Plasma is a clear, yellowish liquid component of human blood that is generally 50-60% of the volume. Cells and a variety of substances vital to the human body are carried throughout the body in plasma. It contains water, salts, enzymes, antibodies, and other proteins. The substances carried in plasma are critical to fighting diseases, and therefore,essential for maintaining health.

Plasma contains numerous proteins which are required for the body to function properly. Important plasma proteins include:
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Plasma-derived medicines (also often referred to as plasma-derived medicinal products [PDMPs]) are medicines made from donated plasma. These therapies are used to treat people with rare, chronic, and life-threatening conditions. Examples are treatment of shock and burns, inability to fight infection, inability to form a clot to stop bleeding. Manufacturing plasma-derived medicines is a lengthy, complex, and highly regulated process which can take up to one year.

These unique therapies treat a variety of chronic and life-threatening medical conditions, many times caused by insufficient levels of any one plasma protein. Medicines created from donated plasma are sometimes used as a sole treatment or in combination with other treatments to support a variety of medical needs. Some conditions include:
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Plasma-derived medicines are critical because they replace or supplement essential human proteins that the body cannot make on its own — or cannot make in sufficient amounts — when people are sick, injured, or genetically unable to do so. For many patients, there is no alternative therapy.

The production of plasma-derived medicines begins with donated plasma from healthy individuals. Plasma donations are pooled, and then individual proteins are extracted through a complex and highly-regulated process called fractionation.

The production of plasma-derived medicines is strictly regulated by competent authorities, but the industry’s dedication goes even further. Additional safety measures and standards are implemented to protect donors and ensure their well-being. Every plasma donation undergoes rigorous testing for quality and safety. Advances in testing technologies help ensure plasma safety while meeting regulatory standards efficiently. Plasma from thousands of donations is pooled to achieve the large-scale volumes needed for manufacturing. This step ensures consistency in the final product, reflecting the global collaboration required to meet clinical need.

Using specialized techniques, the pooled plasma is separated and purified, and each protein undergoes advanced processes to ensure therapeutic safety. Innovations in purification techniques continue to enhance efficiency, ensuring these lifesaving medicines meet the highest safety and quality standards. Multiple safety protocols, including heat treatment, nanofiltration, and solvent/detergent treatment, are employed to inactivate or remove viruses. These measures safeguard against known and emerging pathogens, supporting the trust and reliability of plasma-derived medicines worldwide. Purified proteins are formulated into therapies like intravenous immunoglobulin (IVIG) or clotting factor concentrates and filled into sterile vials or other methods of administration. Continuous engagement with regulatory bodies helps assure efficient and safe approval processes, ensuring timely access for patients.

Unlike simple blood donation, plasma is collected through a process called plasmapheresis. A needle is placed into a vein in the arm and connected to a plasmapheresis machine which removes whole blood, separates the plasma from the other blood components, and then returns those components to the donor.

Donating plasma is a very safe process that is highly regulated. To ensure the plasma donor safety and ensure uniform, high-quality standards for collection practices, PPTA developed the International Quality Plasma Program (IQPP), which is a global quality and safety standards program. The IQPP requirements often go beyond national regulations and ensures plasma collected around the world meets the same high standards.

Plasma collection centers follow strict donor eligibility, monitoring, and safety standards, including trained staff, medical oversight, and post-donation care. Plasma donation is similar to blood donation in several important ways, especially when it comes to donor safety, screening, and the types of experiences donors may have. Plasma donation adverse events are generally similar to those seen in whole blood donation, and most are mild, temporary, and manageable.

The International Quality Plasma Program (IQPP) protects donors and patients by focusing on donor health while ensuring plasma quality for patients who rely on plasma-derived medicines. IQPP is a rigorous, voluntary program that goes beyond regulatory requirements to help ensure donor safety and further improve the quality of source plasma used for fractionation.

Plasma donation requirements are designed to protect donor health and ensure patient safety. While details can vary slightly by country and collection center, the core requirements are similar worldwide. Donors are considered eligible to donate plasma after completing a successful pre-donation health assessment which includes a brief physical examination and answering medical history questions. Protein and hemoglobin levels are evaluated before each donation. Contact your local plasma donation center to learn more about the eligibility process.

While plasma regenerates quickly in the body and red blood cells are returned to the donor during donation, donation frequency is set to protect the long-term health of the donor. The frequency of plasma donations is regulated by national health authorities. Before each donation, donors must meet eligibility requirements, pass health screenings, and have adequate protein levels.