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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
                                                                                  • English - en

                                                                                  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
                                                                                    • Gaertner 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!