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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
                                                          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, 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.  

                                                          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 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

                                                          Christina Dietzer

                                                          Quality Management

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

                                                          ☎ 089-4400-52883


                                                          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

                                                          Luisa Albert

                                                          Administration

                                                          ✉ Luisa.Albert@med.uni-muenchen.de

                                                          ☎ 089-4400-54816

                                                          Patents and Publications

                                                          - 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.

                                                          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

                                                          Impressum

                                                          Datenschutz

                                                          Kontakt

                                                          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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                                                          • Mission
                                                          • 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
                                                            • Ped-COVID-19 Study
                                                            • Michael Albert
                                                            • Scivias Study
                                                          • PhD Program
                                                          • Technology platforms
                                                            • Bioinformatics
                                                            • Flow Cytometry
                                                            • High throughput sequencing
                                                            • Microscopy
                                                            • Pre-GMP Facility
                                                            • Mass spectrometry
                                                            • Hauner Biobank
                                                          • Events
                                                            • Meinhard von Pfaundler-Lectures
                                                            • Klaus Betke Symposium
                                                          • Join us!
                                                          • Contact