Pre-Conference Workshop Day
9:00 am Meet FDA Regulations with iPSC Best Practice Manufacturing Protocols with a View Towards Commercialization
- Richard McFarland Chief Regulatory Officer, ARMI
- Jane Lebkowski President, Regenerative Patch Technologies
SynopsisRegulations influence the protocol of each process that makes up the production of iPSCs and their products. With iPSCs being relatively new to therapeutic use, it is important that regulations are considered at each step to ensure robust procedures are implemented in order to produce high quality iPSCs and iPSC products with high efficacies that will fly through the clinic to form successful treatments.
- Questioning how regulations impact iPSC manufacturing to reconsider development strategy and what stages require a higher level of focus, care and attention
- How are quality and potency measured? A guide to aid product development and analytics to ensure safety and IND requirements are met
- Early identification of critical quality attributes
- Important of defining critical process parameters from starting material to final formulation
- Scale-up to meet commercial needs
12:00 pm Lunch Break and Networking
1:00 pm Incorporating Automation and Next Generation Analytics to implement QbD and PAT in iPSC Manufacturing
- Mary Clare McCorry Director, Technology & Process Development , ARMI
- James Dutton Associate Professor, Stem Cell Institute, University of Minnesota
iPSC manufacturing consists of many repetitive procedures leading to turnaround times lasting months and high costs from vast quantities of materials as well as skilled expertise. Novel technologies are coming on the scene to reinvent iPSC manufacturing processes to cut down human error and product variability whilst slashing costs and turnaround time.
- Using automation and advanced technologies to consistently produce iPSC derived product
- A look at the practical considerations: how can these technologies be implemented and how will they reduce costs?
- Will AI remove our need to gain deeper knowledge of the biology of differentiation?
- ARMI’s approach to developing the next generation of iPSC relevant technologies