinogen, which are used to make therapies that treat rare, chronic, and often genetic diseases such as hemophilia, primary immune deficiencies, genetic emphysema, and is used to treat medical conditions such as shock, trauma and burns. Therefore, plasma is the essential starting material for a wide range of life-saving medicines.
Plasma Protein Therapies are Unique
The biological nature of human plasma provides particular challenges to obtaining safe starting material and manufacturing high-quality therapies. The process of collecting plasma and manufacturing plasma protein therapies are stringently regulated by regulatory agencies such as the U.S. Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products.
Plasma obtained specifically from plasma donors is collected through a procedure called "Plasmapheresis." A donor's blood is drawn through a needle in the arm into a highly-specialized piece of medical equipment that separates red blood cells and other cellular components from the plasma, and then returns them to the donor. This type of plasma is called "source plasma." Plasma that is collected from whole blood donations made at blood banks, hospitals and other blood centers currently is called "recovered plasma."
Manufacturing Therapies Is Complex
Plasma fractionation is the process in which specific proteins are isolated from human plasma and then used to manufacture various therapies. Different purification methods have been developed based on the individual physico-chemical properties of the protein classes. Following fractionation, the finished therapies are packaged for distribution. Each lot of manufactured therapies is reviewed before being approved for release.
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