Plasma-derived Medicinal Products
Recommendation
Thursday, 25 April 2024 11.00 - 18.00 h
Suitable analytical methods to assess AAV quality during development and manufacturing
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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.
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