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

Table 3 Overall outcome of the CliniMACS CCS validation process for the manufacture of CMVpp65-specific T cells

*n = 3*	*%CD3* ⁺ *IFN-γ* ⁺ *recovery*	*%CD4* ⁺ *IFN-γ* ⁺ *recovery*	*%CD8* ⁺ *IFN-γ* ⁺ *recovery*	*%CD3* ⁺ *IFN-γ* ⁺ *purity*	*%CD4* ⁺ *IFN-γ* ⁺ *purity*	*%CD8* ⁺ *IFN-γ* ⁺ *purity*	*% total viability*
Mean	67.86	68.81	57.20	54.49	38.44	81.03	57.37
SD	22.66	57.20	23.42	31.88	27.98	15.75	1.61
Median	77.69	69.95	70.37	63.13	50.63	88.29	58.92
Min	41.94	11.04	30.16	19.18	6.43	62.96	51.13
Max	83.94	125.43	71.08	81.17	58.25	91.84	62.05

The recovery of IFN-γ⁺ T cells [%] in the products after large-scale CliniMACS CCS enrichment was calculated based on the CMVpp65_pp-stimulated original fraction (OF) and the final collected fractions (T-cell fraction (TCF), waste fraction (WF), negative fraction (NF), TCF after 48 h, 54 h, and 72 h post-leukapheresis (Stabi48, Stabi54, Stabi72)) as recovered from the CliniMACS tubing set. The result for the representative analysis of the recovery from the TCF is shown. The purity of IFN-γ⁺ T cells post-CliniMACS CCS enrichment was calculated as the percentage of CD3⁺CD56⁻ lymphocytes [%]. Total viability was assessed by 7AAD viability staining.

ISSN: 1479-5876