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Center of expertise for ATMP

Through the Center of Expertise, developers of ATMP are supported to bring their advanced products to the clinic.

The translation from pre-clinical research with ATMP to clinical application in patients requires extensive knowledge regarding regulatory issues (types of permits required and procedures for obtaining them) and many aspects in relation to the preparation of these medicines (GMP-compliant quality system, clean room facilities, SOP's and product documentation (IMPD) etc.

Specific knowledge and experience regarding the production process of an ATMP or study with an ATMP is often absent with researchers. The constantly renewing regulation is difficult to understand. For most researchers the understanding of these regulations does not have priority.

Through the Center of Expertise, developers of ATMP are supported to bring their advanced products to the clinic. Researchers are supported during the preparatory phase preceding the clinical study. The Center of Expertise helps to navigate through the regulatory framework, to prepare the ATMP-specific dossier including the investigational medicinal product dossier and to obtain the required permits for the production and clinical application of the ATMP. In addition, researchers are assisted with the translation of the research production protocol into a GMP-compliant production protocol. This includes the upscaling of the procedure, the replacement of research grade ingredients with GMP compliant ingredients and the transition of an open production system into a closed production system, when possible. We also advise on the design of in process quality controls and the specification of the release criteria of the final ATMP product.