RSSL Sterility Webinar Series: Sterility Assurance in Cell Therapy Products
: 24 Nov 2021
Hosted by Tim Sandle, RSSL's complimentary sterility webinar series continues throughout 2021, with more sessions to guide you through the complex world of Sterility Testing.
Focusing on the latest draft of the EU GMP Annex 1 for sterile products manufacture, the series will discuss the different aspects that all manufacturers need to consider to remain compliant, including quality risk management, contamination strategy, cleanroom certification, and water systems.
Cellular therapy products represent a new wave in pharmaceuticals and include cellular immunotherapies, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications. While the products are novel, sterility assurance concerns remain fundamental.
- Sterility assurance principles
- Sterility testing
- Rapid microbiological methods
- Environmental monitoring
- Facility, equipment, raw materials, test system, and personnel
- Control of the collection, processing, packaging, and distribution of cell products
Contact us for more information