Plasma Fractionation

What is Plasma Fractionation?

Plasma fractionation is a specialized biotechnological process used to extract vital therapeutic proteins from human plasma, the liquid component of blood. These proteins include:

• Human Serum Albumin (HSA)
• Immunoglobulins (IgG, IgM, IgA)
• Coagulation Factors (Factor VIII, Factor IX)
• Protease Inhibitors
• Monoclonal Antibodies (mAbs)

These components play a critical role in treating life-threatening and chronic medical conditions, making plasma fractionation an essential part of modern healthcare.

A Legacy of Innovation

First developed during World War II to produce serum albumin for treating shock and burns, the field has since evolved through innovations in cold ethanol fractionation, chromatographic purification, and viral inactivation methods. Today, plasma fractionation is at the intersection of biotechnology, transfusion medicine, and pharmaceutical manufacturing.

Applications of Plasma-Derived Medicinal Products (PDMPs)

PDMPs are life-saving biologics used in a wide range of medical applications:

• Hemophilia Treatment – Factor VIII, Factor IX
• Primary Immunodeficiency Therapies – Intravenous (IVIG) & Subcutaneous (SCIG) Immunoglobulins
• Autoimmune & Neurological Disorders – Guillain-Barré Syndrome, Myasthenia Gravis
• Post-Exposure Prophylaxis – Hyperimmune globulins for hepatitis B, rabies, tetanus
• Volume Expansion – Albumin for trauma, burns, hypoalbuminemia
• Specialty Uses – Rh(D) Immune Globulin, α1-Antitrypsin, Antithrombin III, C1-Esterase Inhibitor, Fibrin Sealants

These therapies are indispensable in managing conditions that would otherwise lead to significant morbidity or mortality.

Our Vision: World-Class Plasma Fractionation Facility

We are establishing a state-of-the-art Human Plasma-Derived Medicinal Products (HPDMP) manufacturing facility with an initial annual capacity of 250,000 liters, scalable to 500,000 liters. Our facility is designed to:

• Deliver high-purity, safe, and effective PDMPs
• Ensure regulatory compliance and GMP standards
• Support India's self-reliance in critical blood-plasma products
• Advance research in monoclonal antibodies (mAbs) and novel therapeutics