# Apheresis and starting-material collection

Source: https://onco.cc/technologies/apheresis-starting-material/  
OnCo record `apheresis-starting-material` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Apheresis is collecting a patient's white blood cells through a machine over several hours. Every autologous CAR-T begins here, and the quality of these cells shapes the final product.

## Summary

Leukapheresis on Terumo BCT Spectra Optia or Fresenius Kabi Amicus/LOVO devices collects mononuclear cells at qualified centres; T-cell fitness at collection (affected by prior chemotherapy, bendamustine, and disease burden) predicts CAR-T expansion and response. Slot availability at apheresis units is a hidden bottleneck for CAR-T access, and standardisation of collection protocols is part of every sponsor's site qualification.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-09-08
- Tags: supporting
- Principle: Continuous-flow centrifugation separates mononuclear cells from returning blood; product is characterised (CD3 count, viability) and shipped fresh or cryopreserved to manufacturing.
- Strengths: Mature hospital procedure; Same devices serve stem-cell transplant
- Limitations: Capacity at treatment centres; Variable T-cell fitness after prior therapy; Timing conflicts with bridging therapy

## Sources

- FDA guidance: considerations for the development of CAR T cell products: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-development-chimeric-antigen-receptor-car-t-cell-products

## Connected records

- fronts: [Cell Therapy](https://onco.cc/fronts/cell-therapy/)
- technologies: [Autologous CAR-T manufacturing, batch by batch](https://onco.cc/technologies/car-t-manufacturing-process/), [Autologous stem cell transplant (high-dose therapy)](https://onco.cc/technologies/autologous-stem-cell-transplant/), [CAR-T cell therapy](https://onco.cc/technologies/car-t/), [Cryopreservation and cell-therapy cold chain](https://onco.cc/technologies/cell-therapy-cold-chain/), [Dendritic cell vaccines](https://onco.cc/technologies/dendritic-cell-vaccines/), [TCR-T cell therapy](https://onco.cc/technologies/tcr-t/)
- companies: [Fresenius Kabi](https://onco.cc/companies/fresenius-kabi/), [Terumo Blood and Cell Technologies](https://onco.cc/companies/terumo-bct/)
- terms: [Apheresis (leukapheresis)](https://onco.cc/terms/apheresis/), [The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting](https://onco.cc/terms/lymphoma-tx-car-t-pathway/)
- key papers: [ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL](https://onco.cc/key-papers/paper-eliana-tisagenlecleucel-nejm-2018/)
- drugs: [Plerixafor](https://onco.cc/drugs/plerixafor/)

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