Clinical-scale production of granulocyte progenitor and post-progenitor cells using daniplestim, leridistim, Progenipoietin, Promegapoietin and autologous plasma

Background Supplementation of PBPC autografts with ex vivo expanded PBMC may significantly reduce or eliminate the period of neutropenia associated with high-dose chemotherapy. Methods: Unmanipulated growth-factor mobilized PBMC were expanded in media containing daniplestim, leridistim, Promegapoietin, and Progenipoietin (DLPP) and 2% autologous plasma at 4 2 105 PBMC/mL, first in 25 cm2 T-flasks, with sampling on Days 7, 10, 13 and 15, and then in 1264 cm2 Nunclon Cell Factories, with sampling on Days 7 and 13. Results: In T25-flasks, maximal CFU-GM expansion ([38.2 - 9.5]-fold) occurred on Day 10, whereas maximal total cell expansion ([6.7 - 1.1]-fold) occurred on Day 15. Production of CD15+CD11b- and CD15+CD11b+ granulocytic post-progenitors (3.0 - 0.4 2 106 and 3.7 - 0.9 2 106, respectively) was also maximal at Day 15. Compared with the previously studied combination of Flt3L, PIXY321, G-CSF, GM-CSF and Epo, the DLPP cocktail performed similarly, with the exception of yielding lar...