Fraunhofer Institute for Cell Therapy and Immunology IZI
GMP Biopharmaceuticals
In recent years, the increasing number of biopharmaceuticals under preclinical and clinical development have required new flexible, efficient, and economic opportunities for GMP production of therapeutic antibody candidates. Small-scale batch production of test samples for late preclinical GLP animal studies or for phase-1 and phase-2 clinical studies is often not appropriate for large-scale manufacturing facilities in the industry. The Fraunhofer IZI, founded in 2005, investigates and develops solutions to such specific problems at the interfaces of medicine, life sciences and engineering.
The group has a completely qualified GMP antibody production facility. Our facility has a size of 180 m² and involves all clean room classes from D to A. The use of single-use equipment and materials enables an easy adaption to new process requirements. The GMP facility can be used for different contract manufacturing processes for preclinical and clinical (Phase 1/2) test samples as well as for process or instrument validation projects under consideration of special customer requests. The standard equipment can be easily broadened for new products.
In summary the main advantages are:
- high flexibility
- easy switch to different products
- fast implementation of technology changes
- customized production
- ideal batch size for preclinical and early clinical trials
- possibility to obtain ready-to-use GMP-compliant products by the integrated sample filling
Future projects could include:
- transferring promising biopharmaceutical candidate from research to clinical development
- designing a user-specific process with single-use materials
- GMP-compliant production of recombinant proteins in 200-L scale