Pre-GMP Facility
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:
- Specificity
- Purity
- Potency
- Identity
Standardly, stability assays are perfomed in order to determine the shelf-life of the cell products.

Dr. Theresa Käuferle
Head of Pre-GMP Facility
Executive Management
✉ Theresa.Kaeuferle@med.uni-muenchen.de
☎ 089-4400-52338

Dr. Ramona Krauß
Regulatory Affairs, Ethics and Biobanking
✉ Ramona.Krauss@med.uni-muenche.de
☎ 089-4400-52759


Prof. Tobias Feuchtinger
Dr. von Hauner Children´s Hospital
Head of Haematology/Oncology Department
✉ Kinderkrebszentrum@med.uni-muenchen.de
☎ 089-4400-52759

Lena Jablonowski
Doctoral Researcher (PhD tack)
✉ Lenamaria.Jablonowski@med.uni-muenchen.de
☎ 089-4400-57791

- 2 Patent Applications
- Kaeuferle T et al. CRISPR-Cas9-Mediated Glucocortioid Resistance in Virus-Specific T cells for Adoptive T Cell Therapy Posttransplantation. Mol Ther. 2020 Jun 11:S1525-0016(20)30292-6. doi: 10.1016/j.ymthe.2020.06.002.
Contact:
Dr. Theresa Käuferle
Head of Pre-GMP Facility
Dr. von Hauner Children´s Hospital
Dep. of Haematology/Oncology
Tel.: 089/4400-52338