Data source: Benchling · liveNeogene Stevenage · GxP
v0.1 prototype
MO
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Lot
NGN-2026-0138
CAR-T (BCMA) · r/r MM · Rockville (US) · patient PT-8825
AI RELEASE RECOMMENDATION
Decision support for NGN-2026-0138
Synthesizes every Benchling-ingested acceptance criterion into a single verdict with reasoning. The reviewer signs off in Benchling.
Acceptance criteria
Live results streamed from Benchling-connected instruments.
| Criterion | Spec | Observed | Instrument | Status |
|---|---|---|---|---|
| Viability Cell count & viability | ≥ 70% | 84.2% | NucleoCounter NC-200 #01analysis → | pass |
| %CD3+ T cells Identity (flow) | ≥ 80% | 92.1% | BD FACSLyric #01analysis → | pass |
| %CAR+ transduction Identity (flow) | 20–60% | 38.6% | BD FACSLyric #01analysis → | pass |
| Vector copy number Safety (qPCR) | ≤ 5 copies/cell | 2.8 | QuantStudio 7 Flex | pass |
| Endotoxin Safety (LAL) | < 0.5 EU/mL | 0.12 EU/mL | EndoSafe nexgen-PTS | pass |
| Sterility (14-day) Safety (microbial) | No growth | No growth (day 8/14) | BacT/ALERT 3D | pending |
| Mycoplasma Safety (qPCR) | Negative | Negative | QuantStudio 7 Flex | pass |
| Potency (cytolysis @ E:T 10:1) Potency | ≥ 40% | 57.3% | xCELLigence RTCAanalysis → | pass |