Plasma-derived therapies are biologics extracted and purified from human plasma.
Plasma is the protein-rich liquid portion of the blood that remains after the removal of red blood cells, leukocytes and platelets and is the most abundant blood component. It is obtained from committed, healthy donors who donate their plasma in U.S. Food and Drug Administration and European Medicines Agency-licensed and industry-certified source plasma collection centers.
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.”
Plasma protein therapies help people of all ages fight chronic, often genetic diseases such as, primary immunodeficiency, hemophilia, alpha-1 antitrypsin deficiency, and serious, rare, neurological and autoimmune disorders. Plasma proteins are effective in treating these various disorders, and are separated from the plasma using a series of well-established purification methods, such as precipitation, centrifugation, separation and filtration. All plasma protein therapies are subject to viral removal and/or inactivation steps in the process to make life-saving therapies. These steps are effective in eliminating blood-borne infectious agents. This highly-complex production process requires substantial investment in equipment, training and quality control. It takes approximately seven to nine months from the initial plasma donation to the completion of the finished therapy.
Human plasma is processed and used in dozens of different life-saving plasma protein therapies. People who use therapies manufactured from human plasma rely on the generous donations made by committed individuals. To further improve the quality and safety of Source Plasma, PPTA developed the International Quality Plasma Program (IQPP) certification program for plasmapheresis centers.