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Scalable Manufacturing for Cell Therapies in Diabetes

Expert Speakers

Manufacturing of cells is complex, labour intensive and costly. As we aim to scale up our efforts to meet commercial demand these factors become prohibitive for successful delivery and uptake of life-changing therapies.

As the cell therapy revolution continues the advances that are being made are staggering however, several core challenges still remain in bringing to market cost effective and scalable manufacturing of cells. Experts in manufacturing and process development will tackle:

  • Automation of manufacturing
  • Analytical development and testing to ensure product quality
  • Reproducibility and comparability
  • Cryopreservation and storage

Join leaders in development as they share key learnings in case studies, have an open and frank panel discussion and become an active participant in the conversation during breakout discussion groups.

Key Topics of Discussion

*All agenda times in EST

9:00 am Introduction & Opening Remarks

9:20 am CASE STUDY: The Development of Allogeneic Mesenchymal Stem Cell Therapies for Type 1 Diabetes

Synopsis

• Preserve endogenous insulin production in adult patients diagnosed with type I diabetes by immunomodulatory allogeneic mesenchymal stromal cells
• Redundant source of primary hMSC for scalable manufacturing
• Selection algorithm developed to select optimal cells based on multiple functional assays and mechanisms of action
• Drug product currently in two clinical trial

9:40 am CASE STUDY: Improving Scalability to Take Cell Replacement Therapies to a Commercial Scale

Synopsis

• Understanding the extra level of complexity that comes with differentiating pluripotent stem cells to target cell types at scale through changes in media types and complex media exchanges
• Highlighting the benefits of using suspension culture and 3D aggregates in bioreactors to produce more cells per facility space
• Outlining a need to vision your full-scale process: introducing good practice from the start to avoid bridging structures and ease path to commercialization
• Hybrid differentiation systems: moving from 2D to 3D mid differentiation, is this feasible on a large scale?

10:00 am Addressing the Need for Effective Cryopreservation to Maintain the Function of Transported and Stored Cells

Synopsis

• Developing robust cryopreservation protocols for the supply and transport of cell therapies
• Is standardization of the optimal cold supply chain design possible?
• Addressing the value of automation in cryopreservation
• Formulating cells for infusion after thawing, what is the best protocol?
• Discussing whether shipping cryopreserved products is the best option over local final preparation and formulation of the product

10:20 am Speed Networking

11:00 am PANEL DISCUSSION: Moving Towards Commercialization – Forward Thinking Strategies

  • Mathias Svahn Chief Executive Officer, NextCell Pharma
  • Krister Bokvist Senior Expert Consultant, Diabetes R&D, YourEncore
  • Lorenzo Piemonti Director, Diabetes Research Institute & Associate professor, Università Vita-Salute San Raffaele

Synopsis

• Determining suitable risk analyses for supply chain, logistics and durability of suppliers
• Debating diversifying source providers to avoid supply deficits
• How do you ensure providers can meet the scale you need?
• Highlighting the importance of communicating with the FDA and regulatory bodies to ensure a smooth route to commercialization
• Assessing the cost of current diabetes treatment: is a cure for diabetes with a moderate increase in cost feasible?
• Outlining important aspects of manufacturing cell therapies for diabetes
• Outlining the GMP facilities required to manufacture beta cells on a large scale as well as emphasizing the need for consistency of the product
• Addressing the large scale manufacturing restrictions of devices: will the bespoke nature of each company’s device hinder commercialization?
• Assessing the potential impact of the large quantity of reagents needed on large scale manufacture

12:00 pm BREAKOUT DISCUSSION GROUPS

  • Mathias Svahn Chief Executive Officer, NextCell Pharma
  • Krister Bokvist Senior Expert Consultant, Diabetes R&D, YourEncore
  • Lorenzo Piemonti Director, Diabetes Research Institute & Associate professor, Università Vita-Salute San Raffaele

Synopsis

• What are the limitations of large scale manufacturing of devices and will the bespoke nature of each
company’s device hinder commercialization?
• What is the feasibility of hybrid differentiation systems and moving from 2D to 3D mid differentiation on a
large scale?
• What are the GMP facility requirements to manufacture beta cells at commercial scale?
• How can you ensure product quality and consistency and what are the product characterization tools and
technologies that should be utilized?
• What is the optimal protocol for formulating cells for infusion after thawing?

12:45 pm Feedback Summary & Key Takeaways

1:00 pm End of Working Group B