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HomeGlossaryVein-to-Vein Time
Manufacturing

Vein-to-Vein Time

v2v time

In short

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
Where this term comes up
Blood & TissuePharmaceutical
How V5 handles it
eBMR / eDHR — the batch record fills in as the work is done.
When operators record their work at the step, the batch record no longer has to be assembled afterwards. People review it and decide release.
Example reports
V5Ultimate

Sample report

Electronic Batch Manufacturing Record (eBMR)

Plan & make

Electronic Batch Manufacturing Record (eBMR)View on screen or print
V5Ultimate

Sample report

Electronic Device History Record (eDHR)

Plan & make

Electronic Device History Record (eDHR)View on screen or print
→ All example reports
Related terms
ApheresisChain of IdentityChain of Custody
Software that covers Vein-to-Vein Time
V5 Ultimate CGT Manufacturing Software
Autologous COI from apheresis to infusion, allogeneic lot genealogy from donor to bag, viral-vector eBR, ISBT 128 / SEC-178…
V5 Ultimate Tissue Bank Software
V5 provides lot status, recorded movements, configured processing steps and linked lab samples. Confirm how your HCT/P…
V5 Ultimate (FDA Compliance)
V5 Ultimate is a single-platform FDA compliance system for US manufacturers regulated under 21 CFR — pharma (210/211), medical…
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