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Plasma Fractionation: How Blood Plasma is Separated into Life-Saving Therapies

What is Plasma Fractionation?
Plasma Fraction is the process of separating whole blood plasma into its individual components or fractions - proteins, coagulation factors, immunoglobulins, and other biologically active substances. Plasma, the liquid part of blood, contains over 7,000 different proteins and other molecules that serve various important functions in the human body. Through Plasma Fraction, specific proteins can be purified and concentrated to develop treatments for diseases and medical conditions.
The Plasma Fractionation Process
The first step in Plasma Fractionation involves collecting plasma from healthy blood donors. Whole blood donations are centrifuged to separate out the plasma, which is then frozen and transported to a Plasma Fraction facility. Here, the frozen plasma undergoes a series of separation and purification steps using advanced technologies like chromatography and filtration.
The primary fractionation method uses cold ethanol fractionation. In this process, cold ethanol is added to thawed plasma batches under carefully controlled temperature conditions. This causes the various proteins in plasma to separate or precipitate out of solution at different concentrations of ethanol.
The precipitated protein fractions are then isolated, washed, and further purified using additional techniques. For example, ion-exchange chromatography separates proteins based on electric charge, and size-exclusion chromatography separates them based on molecular size. Ultrafiltration and viral filtration steps remove unwanted components and viruses.
The purified protein fractions or intermediate products are individually collected, formulated, and underwent viral inactivation or other safety steps. They are then sterile-filtered and aseptically filled into containers to produce the final plasma protein therapies. Strict quality controls ensure the purity, potency, and safety of these end products.
Major Plasma Protein Products
Intravenous Immunoglobulin (IVIG)
One of the main fractions produced is IVIG, which contains antibodies or immune globulins collected from thousands of donor plasma samples. IVIG therapy helps treat primary immune deficiencies by providing a replacement for missing antibodies. It is also used for other conditions where immunoglobulins play a role, such as immune thrombocytopenic purpura (ITP) and Kawasaki disease.
Albumin
Albumin makes up about half the protein content in blood plasma. Purified human albumin is used mainly for volume expansion in conditions like trauma, surgery, burns, and liver disease. It restores fluid balance in shock or low blood volume episodes.
Coagulation Factors
Hemophilia A and B are bleeding disorders caused by deficiencies in clotting factors VIII and IX, respectively. Plasma Fraction allows isolation of pure therapeutic factor concentrates for treating these conditions. Concentrates of other essential clotting factors like factor VII and XIII are also derived.
Immunoglobulin Fragments
Snakebites and other envenomations are treated with fragments of immunoglobulins like antivenoms, which work by neutralizing venom toxins. Monoclonal antibodies against hepatitis A, rabies, varicella zoster, and other pathogens are obtained through recombinant DNA technology using fragments from plasma as templates.
Other Proteins
Protein C concentrate is used for treating purpura fulminans and hereditary protein C deficiency, while antithrombin III concentrate helps manage congenital antithrombin deficiency. Alpha-1 proteinase inhibitor replenishes levels in individuals with alpha-1 antitrypsin deficiency that predisposes to lung disease.
Lifesaving Therapies from a Single Donation
Through Plasma Fraction, a single 1-unit plasma donation has the potential to help multiple patients receive various life-sustaining therapies. For example, a 700mL donation can produce enough albumin to treat shock in two burn patients or IVIG to treat immunodeficiency in two children. Due to the complexity of fractionation, a global plasma supply chain comprising collection centers, fractionators, and distributors work together year-round to meet worldwide demand. With continued innovation, more orphan plasma proteins stand to benefit many rare disease communities in future.
Plasma Fraction is a sophisticated process that separates blood plasma into individual purified components. This allows development of safe and effective therapies targeting specific diseases and conditions from immune deficiencies to bleeding disorders. Regular plasma donations are essential to sustain fractionation operations and improve access to these life-saving and life-enhancing protein medicines worldwide.
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