Plasma is the aqueous part of blood containing proteins and salt in which red and white blood cells and platelets are suspended. It constitutes approximately 55 percent of total blood volume. Important elements in plasma include albumin, coagulation factors, fibrinolytic proteins, immunoglobulin and other proteins.
Plasma usually is frozen within hours of donation in order to preserve the clotting factors. Frozen plasma products have a 12-month life span and are transfused within 24 hours of thawing. Plasma products are indicated for use in several treatments, including to treat bleeding disorders when a patient is deficient in one or multiple clotting factors and no factor-specific concentrate is available, and initial treatment of patients who are undergoing massive transfusion because of life-threatening trauma/hemorrhages and who have clinically significant coagulation deficiencies. Some plasma products are not used for direct transfusion but are shipped for further manufacture where they are separated into specific products, including albumin, clotting factors and intravenous immune globulin.
AABB works on behalf of donors and patients to ensure the safe and effective collection, processing and use of plasma. In performing this work, the association communicates directly with federal agencies, including the Food and Drug Administration and the Centers for Medicare and Medicaid Services, advocating for appropriate guidance, regulations and reimbursement for plasma. AABB also has worked on behalf of the community to gain recognition and licensure of recovered plasma for further manufacture.
Scott Gottlieb, MD, commissioner of the Food and Drug Administration (FDA), and Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, issued a statement of caution in response to reports that facilities in several states are offering plasma infusions from young donors as treatment for a variety of conditions.
The FDA released a draft guidance that provides assistance to “manufacturers, sponsors and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma products in the United States.”
The United States Food and Drug Administration granted an emergency use authorization (EUA) to the U.S. Department of Defense (DOD) enabling the emergency use of pathogen-reduced leukocyte-depleted freeze-dried plasma (referred to in the EUA as French FDP) for the treatment of hemorrhage or coagulopathy of U.S. military personnel in combat settings where plasma is either unavailable or impractical for use.
FDA clarified their considerations for Concurrent Plasma and Component Plasma to the BPAC. AABB noted particular GMP concerns with the proposal.
February 24, 2021
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February 08, 2021