Fraunhofer IZI is strategic partner of CREATIC in particular for the research and development of cell and gene therapies paired with expert training and exchange.
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 of 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 the developments in immuno-oncology and infectious disease pathology. The on-site S3 safety laboratories allow to conduct research and development activities and to investigate highly pathogenic agents 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.
The following highly relevant expertise and experience of Fraunhofer IZI will help CREATIC to move forward towards its 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 to 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 and automation
- Implementation and development of quality controls
- Testing and optimizing new devices, products and processes in compliance with GMP regulations
GMP manufacturing of cell and gene therapeutics and biopharmaceuticals
- More than 17 years of 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
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
