Fraunhofer Institute for Cell Therapy and Immunology IZI
GMP Development
The GMP Development Unit converts highly manual academic laboratory procedures into GMP-compliant manufacturing processes to obtain official manufacturing authorization for the production of clinical trial samples, including (semi-)automated equipment and solutions.
We also have extensive knowledge and experience in the establishment and optimization of new analytical methods (e.g. cytotoxicity or efficacy assays) and the documentation and evaluation of all manufacturing- and quality-related data under GMP-like conditions.
Main competencies
GMP process design, optimization & automation
- Feasibility studies & tests of equipment and individual process stages
- Process design & adjustment (e.g., increase in production scale)
- Progression of academic laboratory procedures into GMP manufacturing processes
- Consulting on the selection of raw and starting materials incl. procurement
- Reduction of manual process steps for faster and automated production
Implementation and development of quality controls
- Automated performance of standard cell analyses (e.g., cell count, viability, metabolites)
- Molecular and cellular phenotyping of the desired target cells (e.g., ddPCR, flow cytometry)
- Development of IND-specific cytotoxicity and potency assays
- Consultation on regulatory requirements
GMP training
- Specialized trainers with hands-on experience in GMP manufacturing of cell and gene therapies (e.g., CAR-T cell therapies)
- GMP basic training, courses for good documentation and sterile work in the laboratory
- Customized training courses on the basics of GMP production of cell and gene therapies