Addressing Comparability and Regulatory QC Assays Through Multi-Modal Single-Cell Analysis
Time: 1:30 pm
day: Day 1 - Track B - Afternoon
Details:
- CAR-T therapies (both autologous and allogeneic) are currently experiencing headwinds, and a major issue is sufficient analytical characterization to capture CQAs in a uniform and consistently reliable, rapid manner
- Regulatory and QC endpoints are coming under increased scrutiny, while patients are endlessly waiting for these therapies to be democratized and accessible
- This presentation will address how heterogeneity confounds these complexities, and how some industry entities are addressing multiple CQAs (transduction/VCN, dynamic cell fitness, allogeneic cell gene editing, genetic stability, and comparability) directly by measuring all these attributes at the single-cell level, simultaneously, with a single assay that is GxP-deployable with minimal CVs and consideration for 21CFR Part 11 compliance, while also satisfying ICH Q6B guidance
