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                                                                                1. CCRC-HaunerEN
                                                                                2. Technology platforms
                                                                                3. Pre-GMP Facility

                                                                                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
                                                                                • Pre-clinical data finalization for Clinical Trial Submission
                                                                                Cell Product Manufacturing

                                                                                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 and magnetic seperation of cells in a functionally closed system.

                                                                                The platform´s flexibility allows production of a wide range of cell products under S2 conditions. Further, automation within this device allows harmonization of cell-production processes in case of multicentric production strategies in clinical studies.

                                                                                With the electroporator "GTx" (MaxCyte) we also have a GMP-compatible platform for the production of CRISPR/Cas-engineered cell therapy products, which can be combined with our existing platform via a tube system. The new range of non-viral "genetic engineering" processes enables the development of a wide variety of innovative T-cell therapy approaches.

                                                                                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.

                                                                                Quality Control

                                                                                "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.

                                                                                Product Characterization

                                                                                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. 

                                                                                Staff

                                                                                Dr. Theresa Kaeuferle

                                                                                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

                                                                                Christina Dietzer

                                                                                Quality Management

                                                                                ✉ Christina.Dietzer@med.uni-muenchen.de

                                                                                ☎ 089-4400-52883


                                                                                Teresa Augustin

                                                                                Administration

                                                                                ✉ Teresa.Augustin@med.uni-muenchen.de

                                                                                ☎ 089-4400-54817

                                                                                Nadine Stoll

                                                                                Technician

                                                                                ✉ Nadine.Stoll@med.uni-muenchen.de

                                                                                ☎ 089-4400-57790

                                                                                Prof. Tobias Feuchtinger

                                                                                Dr. von Hauner Children´s Hospital

                                                                                Head of Haematology/Oncology Department

                                                                                ✉ Kinderkrebszentrum@med.uni-muenchen.de

                                                                                ☎ 089-4400-52759

                                                                                Mira Reger

                                                                                Clinical Trial Management

                                                                                ✉ Mira.Reger@med.uni-muenchen.de

                                                                                ☎ 089-4400-54816

                                                                                Lena Jablonowski

                                                                                Doctoral Researcher (PhD track) 

                                                                                ✉ Lenamaria.Jablonowski@med.uni-muenchen.de

                                                                                ☎ 089-4400-57791

                                                                                Maximilian Zwermann

                                                                                Doctoral Researcher (MD track) 

                                                                                ✉ Maximilian.Zwermann@med.uni-muenchen.de

                                                                                ☎ 089-4400-57790

                                                                                Patents and Publications

                                                                                - 2 Patent Applications

                                                                                - Kaeuferle T et al. Genome-wide off-target analyses of CRISPR/Cas9-mediated T-cell receptor engineering in primary human T cells. Clin. Transl. Immunol. 2022 Jan 11:e1372. doi: 10.1002/cti2.1372

                                                                                - Stief TA, Kaeuferle T, Müller TR et al. Protective T-cell receptor identification for orthotopic reprogramming of immunity in refractory virus infections. Mol Ther. 2021 May 28:S1525-0016(21)00303-8. doi: 10.1016/j.ymthe.2021.05.021

                                                                                - 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.

                                                                                - Kaeuferle T et al. Strategies of adoptive T-cell transfer to treat refractory viral infections post allogeneic stem cell transplantation. J Hematol Oncol. 2019 Feb 6:12(1):13. doi: 10.1186/s13045-019-0701-1

                                                                                Links
                                                                                • Research Lab AG Feuchtinger
                                                                                • TRACE - a multinational Phase III T-cell Therapy Study
                                                                                • Follow TRACE on LinkedIn

                                                                                Contact:

                                                                                Dr. Theresa Käuferle

                                                                                Head of Pre-GMP Facility

                                                                                Dr. von Hauner Children´s Hospital

                                                                                Dep. of Haematology/Oncology

                                                                                Tel.: 089/4400-52338

                                                                                E-Mail: Theresa.Kaeuferle@med.uni-muenchen.de

                                                                                Research at CCRC Hauner

                                                                                Contact LMU Klinikum

                                                                                Contact CCRC Hauner

                                                                                Haunersches

                                                                                CCRC Hauner

                                                                                Kinderklinik und Kinderpoliklinik

                                                                                im Dr. von Haunerschen Kinderspital

                                                                                Ludwig Maximilians Universität München

                                                                                Lindwurmstr. 4

                                                                                80337 Munich, Germany

                                                                                ☎ +49-89-4400-57705

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                                                                                Imprint | Data-Safety
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                                                                                • Deutsch - de
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                                                                                Comprehensiv...

                                                                                • Clinical research
                                                                                  • Interdisciplinary pediatric study center (Hauner iPSC)
                                                                                  • Ped-COVID-19 Study
                                                                                  • Michael Albert
                                                                                  • Scivias Study
                                                                                  • TRACE Study
                                                                                  • ImmGenDC Study
                                                                                  • Hematology/Oncology/Coagulation
                                                                                • Research Labs
                                                                                  • Binder Lab
                                                                                  • Bohlen Lab
                                                                                  • Braun Lab
                                                                                  • Griese Lab
                                                                                  • Hauck Lab
                                                                                  • Hübner Lab
                                                                                  • Jeremias lab
                                                                                  • Kim-Hellmuth Lab
                                                                                  • Klein Lab
                                                                                  • Koletzko Lab
                                                                                  • Kotlarz Lab
                                                                                  • Lange-Sperandio Lab
                                                                                  • von Mutius Lab
                                                                                  • Nußbaum Lab
                                                                                  • Rosenecker Lab
                                                                                  • Schaub Lab
                                                                                  • Schmid Lab
                                                                                  • Schwerd Lab
                                                                                • PhD Program
                                                                                • Technology platforms
                                                                                  • Bioinformatics
                                                                                  • Flow Cytometry
                                                                                  • High throughput sequencing
                                                                                  • Microscopy
                                                                                  • Pre-GMP Facility
                                                                                  • Mass spectrometry
                                                                                  • Hauner Biobank
                                                                                  • Organoid Lab
                                                                                  • Humangenetik am Hauner
                                                                                • News/Events
                                                                                  • News
                                                                                  • Rare Disease Day
                                                                                  • ECHO-Meeting
                                                                                  • Meinhard von Pfaundler-Lectures
                                                                                  • Klaus Betke Symposium
                                                                                • Join us!