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Applied advanced analysis to understand manufacturing variance for cell therapy firm
Client Problems
A pre-clinical client with a cell therapy product wants to identify the root cause of manufacturing variations
Variance on the process was too high with too many lots not passing, impacting patient outcomes
The release timeline was too long, impacting patients availability to get therapy
What We Did
Developed measurements for the process and determined the variance was in the donors and not the process
Applied WBS methodology to map out the process and internal dependencies
Our Results And Insight
Determined that the variance was in the donors, not the process, and there is a lack of consistency, even from the same donor
Determined complex two factor and three factor interactions
Discovered the donor material characteristics to improve pre-screen and process success rate
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Service Areas Details
Operation Strategy (CMC)
Therapeutic Areas Details
Cell therapy