GMP Facility

GMP Facility
Through the flexible design, the facility is especially attractive for new biotechnology companies that seek to bring newly developed active ingredients and 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. Most of 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). One suite is designed for the manufacturing of therapeutic recombinant proteins and antibodies in small scale (for phase I to early phase II trials).
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 AMG.

Services Offered

• GMP-compliant process development
• GMP manufacturing of different cell-based therapeutics (autologous and allogeneic cell-based therapeutics, e.g., tissue replacement/tissue engineering products, adult stem cell preparations, cancer vaccines, gene therapeutics)
• GMP manufacturing of biologicals based on mammalian cells for phase I or early phase II clinical trials (e.g. therapeutic recombinant glycoproteins and monoclonal antibodies)
• provision of a qualified person according to §14 AMG
• consultancy services in regard to design and validation of GMP-compliant manufacturing processes
• support for obtaining an official manufacturing authorization according to §13 AMG
• provision of separate clean room suites for manufacturing of pharmaceutical products
• transfer of projects from research and development to a GMP-compliant level
• manufacturing, cryo-preservation and storage of master and working cell banks

^{Source: http://www.izi.fraunhofer.de/izi_gmp.html?&L=1}

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