Step 1 · Analyze
Cell line terminated at Passage 17 during expansion
Termination of cell line 293SGW020526 during the expansion process at Passage 17, halting the planned manufacturing campaign. Caught before downstream steps began.
Sublot
293SGW020526 P17
Detection latency
—
Not recorded
Found by
In-process monitoring
Caught before downstream steps
The question that decides this case
Impact is reported as two verdicts and never collapsed into one.
What the product data says
Product SISPQ impact is No — the event was caught before downstream steps began, with no impact on product quality or patient safety. DEV-02166 narrative
What the campaign says
Campaign impact is significant — the planned manufacturing campaign was halted. That is what carries the Major criticality. SOP-QM-GEN-000005
Why they stay separate
Product impact and campaign impact are reported separately; a clean product record does not lower the campaign tier. MPP-000073