by Blood plasma is the liquid component of blood that remains after red blood cells, white blood cells, platelets, and other cellular components are removed. It accounts for approximately 55% of total blood volume. Plasma acts as a transport system for carrying cells, nutrients, waste products, hormones, and blood clotting factors to and from cells. By volume, 92% of plasma is water, while the remaining 8% contains vital proteins, glucose, clotting factors, electrolytes, antibodies and hormones.
Isolation of Plasma Components
Plasma can be separated into its different components through a process called fractionation. During fractionation, plasma constituents are isolated based on differences in their physical and chemical properties such as size, charge, solubility and binding affinity. This process involves steps such as precipitation, chromatography, electrophoresis and incubation. The major Blood Plasma Derivatives isolated through fractionation are albumin, immunoglobulins, clotting factors and protease inhibitors.
Albumin
Albumin is the most abundant plasma protein in humans, making up about half of plasma protein content. Its main function is to regulate colloidal osmotic pressure in blood vessels and transport hormones, fatty acids, metabolites, calcium ions and drugs in blood circulation. Albumin solution is used as a volume expander in emergency situations like shock, burns or massive blood loss. Albumin can be heated-treated to inactivate viruses and is widely used for various therapeutic indications.
Immunoglobulins
Immunoglobulins or antibodies are Y-shaped proteins produced by plasma cells that recognize and neutralize pathogens. There are five main types of antibodies – IgG, IgA, IgM, IgD, and IgE. IgG is the most abundant type accounting for about 75% of total serum antibodies. Therapeutic immunoglobulins derived from plasma are prescribed for treating a variety of immune disorders. Intravenous immunoglobulin preparations find major application in treatment of immunodeficiencies and autoimmune diseases.
Coagulation Factors
Blood clotting or coagulation is a complex process involving several plasma proteins called clotting factors. Some of the important clotting factors isolated for therapeutic use include Factor VIII (used for treating Hemophilia A), Factor IX (for Hemophilia B), prothrombin complex concentrates (for treating Warfarin side effects) and Von Willebrand Factor. Plasma-derived clotting factor concentrates are administered to patients with clotting factor deficiencies and bleeding disorders. However, they carry risk of transmitting infections and recombinant alternatives are preferred now.
Other Plasma Proteins
Apart from the major blood plasma derivatives discussed above, several other important plasma constituents are fractionated for clinical and research applications. Alpha-1-proteinase inhibitor is used for treating alpha-1 antitrypsin deficiency. Antithrombin III is indicated for patients undergoing high-risk surgery or with hereditary antithrombin deficiency. Plasminogen concentrates are prescribed for treating plasminogen deficiency and lysosomal storage disorders. Fibrinogen and thrombin are used during surgeries for helping clot formation.
Viral Inactivation and Safety
Since plasma derivatives are sourced from pooled human donations, there is risk of transmitting infectious viruses. So stringent processes are followed during plasma collection, fractionation and viral clearance steps. Various methods used are nanofiltration, solvent/detergent treatment, heat treatment and incubation. Also donor screening and testing ensures high safety. Today’s plasma derivatives have negligible risk of transmitting infectious diseases like HIV, hepatitis and others. However, there is still a theoretical risk of transmission of unknown or emerging pathogens.
Regulation of Plasma Industry
Being biological products sourced from human blood, blood plasma derivatives are closely regulated by agencies like the FDA in US and EMA in Europe. Regulations cover donor eligibility, plasma collection standards, manufacturing and quality compliance, viral safety validation, adverse reaction monitoring and record maintenance. Only licensed and GMP certified plasma fractionation facilities following prescribed cGMP standards are authorized to produce plasma components for therapeutic use. Strict national and international regulations have ensured high quality and safety of plasma derivatives used worldwide.
Future of Plasma Therapeutics
With growing needs of plasma derived medications, the plasma collection sector is expanding rapidly. Advanced technology facilitate high yield fractionation of novel plasma components. Recombinant techniques may substitute few plasma products. But plasma will likely remain major source to manufacture certain critical drugs in years to come. More plasma sources like umbilical cord blood are being explored. Coming together of technology, innovation and strict governance will further cement the role of blood plasma derivatives as life-saving therapeutics.
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1.Source: Coherent Market Insights, Public sources, Desk research
2.We have leveraged AI tools to mine information and compile it
