Large-Scale Isolation of CD34+ Cells Using the Amgen Cell Selection Device Results in High Levels of Purity and Recovery

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Abstract
The Amgen Cell Selection Device (ACSD) is a fully automated system based on the research scale magnetic-activated cell separation (MACS) system (Miltenyi Biotech GmbH, Bergisch Gladbach, Germany) for the selection of CD34+ cells. Leukapheresis products (LP) (n = 30) from normal donors mobilized with recombinant human granulocyte colony-stimulating factor (rhG-CSF) were selected with the ACSD to evaluate the performance of this system. The starting LP contained a median of 0.51% CD34+ cells (range 0.21%–1.54%) and a median WBC count of 3.0 × 1010 (range 1–4.7 × 1010 cells). After selection on the ACSD a mean purity of 91.5% ± 0.6% CD34+ cells was obtained, with a median purity of 95.5% CD34+ cells. A median of 98 × 106 total CD34+ cells were recovered postselection, with a range of 31–323 × 106 cells collected from the LP. This represented a mean recovery of 81.7% ± 6% of CD34+ cells and a median of 78% compared with starting CD34+ cell numbers in the LP. FACS analysis of the selected products demonstrated a 4–5 log depletion of T cell subsets, including CD3, CD4, CD8, and CD56 subsets. These data demonstrate the high performance obtained with the ACSD resulting in a final product of greater than 90% purity of CD34+ cells. CD34+ cells selected with the ACSD represent an ideal product for clinical applications, such as tumor cell purging, T cell depletion for allogeneic transplant, ex vivo expansion, and gene therapy.

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