2019
January
30. - 31.01.2019
Gene Therapy -
Ready for the Market? DECHEMA-Haus in Frankfurt/Main, Germany
March
19.03.2019
ZelltherQC Project Meeting at the
Fraunhofer-EMB in
Lübeck,Germany
As part of the ZellTherQC project, a knowledge sharing meeting was organised on March 19, 2019 at the Fraunhofer Institute for Marine Biotechnology (EMB) in Lübeck. The aim of the event was to get further insight into regulatory and application-specific aspects of the quality control (QC) of ATMP and to discuss their implementation for the overall project and its subprojects. Moreover, an interactive GAP analysis was developed by the project partners to identify existing gaps in the project in the areas of knowledge (regulations, processes), innovation (technologies, interfaces), resources (partners, capabilities) and business (market access, user needs). Regulatory advice regarding relevant guidelines and processes for the QC of ATMP was given by the Paul Ehrlich Institute and valicare GmbH. On the user/developer side, BioNTech GmbH as a manufacturer of immune therapies and the Institute for Bioprocess and Biosystems Technology of the Technical University (TU) Hamburg were able to provide the project partners with important impulses in the field of therapeutic T-cell and stem cell products for further R&D work in the project. In order to understand the practical requirements on the QC of ATMP in more detail, contacts to other users of ATMP, such as tumour centres, hospitals, transplant centres and QC laboratories, are to be established for further knowledge sharing.
Figure 1: Participants of the meeting
Figure 2: Interactive GAP analysis
June
2018
December
November
29.11.2018
User workshop at the Lower Saxony Centre for Biomedical Engineering, Implant Research and Development (NIFE) in Hanover, Germany
13.11.2018
Quality aspects in the production of ATMP, organized by PEI in Potsdam, Germany
September
06. - 07.09.2018
Symposium "Industrial Cell Technology", at the Fraunhofer-EMB in Lübeck,
Germany
June
20.06.2018
Kick-off event - ZellTherQC
On June 20, 2018 the kick-off meeting of the project took place at EurA AG in Hamburg, where the importance of the involvement of users and experts from the field of cell therapy was discussed. The technologies developed in the project are to be used and applied on the market. In order to better take into account the requirements, market needs and regulatory aspects in the quality control of cell therapies and tissue engineered products in their development work, the partners want to work closely with future users such as pharmaceutical/biotech companies, manufacturers of medical devices and users of cell therapeutics (clinical institutions and medical practices).