Cell Therapy Manufacturing Topic: Standardizing TBNK Flow Cytometry QC in Cell Therapy Manufacturing: Moving Beyond PBMC Controls
08 Sept 2026
Gene Therapy Development
- How are teams currently controlling TBNK immunophenotyping variability in GMP cell therapy manufacturing, and where are PBMC-based controls introducing noise into in-process testing and release workflows?
- What evidence is required to incorporate polymer-based TBNK controls into a validated control strategy, including equivalency to PBMCs, stability, and cross-site or cross-instrument performance?
- How could standardized synthetic controls support more automated and digital QA approaches in flow cytometry, including simpler trending, reduced bridging studies, and better multisite harmonization?
- Where in the CMC lifecycle—method development, tech transfer, process performance qualification, or routine release—would a shelf-stable, non-biohazardous TBNK control have the greatest operational impact?
- For clinical diagnostic validation, where can polymer-based cell mimics realistically replace PBMCs in analytical validation and QC, and where are primary clinical specimens still required for intended-use claims and commutability?
Facilitator TBC