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
Chris has 8+ years working in various roles within Ecolab, and in his current role, Chris is the bio-decontamination specialist in Ecolab’s team of Global Technical Consultants where he is a technical subject matter expert on hydrogen peroxide vapor technology, products and services and their uses in the Life Sciences and Healthcare markets. Chris also hosts webinars and presents at industry events to provide technical thought leadership to audiences of the various life sciences sectors where automated decontamination technology is prevalent.
Senior Microbiology Technical Consultant,Ecolab
Don is a member of the European Pharmacopeia Group 1 Microbiology Committee and the USP Microbiology Expert Committee. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and is a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans 40 years of research, quality control and quality assurance in the pharmaceutical, cosmetic, and food industries. Currently Don is also an adjunct instructor in the biopharmaceutical quality graduate program at University of Maryland Baltimore County. Don is an invited speaker on many topics and presents at global and national events on a variety of subjects within the pharmaceutical industry. As an active member of many industry associations, Don is able to advise on numerous challenges that the pharmaceutical industry faces.