V5 Ultimate
Manufacturing

Apheresis

leukapheresis

TL;DR

A donor/patient procedure that separates and collects specific blood components (often leukocytes for cell therapy) and returns the rest, anchoring chain-of-identity for autologous therapies.

Apheresis is the collection technique used to obtain the starting material for most cell and gene therapies (leukapheresis for CAR-T, plateletpheresis for transfusion). The collection event anchors the autologous Chain of Identity (CoI): patient identifiers, collection device, and timestamps that must travel with the product through manufacturing and back to the same patient.

V5 begins the CoI at the apheresis event and enforces identity matches at each subsequent step.

Regulatory anchors
  • 21 CFR 1271
  • 21 CFR 606
  • AABB Standards
Industries that live with this
Blood & TissuePharmaceutical
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.
Related terms
Chain of IdentityDonor eligibilityCell & gene therapy manufacturingVein-to-Vein TimeISBT 128
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