- Plasma Collection
Inventory Hold, Lookback and Traceability
What is Plasma?
CSL Behring biotherapies are derived from human plasma. Plasma is the portion of blood that remains after red cells, leukocytes (white blood cells) and platelets are removed. Plasma consists of water, salts, enzymes, albumin, antibodies and other proteins. Plasma proteins perform a variety of roles, including clotting blood, fighting diseases and other critical functions. In addition to plasma, some of our therapies use recombinant DNA technology. With this technology, proteins are synthesized in genetically engineered cell lines.
Once donors are certified as eligible to donate, a portion of their plasma is collected through an automated procedure called plasmapheresis. Plasmapheresis is the process of removing whole blood and separating the cellular components from plasma. The donor’s blood is drawn through a tube into a machine that separates the cellular components from plasma. The cellular compounds (red blood cells, white blood cells and platelets) are returned to the donor during this process, which takes less than one hour. The plasma is retained for use in preparing medicinal products. Whole blood donors lose part of the oxygen-carrying capacity of the blood, which is restored relatively slowly. Plasma donors only lose the proteins in plasma while retaining their capacity for oxygen transport. Since plasma proteins are synthesized more rapidly than blood cells, it is possible to collect plasma more frequently and in larger volumes than whole blood donations.
Plasma used for production is derived from either source plasma or recovered plasma. Source plasma is collected through plasmapheresis. Recovered plasma is obtained from carefully selected whole blood donations. Selection criteria for recovered plasma donors are comparable to those for source plasma. Furthermore, both source and recovered plasma are subject to our rigorous quality control standards.
Safety in Plasma Collection
CSL Behring owns and operates CSL Plasma, one of the world’s largest and most sophisticated plasma collection networks with centers in the United States and Germany. By collecting our own plasma, we are assured of the highest quality and purity of our source materials.
||CSL Plasma holds a corporate certification from the International Quality Plasma Program (IQPP) for plasma collection safety and quality standards. This program establishes voluntary standards that meet or exceed regulations around the world. To become certified, each of our plasma collection centers must meet these standards and pass all random inspections.
In the United States, CSL Plasma participates in the National Donor Deferral Registry (NDDR), developed by PPTA and designed to be used by plasma centers to check donors against a computerized list of permanently deferred donors. This system serves to further assure the safety of plasma and plasma products. Implementing a European NDDR is currently being discussed by several European and National Regulatory Authorities.