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Applied advanced analysis to understand manufacturing variance for cell therapy firm

Service Areas
Therapeutic Areas

Gene Therapy & Orphan Disease

Client Type

Pre-clinical client

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

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