Cell Therapies Development & Clinical Manufacturing
Evotec Modena, a state-of-the-art GMP manufacturing facility located in the heart of Europe’s most prominent Biomedical District, stands as a beacon of innovation and excellence in the field of cell and gene therapy. Founded in 2009 as a spin-off from the University of Modena and Reggio Emilia, and acquired by Evotec in 2022, the facility is equipped to handle complex therapeutic projects from early development through to clinical manufacturing. Evotec Modena stands out for its dedication to innovation and research in the field of cell therapy. With a focus on therapeutic areas such as diabetes and oncology, Evotec Modena’s R&D platform is at the forefront of developing revolutionary treatments.
Our Special Capabilities
State-of-the-Art GMP Manufacturing Facility
- Facilities designed to support multiple projects at varying stages of development, with clean rooms covering more than 1200 m²
- Accredited by the Italian Authority for the manufacturing of clinical stage cell therapies.
- Experienced in the production and testing of MSCs, TILs, CAR-T cells, iPSC, Autologous and Allogeneic products.
Comprehensive iPSC-based, Autologous and Allogeneic Therapeutics Manufacturing Experience with a Continuous Quality and Regulatory Strategic Control
- Pre-GMP lab and GMP cleanroom design for developing robust manufacturing strategies
- Capabilities include expansion, scale-up, GMP-compatible bioreactor platforms, and analytical development and release
- Streamlined transition from early development, through pre-GMP process development, to full-scale GMP manufacturing
- Development of GMP-compliant procedures, tox batch supply, QC validation, and clinical batch production
- Additional capabilities for Gene Editing and Genetic Integrity
- Quality assurance and regulatory compliance throughout all stages guarantee by our internal dedicated departments
Quality Control Laboratory
- Equipped to perform a variety of authorized tests including cell viability, identity, purity, cytotoxicity, and ELISA tests.
- Advanced capabilities such as automated count and viability, microscopic evaluation, PCR, and several additional tests.
