Plasma-derived therapies are a diverse group of life-saving medications produced from human plasma, the liquid portion of blood that contains essential proteins such as antibodies, clotting factors, and albumin. These therapies are created through a process known as fractionation, where donated plasma—typically collected by plasmapheresis—is separated, purified, and subjected to rigorous viral inactivation and testing. This ensures that the final products are safe and effective for clinical use.
What They Are
Plasma-derived therapies encompass a wide range of medicinal products. At their core, they are biologic medications extracted from human plasma. Plasma itself represents about 55% of the total blood volume and is rich in proteins that play vital roles in immune defense, blood clotting, and maintaining blood volume. The manufacturing process involves collecting plasma from healthy donors via plasmapheresis, a procedure in which plasma is separated from blood cells—often returned to the donor—while the plasma is frozen and later processed. This process yields purified components such as immunoglobulins, clotting factors, albumin, and specialized inhibitors, each tailored for specific therapeutic applications.
How They Are Used
These therapies have broad clinical applications and are administered based on the particular needs of the patient. Immunoglobulin replacement therapy is used to provide passive immunity for individuals with primary or secondary immunodeficiencies, as well as autoimmune conditions. It involves either intravenous (IVIG) or subcutaneous (SCIG) administration to supply essential antibodies that help fight infections and regulate immune responses. Clotting factors are critical for patients with bleeding disorders such as hemophilia A and B or von Willebrand disease, as they restore the body’s ability to form blood clots and control bleeding. Additionally, hyperimmune globulins—which are concentrated immunoglobulins from donors with high antibody titers against specific pathogens—are employed post-exposure to treat conditions such as rabies, tetanus, and hepatitis B.
Benefits of Plasma-Derived Therapies
Plasma-derived therapies offer significant benefits across a spectrum of medical conditions. They provide life-saving treatment options for patients with rare and severe disorders, often representing the only effective therapy available. Their targeted nature allows for personalized treatment, as each product is designed to address a specific deficiency or dysfunction. The rigorous manufacturing processes ensure a high level of safety and efficacy, making these biologics reliable in critical clinical scenarios. Furthermore, plasma-derived therapies play a crucial role in stabilizing patients during acute medical emergencies—such as shock, severe burns, or during major surgeries—by restoring blood volume and essential proteins. Finally, the sustained plasma donation programs support a continuous and renewable supply of these therapies, which is critical for managing chronic conditions over a patient’s lifetime.
Plasma-derived therapies thus remain a cornerstone of modern medicine, delivering targeted, safe, and effective treatments that save lives and enhance the quality of life for countless patients around the world.
IVIG Therapies
Intravenous Immunoglobulin (IVIG) therapies are vital for patients with immunodeficiencies, autoimmune disorders, and other immune-related conditions, as they deliver concentrated antibodies to bolster the immune system, fight infections, reduce inflammation, and restore balance. These treatments provide immediate passive immunity, crucial for individuals with compromised defenses, while also mitigating autoimmune reactions. Our resources offer in-depth insights into the advanced science and rigorous manufacturing practices—featuring state-of-the-art analytical testing and innovative process development—that ensure each IVIG product meets the highest standards of safety and efficacy, ultimately safeguarding patient health.
Discover our IVIG capabilities and see how our advanced analytical testing and innovative process development ensure the highest standards in safety and efficacy.
Click here to explore our comprehensive solutions that make life-saving IVIG therapies a reality.
Clotting Factors
Clotting factors are essential proteins isolated from human plasma that play a critical role in the blood coagulation cascade and are used to treat bleeding disorders such as hemophilia A and B, where deficiencies in Factor VIII or Factor IX lead to uncontrolled bleeding, as well as von Willebrand disease, which affects platelet adhesion. These specialized proteins work sequentially to form stable clots at injury sites, and their production begins with the collection of plasma from healthy, screened donors via plasmapheresis. The plasma then undergoes fractionation—using techniques like ethanol precipitation, chromatography, and filtration—to isolate individual clotting factors at high purity, with multiple viral inactivation and removal steps (such as solvent-detergent treatment, pasteurization, and nanofiltration) ensuring safety. Regular prophylactic infusions of these high-purity concentrates have transformed the management of bleeding disorders by reducing complications and improving quality of life while minimizing the risk of transmitting infectious diseases.
Our advanced bioanalytical services precisely measure clotting factor activity to ensure your plasma-derived therapies meet the highest quality standards, while our expert team supports treatment refinement and product optimization
Visit our Clotting Factors page today to learn more about our advanced bioanalytical solutions