ASEPTIC TECHNOLOGIES GLOBAL SHOWCASE PRESENTATION Novel concept for isolators to manufacture ATMPs and Biologics
Wednesday, May 31, 2023 07:00 PM - 07:30 PM
Global Showcase Theater
Global Showcase Presentation
Novel concept for isolators to manufacture ATMPs and Biologics
Presenter
Laurent Fluhr, Sales Manager, Skan AG, Switzerland
In the manufacturing of advanced therapy medicinal products (ATMP) the need of technologies transfer from traditional lab bench work to therapies’ production and commercialization phases became a bigger challenge. Due to the process requirements of ATMP manipulation, a high sterility assurance is required all the way through the workflow process; from the sample collection to the cell handling and gene editing up to final fill and finish formulation. Isolator technology become a natural next step to increase cell and gene therapies production and their quality control. Recently developed isolators allow for upstream, downstream and aseptic filling steps to be performed in a closed system with a validated aseptic control environment avoiding cross-contamination. In our case studies, we show the production of allogeneic and autologous CAR T-cell medicinal products, mesenchymal stromal cells-based therapies and tissue engineering products by using different modalities of closed systems isolators based either on an integrated multi-chamber and flexible isolator system or on small and compact isolators developed to follow and support each step of the GMP manufacturing.
Presenter
Laurent Fluhr, Sales Manager, Skan AG, Switzerland
In the manufacturing of advanced therapy medicinal products (ATMP) the need of technologies transfer from traditional lab bench work to therapies’ production and commercialization phases became a bigger challenge. Due to the process requirements of ATMP manipulation, a high sterility assurance is required all the way through the workflow process; from the sample collection to the cell handling and gene editing up to final fill and finish formulation. Isolator technology become a natural next step to increase cell and gene therapies production and their quality control. Recently developed isolators allow for upstream, downstream and aseptic filling steps to be performed in a closed system with a validated aseptic control environment avoiding cross-contamination. In our case studies, we show the production of allogeneic and autologous CAR T-cell medicinal products, mesenchymal stromal cells-based therapies and tissue engineering products by using different modalities of closed systems isolators based either on an integrated multi-chamber and flexible isolator system or on small and compact isolators developed to follow and support each step of the GMP manufacturing.
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