GMP-grade CD34(+) selection from HLA-homozygous licensed cord blood units and short-term expansion under European ATMP regulations

摘要

Background Based on a synergistic consortium, the cord blood (CB) bank Dusseldorf was responsible for the selection of HLA-homozygous (HLA-h) donors, contacting/re-consenting the mothers, Good Manufacturing Practice (GMP)-grade CD34(+) enrichment, followed by short-term expansion of CD34(+) cells and qualification of the resulting CD34(+) population as advanced therapy medicinal product (ATMP)-starting material. Among 20 639 licensed Dusseldorf cord blood units (CBUs), 139 potential HLA-h donors were identified with the most frequent 10 German haplotypes. 100 % of the donors were contacted, and for 47.5 %, consent was obtained. HLA-A, -B, -C, -DR, -DQ and -DP were determined by sequencing.