LARGE-SCALE ISOLATION OF CD34-LEVELS OF PURITY AND RECOVERY( CELLS USING THE AMGEN CELL SELECTION DEVICE RESULTS IN HIGH)

The Amgen Cell Selection Device (ACSD) is a fully automated system bas ed on the research scale magnetic-activated cell separation (MACS) sys tem (Miltenyi Biotech GmbH, Bergisch Gladbach, Germany) for the select ion of CD34+ cells. Leukapheresis products (LP) (n = 30) from normal d onors mobilized with recombinant human granulocyte colony-stimulating factor (rhG-CSF) were selected with the ACSD to evaluate the performan ce of this system. The starting LP contained a median of 0.51% CD34+ c ells (range 0.21%-1.54%) and a median WBC count of 3.0 x 10(10) (range 1-4.7 x 10(10) cells). After selection on the ACSD a mean purity of 9 1.5% +/- 0.6% CD34+ cells was obtained, with a median purity of 95.5% CD34+ cells. A median of 98 x 10(6) total CD34+ cells were recovered p ostselection, with a range of 31-323 x 10(6) cells collected from the LP. This represented a mean recovery of 81.7% +/- 6% of CD34+ cells an d a median of 78% compared with starting CD34+ cell numbers in the LP. PACS analysis of the selected products demonstrated a 4-5 log depleti on of T cell subsets, including CD3, CD4, CD8, and CD56 subsets. These data demonstrate the high performance obtained with the ACSD resultin g in a final product of greater than 90% purity of CD34+ cells. CD34cells selected with the ACSD represent an ideal product for clinical a pplications, such as tumor cell purging, T cell depletion for allogene ic transplant, ex vivo expansion, and gene therapy.