Classification and Regulation of Advanced Therapy Medicinal Products

Advanced therapy medicinal products (ATMPs) represent a group of innovative pharmaceuticals that are increasingly gaining importance. It combines gene therapeutics, somatic cell-based products and tissue-based products. ATMPs are often produced in small batches for personalised therapies only. These therapies are particularly important for severe, untreatable or chronic diseases for which conventional approaches have proven to be inadequate. Tatjana Buchholz and Martin Schleef at PlasmidFactory say that the manufacturing process of the ATMPs is mostly still in development.

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