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
Software that covers Apheresis
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 Blood Bank Software
Donor eligibility as a hard gate, IDM-gated quarantine, ISBT 128 component labelling, transfusion service crossmatch and issue,…
V5 Ultimate Tissue Bank Software
Donor eligibility as a hard gate, DRAI on the kiosk, ISBT 128 labelling, lookback as a single query, cGTP processing records, and…
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