Fraunhofer IZI
Fraunhofer IZI is strategic partner of CREATIC for the R&D of cell and gene therapies.
The Fraunhofer Institute for Cell Therapy and Immunology IZI investigates and develops solutions to specific problems at the interfaces of medicine, life sciences and engineering. One of the institute‘s main tasks is to conduct contract research for companies, hospitals, diagnostic laboratories and research institutes operating in the field of biotechnology, pharmaceuticals and medical engineering.
The Fraunhofer IZI develops, optimizes and validates methods, materials and products within the business fields cell and gene therapy, drugs and vaccines, molecular diagnostics and immunodiagnostics, as well as extracorporeal therapies. Its areas of competence lie in cell biology, immunology, drug biochemistry, bioanalytics and bioproduction as well as process development and automation. Research in these areas is centered around developments in immuno-oncology and infectious disease pathology. The S3 safety laboratory allows research and development activities to be conducted and highly pathogenic agents investigated under biosafety level 3 conditions.
The institute works in close cooperation with hospital institutions and performs quality tests besides manufacturing investigational medicinal products in line with GMP requirements. Furthermore, it supports partners in developing processes for the pharmaceutical production of ATMPs and biologicals, for example by helping them to obtain manufacturing licenses.
Most important expertise and experience of Fraunhofer IZI, which helps CREATIC to move forward towards to our goals.
Research & Development
- Cell and gene therapy design
- Experience with various effector cell types (T-Cells, NK-Cells, and Macrophages)
- Experience with viral and non-viral gene modification methods
Preclinical development
- in vitro and in vivo testing (efficacy and safety) of drugs as well as ATMPs according GLP
- Cell analysis, assay development and diagnostics
- modern animal testing facility, numerous models established, development of customized disease models
GMP process development and up-scaling
- GMP process design, optimization & automation
- Implementation and development of quality controls
- Testing and optimizing new devices, products and processes In terms of GMP capability
GMP manufacturing of cell and gene therapeutics and biopharmaceuticals
- More than 17 years experience in GMP manufacturing of cell based therapeutics
- 3,500 released products for clinical applications (incl. ~500 CAR T Cell Products)
- Modern clean room infrastructure and well trained staff