Erleben Sie SKAN’s Zell- & Gen-Therapie Isolatoren auf diesem Kongress!

Hören Sie unserer Fachexpertin Dr. Silvia Aldi zu bei ihrem Vortrag:

6. Dezember, 15:00 Uhr:

Novel concept for isolators to manufacture ATMPs and Biologics

In the manufacturing of Advanced Therapy Medicinal Products (ATMP) the need for technology transfer from traditional lab bench work to 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 process, from the sample collection to the cell handling and gene editing, up to the final fill and finish formulation.

Isolator technology becomes a natural next step to increase cell and gene therapy production and quality control. Recently developed isolators allow for upstream, downstream, and aseptic filling steps to be performed in a closed system with a validated aseptic environment control avoiding cross-contamination.

In our first case study, we show the production of CAR T-cell medicinal products by using an integrated multi-chamber and flexible isolator system, developed to follow and support each step from the T-cell activation up to the gene editing and final cell suspension preparation.

The second case study focuses on the production of mesenchymal stromal/stem cell-based products in a compact modular isolator system with fast material transfer options.

Furthermore, a third case study based on tissue engineering products in the commercialization phase will be shown. Bioburden reduction and material transfer from grades C and D into a grade A, i.e. for living cells, is an extremely relevant argument.

Our validated H2O2 decontamination cycles allow rapid transfers of cells and other sensitive materials in a safe manner to protect the product’s quality and sterility.


Lösungen im Bereich Arzneimittel für neuartige Therapien (ATMP)

Weitere Veranstaltungen

  • Interpack 2023

    Live, Stand 15A24
    Düsseldorf, Deutschland

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    Messe Düsseldorf, Messeplatz

    40474 Düsseldorf