End-to-End Platform Overview
Full Integration Under One Roof
Evotec provides all relevant technologies and infrastructure, in addition to broad expertise and an experienced scientific team, to jump start and speed-up the development of a new class of cell therapies with the potential to cure multiple diseases. This involves all steps from research to development up to clinical testing of cell therapy product candidates in patients. Thus, it comprises an end-to-end integrated process flow from project inception to the clinic, including cell differentiation, upscaling, GMP gene editing and manufacturing.
In addition to manufacturing clinical material, Evotec, through its teams at the Modena and Verona sites, provides regulatory support from the development phase up to market entry, as well as clinical CRO services.
Gene Editing Process for Targeted Engineering
We have a process in place for highly efficient nuclease-based gene editing at the iPSC stage. This includes a quality control (QC) workflow with specific protocols, e.g., extensive genetic testing, to ensure genomic integrity, prior to selecting an iPSC clone for master cell bank (MCB) generation.
Gene editing can also be performed in a GMP environment and in a GMP compliant manner.
Immune Cloaking & FailSafe as Key Enabling Technologies
To create safe, immune-compatible iPSC-derived cell therapy products, we utilize in-licensed and proprietary state-of-the-art methods. Immune cloaking technology blocks the response pathways for key immune cells thus allowing the use of off-the-shelf cell products without immunosuppression.
As an additional safety feature, we can apply Fail-SafeTM technology (licensed from panCELLa)- a drug-inducible kill switch allowing to selectively eliminate unwanted dividing cells.
State-of-the-Art GMP Manufacturing
Evotec’s Modena site serves as a center of excellence for cell therapy manufacturing. The facility specializes in state-of-the-art cGMP manufacturing, including the production of clinical material for iPSC-derived therapies and other allogeneic and autologous therapies such as MSCs, TILs, CAR-T cells, and dendritic cells. The site offers pre-GMP development, optimization, technology transfer, and full regulatory support. Additionally, the facility is equipped to perform GMP-compliant complex gene editing steps and generate cell banks, including clonal banks. Evotec’s end-to-end development capabilities are complemented by support for GLP studies, Tox-batch manufacturing, and integration with the certified clinical CRO at their Verona site.
