Rapid generation of clinical-grade antiviral T cells: selection of suitable T-cell donors and GMP-compliant manufacturing of antiviral T cells

Table 4 Analysis of product stability

Parameter	Validation run	TCF after enrichment	48 h		54 h		72 h
Parameter	Validation run		value	recovery	value	recovery	value	recovery
WBC	1. run	1.43x10⁷	9.60x10⁶	67.00%	7.80x10⁶	54.50%	7.60x10⁶	53.10%
	2. run	5.00x10⁶	4.40x10⁶	88.00%	4.20x10⁶	84.00%	4.00x10⁶	80.00%
	3. run	1.25x10⁷	8.60x10⁶	69.00%	7.30x10⁶	58.60%	6.50x10⁶	51.70%
viable WBC	1. run	1.01x10⁷	8.00x10⁶	79.50%	7.20x10⁶	71.60%	6.20x10⁶	61.70%
	2. run	3.40x10⁶	3.20x10⁶	94.10%	3.80x10⁶	>100%	3.60x10⁶	>100%
	3. run	6.00x10⁶	5.20x10⁶	85.70%	4.30x10⁶	71.40%	3.90x10⁶	64.30%
viable T cells	1. run	1.74x10⁶	1.42x10⁶	81.61	1.32x10⁶	75.86%	1.22x10⁶	70.11%
	2. run	2.97x10⁶	2.17x10⁵	73.06%	1.97x10⁵	66.33%	2.49x10⁵	83.84%
	3. run	1.83x10⁶	2.12x10⁶	>100%	1.85x10⁶	>100%	2.09x10⁶	>100%

Stability of the cells from the T-cell fraction (TCF) was analysed after 48 h, 54 h and 72 h post-leukapheresis with respect to total numbers of WBCs [x10⁶], viable WBCs [x10⁶] viable T cells (CD3⁺CD56⁻ T cells) [x10⁶], and recovery [%]. Detection of total cell numbers and viability was performed by light microscopy using trypan blue dye.

ISSN: 1479-5876