Bridging the Healthy & Patient Starting Material Gap for Robust Process Development & Ensuring Manufacturing Robustness

Starting material limitations and quality issues pose significant risks to cell therapy

process development, yet is often identified too late. Donor-to-donor variability,

cryopreservation losses, and inadequate material for analytical validation create

bottlenecks across functions. Join this workshop to discuss strategies for classifying

donors, optimizing cell recovery post-thaw, addressing media composition challenges,

and ensuring cross-functional teams have sufficient high-quality material for both

process development and analytical testing.

This workshop will gather experts to discuss:

  • Optimizing cryopreservation and thawing protocols to minimize cell loss and maintain viability for consistent downstream processing
  • Classifying donors and implementing manufacturing adaptations based on variability to control process parameters and ensure product quality
  • Addressing cell culture media composition uncertainties and logistical challenges to improve starting material consistency across disease indications
  • Coordinating between process development and analytical teams to secure sufficient quality material for validation, qualification, and robust testing