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Infrastructure & Services

 

Infrastructure and Services

GMP - Manufacturing of advanced therapy medicinal products (ATMP)
Through the flexible design, the facility is especially attractive for biotechnology companies that seek to bring newly developed cell-based medicinal products into clinical application via clinical trials. The facility is divided into different independent suites. Each has its own grade C clean rooms (preparation), own air locks from grade C to B (personnel and materials transport) and two grade B rooms (aseptic manufacturing). The clean room grade A is provided via laminar airflow cabinets that are installed in the B-rooms. The available clean room suites are specialized for processes associated with manufacturing of human autologous or allogeneic cell-based therapeutics (e. g. tissue engineering products, stem cell preparations, cancer vaccines, gene therapeutics). Besides the clean rooms and the technical and, respectively, regulatory infrastructure, the Fraunhofer IZI offers assistance for the set-up and validation of GMP-compliant manufacturing processes as well as for obtaining a manufacturing authorization according to §13 of the German Drug Act.

Services Offered

  • GMP-compliant process development
  • set-up, validation and performance of GMP-compliant quality controls
  • GMP manufacturing of different cell-based therapeutics (autologous and allogeneic cell-based therapeutics, e.g. tissue engineering products, adult stem cell preparations, cancer vaccines, gene therapeutics)
  • consultancy services in regard to design and validation of GMP-compliant manufacturing processes
  • support for obtaining an official manufacturing authorization according to §13 German Drug Act
  • transfer of projects from research and development to a GMP-compliant level
  • manufacturing and cryo-preservation of master and working cell banks

Head of GMP Facility
Dr. Gerno Schmiedeknecht
Tel: +49 (0) 341 355 36-9705
Email: gerno.schmiedeknecht@izi.fraunhofer.de
Internet:http://www.izi.fraunhofer.de/izi_gmp.html

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