Human Plasma
Human Plasma is a light amber-coloured liquid component of the blood rich in proteins. It mostly contains 95% water and 6-8% important dissolved proteins like serum albumins, globulins, fibrinogen, clotting factors, electrolytes, hormones etc. It plays a vital role in maintaining an intravascular osmotic effect that keeps electrolyte concentration balanced and protects the body from infection and other blood-related disorders.
Plasma Collection & Testing
At Hetero, we take pride on being at the forefront of plasma collection and management, ensuring safety, quality and the highest standards throughout the process. Our commitment to excellence has earned us the distinction of being granted permission by the Drug Controller General of India (DCGI) to collect human plasma from blood banks across the nation.
Our extensive network of licensed Blood Banks undergoes rigorous audits to meet stringent safety and quality criteria. This commitment to excellence allows us to source the highest quality of recovered plasma, setting us apart as pioneers in the field. Human plasma being a rare commodity, Hetero is dedicated to ensure that every unit of plasma collected is used by adhering to the highest standards of manufacturing process producing lifesaving Plasma derived medicinal products (PDMPs), contributing to the well-being of our communities
Our dedicated plasma testing team in Hetero ensures the viral safety of the collected plasma by testing and screening the plasma bags for HBsAg, HIV I & II antibodies, HCV antibodies by serology/ CLIA and HCV RNA, HIV RNA, HBV DNA by NAT (Nucleic Acid testing) before the plasma is released for manufacturing. This ensures that every bag of plasma entrusted to us is utilized optimally for manufacturing.
Manufacturing Process
The transformation of plasma into therapeutic products is a complex process. At Hetero, recovered plasma will be fractionated and purified to different life saving therapies using state-of-the-art hybrid technology, using Cohn’s fractionation process and Chromatography methods, in a cGMP Plasma fractionation facility.
The manufacturing procedures incorporate orthogonal virus inactivation/removal steps, which inactivate potential viruses, further ensuring product safety. The technical team is trained, experienced and strives to maintain the highest quality throughout the manufacturing process. Our consistent focus throughout the operational process enables us to produce a safe, robust and efficient plasma therapy product.