A critical aspect to ensuring patient access to cell and gene therapies (CGT) and continued growth of the industry is having a proper awareness for managing the source material quality and supply chain continuity. The combination of rapid growth, individual product and process complexity, and limited industry-specific guidance or awareness presents ongoing challenges for transitioning from development to clinical and commercial manufacturing scale. For allogeneic therapies, having access to consistent and reliable donors and high quality, GMP-compliant starting material, coupled with the ability to consistently deliver this clinical source material to the required point of use, will be key to long-term success.
Three diverse stakeholders share their experience and insights to help you troubleshoot your own cell therapy raw and starting materials strategy:
- Dominic Clarke of HemaCare introduces the key considerations for starting material sourcing, including addressing translational and scale-up challenges.
- Christopher Good of Biocair highlights regional and regulatory logistics requirements, and the major considerations for shipping clinical/GMP starting materials
- Amy Shaw of Beam Therapeutics provides practical guidance relating to the critical role of both material sourcing and logistics in the effective development of novel advanced therapies, drawing on Beam’s own experiences with the development of its autologous and allogeneic product candidates.
Improve your knowledge of:
- The importance of defining source material requirements for translation of allogeneic advanced therapies
- The benefits of a reliable & recallable donor network for consistent source material access
- The critical requirements for obtaining GMP-compliant source materials necessary for commercial manufacture
- How to navigate the critical aspects in handling, monitoring, and delivering temperature sensitive source materials
- The importance of early planning, coordination, and communication with all stakeholders