Ensuring source material consistency and continuity for commercialization of advanced therapiesPublished: March 30, 2020
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
Dominic Clarke, Global Head of Cell Therapy, HemaCare
Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He is the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies. Previous roles include, Global Product Manager for Charter Medical’s cell therapy and bioprocessing single-use systems portfolio and Director of Research and Development for BioLife Solutions.Dominic currently serves as the co-chair for the International Society for Cell and Gene Therapies Process and Product Development Committee with efforts directed towards translating research and process development from bench to clinic.
Amy Shaw, Lead, Cell Therapies Engineering and Automation Development at Takeda (Formerly: Senior Scientist, Cell Therapy Development, Beam Therapeutics)
Amy Shaw joined Takeda in March 2020, as Lead, Cell Therapies Engineering and Automation Development, having previously worked within the Cell Process Development team at Beam Therapeutics. At Beam, she lead the CART development efforts for Beam’s novel allogeneic platform. Prior to Beam Therapeutics, Amy worked developing an autologous tumor associated antigen T cell product into manufacturing and through Phase I at Torque Therapeutics. She began her work in process development introducing process changes to improve manufacturing of Kymriah at Novartis.
Christopher Good, Director, Cell & Gene Therapy Logistics, Biocair
Christopher Good holds a BSc in Chemistry and Chemical Technology and joined Biocair, a specialist logistics provider dedicated to the pharmaceutical, biotechnology and life sciences sector, in 2002. During this time, he has worked with many large multinational clients, developing and delivering innovative solutions to their specialist logistical needs. These include the design and implementation of bespoke packaging, as well as building and managing complex global supply chains. Based in Cambridge, UK, Christopher continues to work closely with clients and colleagues alike to develop and provide best in class solutions and services in complex areas such as the provision of Cell & Gene Therapy logistics.
Minerva Sanchez, Cell Process Development Engineer, Beam Therapeutics
Joining our panel following the presentations, is Minerva Sanchez. Minerva is a bioengineer working at Beam Therapeutics, working in the development and characterization of novel cell processes for both autologous cell and gene therapy products.