V5 Ultimate
Manufacturing

Cell & gene therapy manufacturing

cgt · atmp

TL;DR

GMP manufacture of cell therapies, gene therapies and combination ATMPs — patient-specific or allogeneic batches with complex chain-of-identity and chain-of-custody.

CGT manufacturing operates under 21 CFR 1271 (HCT/Ps), 21 CFR 211/600s (biologics cGMP), FDA's CGT guidance suite (2024–2025 updates) and, in the EU, Regulation (EC) 1394/2007 plus EudraLex Vol 4 Part IV (ATMP GMP). Autologous workflows demand patient-level chain-of-identity (collection → manufacturing → infusion) with two-person verification at every transfer; allogeneic manufacture more closely resembles classical biologics but adds donor-eligibility and viral-safety controls.

Batch records are typically per patient (autologous) or per lot (allogeneic) and must cross-reference apheresis records, vector lot, and the receiving clinical site.

Regulatory anchors
  • 21 CFR Part 1271
  • EudraLex Vol 4 Part IV (ATMP GMP)
  • EC Regulation 1394/2007
Industries that live with this
Pharmaceutical
How V5 handles it
eBMR / eDHR — the batch record writes itself.
When the master is locked and the operator works on the kiosk, the batch record is no longer something to assemble — it’s something to render.
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
21 CFR 211QP releaseICH Q7Conditional release21 CFR Part 1121 CFR 21021 CFR 21221 CFR 58ICH Q9ICH Q10ICH Q2ICH Q6GxPDeviationOOSOOTCAPANCRLine Clearance
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