Bridge to Translation - Immunotherapy from Bench to Bed side
Cellular immunotherapy requires the set-up of GMP-compatible procedures.
The transfer of experimental methods to clinical scale cell engineering includes
- Automation and up-scale of cell product manufacturing
- Set-up and validation of quality control
- Product characterization
For clinical scale cell engineering in a functionally closed system we chose the "CliniMACS Prodigy" device. It offers a platform for GMP-grade cell processing applications enabling fully automated washing, fractionation, cultivation, transduction, electroporation and magnetic seperation of cells in a functionally closed system.
The platform´s flexibility allows production of cell products including a wide array of genetic engineering under S2 conditions. Further, automation within this device allows harmonization of cell-production processes in case of multicentric production strategies.
Set-up of the GMP-conform manufacturing process includes generation of SOP, selection of GMP-compatible reagents and up-scale of lab protocols. Pre-validation runs are performed in order to establish the manufacturing process, train staff and prepare production approval.
"MACSQuant Analyzer" offers a GCP-compatible high-throughput platform for flow-cytometry-based quality control. With a range of automated features, this flow cytometer lays the foundation for standardization of analysis and gating procedures.
- Absolute quantification of cell populations allows dosing of cell products
- Automation allows harmonization and standardization of quality control analyses in case of multicentric production
- Development of MACSQuant "Express Modes" offers fast and easy quality control analyses
Quality control strategies are set-up and validated in accordance to the requirements of regulatory authorities.
According to regulatory requirements cell products are pre-clinically characterized using established validation processes and infrastructures:
Standardly, stability assays are perfomed in order to determine the shelf-life of the cell products.
- Patent Application No. 20 17 6196.2: CRISPR/Cas9-engineered virus-specific T-cell products
- Kaeuferle et al. CRISPR-Cas9 mediated glucocortioid resistance in virus-specific T cells for adoptive T-cell therapy post transplantation, Molecular Therapy (accepted)