Clinical grade purification and expansion of NK cell products for an optimized manufacturing protocol.

ABSTRACT: Allogeneic natural killer (NK) cells are used for adoptive immunotherapy after stem cell transplantation. In order to overcome technical limitations in NK cell purification and activation, the following study investigates the impact of different variables on NK cell recovery, cytotoxicity, and T-cell depletion during good manufacturing practice (GMP)-grade NK cell selection. Forty NK cell products were derived from 54 unstimulated donor leukaphereses using immunomagnetic CD3 T-cell depletion, followed by a CD56 cell enrichment step. For T-cell depletion, either the depletion 2.1 program in single or double procedure (D2.11depl, n?=?18; D2.12depl, n?=?13) or the faster depletion 3.1 (D3.1, n?=?9) was used on the CliniMACS instrument. Seventeen purified NK cell products were activated in vitro by IL-2 for 12?days. The whole process resulted in a median number of 7.59?×?10(8) CD56(+)CD3(-) cells with both purity and viability of 94%, respectively. The T-cell depletion was significantly better using D2.11depl/2depl compared to D3.1 (log 4.6/log 4.9 vs. log 3.7; p?

SUBMITTER: Koehl U 

PROVIDER: S-EPMC3656406 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature