Department of GMP Cell and Gene Therapy

The Department of GMP Cell and Gene Therapy operates Fraunhofer IZI's two modern GMP facilities consisting of six separate clean room suites (altogether 13 clean room grade B manufacturing rooms) which have been specially optimized for manufacturing of cell and gene therapy products, so called Advanced Therapy Medicinal Products – ATMP. The particular specialty of the about 110 highly qualified staff members is the GMP-compliant manufacturing and quality control of investigational medicinal products.

Both the transfer planning and the establishment of GMP-compliant processes and quality controls, as well as the creation of project-specific documentation in accordance with Chapter 6 of the EU GMP Guidelines Part 4: Guidelines for Good Manufacturing Practice for Advanced Therapy Medicinal Products (ATMPs) are discussed in detail with the project partner at the start of the project and then implemented in practice to a high standard of quality. The leading staff in charge has many years of experience in designing GMP-processes in the cell therapy area.

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To date, more than 4500 autologous and allogeneic cell products have been released for clinical use since 2006, including 700 different autologous CAR-T cell products and CAR-T intermediate products.

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In addition to regular client inspections, the department successfully passed 14 inspections by Local and Higher Federal Authorities.

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