The Fundamental Role of Chromatography in the Large Scale Manufacture of Plasma-Derived Medicinal Products

Abstract Plasma-derived medicinal products (PDMPs) are valuable group of medications which are used for prevention, control and treatment of several life-threatening diseases. Today, due to the increasing demand for PDMPs, the industrial scale production of these medicinal products has modified from those mainly based on cold ethanol fractionation, to combined consecutive processes including cryoprecipitation, ethanol fractionation, chromatographic procedures and pathogen reduction methods. However it has been proved that the implementation and combination of selective and specific chromatographic procedures in the plasma fractionation industry will be accompanied by main advantages such as improvement of product purity, safety, and quality, optimization of protein recovery, increasing the diversity of plasma products, removal of unwanted compounds and improvement of cost-effectiveness of plasma processing. Thus in this review some of the upstream or downstream applications of chromatographic procedures in extraction, isolation, purification, manufacture and analysis of Plasma-derived medicinal products will be briefly discussed.

Key words: Chromatography, Fractionation, Manufacture, Plasma-derived medicinal products.

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Updated: January 20, 2024 — 8:37 am