Meet FDA Regulations with iPSC Best Practice Manufacturing Protocols with a View Towards Commercialization

Time: 9:00 am - 12:00 pm
day: Workshop A


Regulations 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