11 August 2020
Human plasma contains many proteins which, following extraction, purification, and formulation into medicinal products are of great medical importance. Plasma-derived products provide life-saving therapies but the quantity of plasma for fractionation is limited by the number of donors. Therefore, the exchange of intermediates between manufacturers or the use of a variant manufacturing process (see below) may be possible to assure the best use of blood/plasma donations.
The Guideline on plasma-derive medicinal products provides guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products. Specific attention is given to the virus safety of these products.