. Author manuscript; available in PMC: 2019 Jun 1.

Published in final edited form as: Transfusion. 2018 Mar 12;58(6):1458–1467. doi: 10.1111/trf.14564

Table 1.

Comparative summary of processing results for NK cell manufacturing methods

		CD3_dep (n=37)	CD3_dep/CD56_enrich (n=13)	CD3/CD19_dep (n=94)

Apheresis MNCs	TNC count (x10¹⁰)^*	2.0 ± 0.8	2.4 ± 0.7	2.3 ± 0.7
Apheresis MNCs	% NK cells	11 ± 4	12 ± 6	12 ± 5
Post-column processing	TNC (10⁹)	4.7 ± 2.4	0.6 ± 0.4	4.9 ± 1.4
	% NK cells	38 ± 13	90 ± 7	39 ± 15 (n=25)^†
	% NK cell recovery	79 ± 15	19 ± 11	74 ± 15 (n=25)^†
	Log T-cell depletion	2.7 ± 0.4	4.3 ± 0.5	3.5 ± 0.5 (n=25)^†
Cytokine activated product	% NK cells	39 ± 9	75 ± 6	47 ± 18
Cytokine activated product	Total NK cells infused (x10⁷)^‡	68.7 ± 26.5	25.3 ± 14.0	158.1 ± 109.9

	Processing time (hours)^ˠ	12	17	12
	Processing cost (US dollars)^ˠ	9,757	14,607	12,742

Data is reported as the mean ± SD

Apheresis collection times were 3-hours for CD3_dep products and 5-hours for all other products

^†

Based on 25 of the 94 products that had post-depletion data collected prior to cytokine exposure

^‡

Lot release specification for NC dose increased from 3×10⁷/kg for CD3_dep and CD3_dep/CD56_enrich products to 8×10⁷/kg for CD3/CD19_dep products, thus increasing the total number of NK cells available for infusion

^ˠ

The cell processing time difference is attributed to concurrent cell depletion versus sequential depletion and enrichment. Cost includes cell processing supplies, lot release testing, and quality assurance review, with differences based on the number of columns and immunomagnetic bead reagents and technician time