Abstract
We previously described and characterized a highly standardized and clinical grade human platelet lysate (hPL). We also demonstrated that it constituted a powerful substitute for fetal bovine serum (FBS) for human mesenchymal stem cell (hMSC) expansion required in cell therapy procedures, avoiding xenogenic risks and ethical issues. Even if hPL is manufactured from controlled platelet concentrates released by blood transfusion centres, the recently published general chapter 5.2.12 of the European Pharmacopeia requires the addition of a step of viral inactivation during the production process of such raw material of biological origin used for cell-based and gene therapy medicinal products.
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