As ATMP programs complexity increase, genomic-stability risk becomes a central quality and regulatory challenge. This whitepaper summarizes Clean Cells’ ten years of GMP cytogenetics experience (2015–2025) with more than 500 samples analyzed, ~40,000 metaphase karyotypes and ~90,000 FISH nuclei read, with 309 clonal aberrations detected across CAR-T, NK, T-Reg and pluripotent stem-cell programs.
A step-by-step cytogenetics strategy:
- broad non-GMP karyotype profiling during development,
- early tailored FISH probe design,
- and validated GMP assays for release
reduces unexpected OOS events, shortens time-to-resolution when aberrations occur, and strengthens regulatory submissions.
Inside you will find methods and validation notes, two representative case studies (a CAR-T balanced translocation and a trisomy selection in pluripotent cells), a decision framework for when to apply karyotyping/FISH/dPCR, and actionable recommendations for integrating cytogenetics into your ATMP development plan.
