June 17, 2024
Blood Plasma Derivatives

Blood Plasma Derivatives: Life-Saving Products Developed from Human Plasma

It carries cells and proteins throughout the body and enables clotting to stop bleeding. Plasma derivatives are medicinal products that are extracted and purified from donated human blood plasma through intricate manufacturing processes. Blood plasma derivatives, also known as plasma proteins, are used globally to treat immune deficiencies, bleeding disorders, infections and other serious medical conditions.

Immunoglobulins

One of the most well-known plasma derivatives are immunoglobulins, also known as antibodies. Produced by plasma B cells, immunoglobulins help the body fight infections by identifying and neutralizing bacteria and viruses. Blood Plasma Derivatives Intravenous immunoglobulin (IVIG) products extracted from pools of thousands of plasma donations are administered to patients with immune deficiencies that prevent them from producing sufficient antibodies. IVIG treatment can help manage chronic inflammatory demyelinating polyneuropathy, HIV/AIDS, Kawasaki disease and other immunodeficiency conditions. Subcutaneous immunoglobulin preparations are also available for home infusion therapy.

Coagulation Factors

Bleeding disorders occur when the blood is unable to clot properly due to deficiencies in clotting factors, which are serum proteins essential for hemostasis. Plasma derivatives are used as replacement therapies for patients with hemophilia and other rare bleeding disorders. For example, hemophilia A is caused by a deficiency in factor VIII, so treatment involves intravenous administration of recombinant or plasma-derived factor VIII concentrates. Similarly, factor IX concentrates are used for hemophilia B and factor VIIa for hemophilia with inhibitors. By replacing the missing clotting factor, these blood plasma derivatives enable normal blood clotting.

Alpha-1 Proteinase Inhibitor

Alpha-1 proteinase inhibitor (A1-PI) is a serine protease inhibitor synthesized in the liver. In people with genetic A1-PI deficiency, the inhibitor is not present in sufficient amounts to protect lung tissue from destruction by neutrophil elastase. Plasma-derived A1-PI augmentation therapy helps slow the progression of emphysema caused by A1-PI deficiency. Weekly intravenous infusions of purified human A1-PI from plasma stabilize lung function and improve patients’ quality of life. Prolastin-C and Aralast NP are two commercial plasma therapies approved for this progressive lung disease.

Albumin

Albumin is the most abundant protein found in blood plasma and helps maintain oncotic pressure of the blood vessels. Low albumin levels can result from conditions like liver disease, malnutrition or sepsis. Plasma-derived albumin is administered intravenously to expand blood volume in emergencies or during surgery. It is also used for prevention of alanine-induced encephalopathy in certain liver diseases. Albumin’s properties as a nutrient and transporter of medications, metabolites and hormones make it valuable for clinical indications including hypovolemia, ascites, hypoproteinaemia and hypoalbuminemia.

Other Plasma Proteins

In addition to the main plasma derivatives discussed above, purification technology has enabled production of numerous other medically essential proteins from donated human plasma. Anti-inhibitor coagulation complex treats hemophilia patients with factor VIII or IX inhibitors. Antithrombin III helps control coagulation and is given for hereditary antithrombin deficiency or during surgery. Fibrinogen concentrate is a haemostatic agent used for congenital fibrinogen deficiencies or massive hemorrhage. Thrombin (activated factor II) speeds up clotting. Thromboplasmin is used diagnostically as a thromboplastin reagent. The diversity of plasma derivatives highlights their life-saving role across many therapeutic areas.

Manufacturing and Regulation

The intricate manufacturing process for plasma derivatives involves plasma collection from FDA-approved plasma donation centres, virus inactivation/removal steps, protein fractionation, viral reduction filtration, and high-level purification through techniques like chromatography. Final products are filled into sterile vials or bags and undergo extensive safety and efficacy testing before release. Strict regulations from agencies like the FDA and EMA ensure plasma collection and production adhere to the highest quality standards for safety, purity and potency. Ongoing pharmacovigilance also monitors derivatives for adverse reactions. Together, these measures maximize benefits and minimize risks to patients relying on plasma therapies.

Future Advancements

Continued research seeks to develop new plasma fractions and improve current manufacturing efficiency. Monoclonal antibody purification directly from plasma may soon substitute for traditional cell culture methods. Gene therapy holds promise for conditions currently treated by plasma replacement. But plasma derivatives will likely remain necessary given their superior efficacy versus synthetic substitutes for many applications. Areas of focus include increasing global plasma collection, enhancing fractionation technology, expanding fraction capabilities, streamlining viral safety processes and facilitating worldwide patient access through cooperative programs. Overall, steady progress in basic research and manufacturing supports an encouraging future for life-saving plasma therapies.

In summary, blood plasma derivatives extracted from human donor plasma through advanced technology currently provide essential treatment globally for immune deficiencies, bleeding disorders, infections and other serious conditions. Their production involves intricate manufacturing guided by stringent regulations to ensure safety, purity and potency. Ongoing advancements aim to develop new plasma fractions, improve production and facilitate worldwide access. Plasma derivatives play a critical role in modern medicine as life-saving therapeutics to help patients who would otherwise face severe disability or even death without these vital protein replacement therapies.

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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