What is Plasma Fractionation?
Plasma Fraction is the processs of separating the various therapeutic proteins within plasma donations into individual purified components. Plasma donated by healthy individuals contains over 100 biologically active components including albumin, immunoglobulins, clotting factors, and inhibitors. Through a multi-step procedure, fractionation splits plasma into its constituent parts to produce medicines that treat a wide variety of medical conditions.
The Plasma Fractionation Process
The first step in Plasma Fractionation is the collection of plasma through a process called plasma pheresis. During this procedure, whole blood is drawn from a donor and spun in a centrifuge to separate out the plasma. The remaining red blood cells are returned to the donor along with some of their plasma volume. This reversible blood donation process leaves donors able to donate more frequently than traditional whole blood donations. Once collected, the donated plasma undergoes a series of separation, purification, and viral inactivation steps. Cohn cold ethanol fractionation utilizes varying concentrations of ethanol and temperatures to differentially precipitate plasma proteins into separated fractions based on their solubility characteristics. Further chromatography and filtration refine these fractions into purified therapeutic products. Heating or chemical treatments eliminate potential viral contaminants to ensure the safety of these medicines for patient use.
Purified Plasma Derivatives
Through advanced fractionation technologies, manufacturers produce purified plasma protein therapies targeting specific medical indications: Intravenous Immunoglobulin (IVIG): IVIG contains antibodies (immunoglobulins) from thousands of donors. It is used to treat primary immunodeficiencies, COVID-19, neurological disorders, and autoimmune diseases by replacing missing antibodies or modulating the immune system. Albumin: As the most abundant circulating plasma protein, albumin maintains oncotic pressure and transports other substances in the blood. It is administered for volume expansion in trauma, surgery, burns, and other conditions involving hypovolemia or hypoalbuminemia. Coagulation Factors: Fractions containing clotting factors VIII, IX, and von Willebrand factor treat hemophilia A, B, and von Willebrand disease respectively to replace missing clotting factors. This enables control of bleeding episodes and prophylaxis. Alpha-1 Proteinase Inhibitor: This medication is given through intravenous and inhalation routes to treat genetic deficiencies of alpha-1 antitrypsin which can lead to emphysema or liver disease. It works by countering the effects of uncontrolled elastase in the lungs. Immunoglobulin for Intravenous and Subcutaneous Administration (IGIV and IGSC): Formulated for infusion or self-administered injection, these contain purified IgG antibodies and modulate immunity for immune deficiency and autoimmune conditions.
By separating whole plasma into concentrated therapeutic components, fractionation maximizes the value of each donation collected. It enables the treatment of diseases otherwise incurable and improves patients’ quality of life tremendously. Worldwide fractionation capacities allow manufacturing at scale to meet global demand for life-saving plasma medicines. These rigorously purified treatments produced through advanced technology foster continued medical progress and demonstrate plasma’s immense potential to help humanity.
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