Apheresis
leukapheresis
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.
- 21 CFR 1271
- 21 CFR 606
- AABB Standards
UltimateSample report
Electronic Batch Manufacturing Record (eBMR)
Plan & make
UltimateSample report
Electronic Device History Record (eDHR)
Plan & make
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