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- W1692666938 abstract "The field of cell-based medicines is moving fast from research and development toward translation into therapeutic treatment options. Correspondingly, the manufacture raises highest demands with respect to sterility and quality of the finished product. On its way from bench-to-bedside, the production process of such advanced therapy medicinal products (ATMPs) must, therefore, finally comply with the principles of Good Manufacturing Practice (GMP). This concept implements quality standards to ensure product consistency and the most possible patient safety. Accordingly, the chapter delineates several guidelines and regulations with relevance for the manufacture of cell-based ATMPs. It provides guidance for their respective interpretation and targets the key elements of a GMP-compliant environment. Moreover, the interrelated structure of its single components is exemplified." @default.
- W1692666938 created "2016-06-24" @default.
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- W1692666938 date "2016-01-01" @default.
- W1692666938 modified "2023-10-16" @default.
- W1692666938 title "Good Manufacturing Practice Compliance in the Manufacture of Cell-Based Medicines" @default.
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- W1692666938 doi "https://doi.org/10.1016/b978-0-12-803115-5.00004-8" @default.
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