Manufacturing
Vein-to-Vein Time
v2v time
TL;DR
Elapsed time from apheresis collection to infusion of the engineered cell therapy back into the patient — a critical performance metric for autologous therapies.
Vein-to-Vein (V2V) time spans patient apheresis → cryo/ship → manufacturing → QC release → ship → infusion. It is both a patient-outcome lever and a logistics KPI. Each leg generates GMP records, chain-of-identity checks, and chain-of-custody scans.
V5 tracks V2V as a live KPI across the patient cohort with each step's actuals vs target visible to the manufacturing and clinical team.
Regulatory anchors
- 21 CFR 1271
- FDA CGT Guidance
Industries that live with this
Related terms
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