Advanced Therapy Medicinal Products (ATMPs) are a particularly challenging medicinal product class with specific regulations. One particular challenge lies in the design of production. Moreover, the starting materials vary and regulations are tight, in terms of the quality assessment and release criteria necessary for ATMPs. New scientific insights and increased understanding of immunological and biological functions encourage development of novel ATMPs, and increase the need for understanding the regulatory requirements and the path forward from bench to bedside.
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