Overcoming contamination risks in cell and gene therapy with aseptic GMP process design using isolator technology
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Live30 webinars are thirty minute presentations designed to update you on the latest innovations, applications and data in a fast yet interactive format.
The emergence of cell and gene therapy triggers new challenges related to contamination control. Smaller batch, shorter timeframe to deliver the therapy as well as the shift to new regulatory trends require a revised look on traditional contamination control strategy to make it relevant to cell and gene therapy.
This webinar will explore the benefits which aseptic isolators provide in reducing the risk of contaminating a cell and gene therapy process both during R&D and GMP manufacturing operations. In addition, the role that hydrogen peroxide vapour plays in reducing risk when manipulating living cells or genetic material into an aseptic environment will be addressed. The typical workflow for performing a cell and gene therapy manufacturing process in a modular aseptic isolator will also be outlined, as well the various options available for small scale aseptic filling in a modular isolator.
This webinar will also explore some of the challenges involved in performing cell and gene therapy manufacturing, such as how to transfer living materials into an isolator without bringing any contamination in, but also without compromising the living materials themselves, as some disinfection methods can do.
- The benefits of isolators/barrier technology vs safety cabinets for CGT manufacturing
- Understanding a typical CGT workflow in a modular isolator
- How to transfer living and non-living materials in/out of an isolator
- Hydrogen peroxide vapour permeability testing for living materials
- Options for small scale aseptic filling in a modular isolator for CGT
- How isolators are a strong component of a compliant contamination control strategy in CGT
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