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