Designing GMP-Ready Clonal iPSC Banks: Practical CMC Controls in a Translational Facility
Time: 3:40 pm
day: Day One Track B Afternoon
Details:
- Sharing a concise, end-to-end framework implemented in a translational iPSC biomanufacturing environment to move from research workflows into GMP-compatible production
- Outlining practical CMC controls including single-cell derivation, raw material qualification, in-process genomic monitoring, and documentation to preserve identity and provenance
- Attendees will leave with a checklist to design robust release criteria for iPSC banks and a view of how process analytics and digital records support efficient tech transfer across sites
