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