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Figure 1 | Journal of Translational Medicine

Figure 1

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

Figure 1

Protocol for the rapid manufacture of clinical-grade antigen-specific T cells. A three-step protocol for the rapid generation of clinical-grade antiviral T cells was established to facilitate the manufacture of specific T cells for adoptive transfer in pre-monitored patients. First Step: Selection of potential T-cell donors from the alloCELL registry (HLA type, virus serology and virus-specific T-cell response). Second Step: Verification of the donor’s specific T-cell frequencies (donor from alloCELL, stem cell or family donor) and prediction of the donor’s T-cell enrichment efficiency by small-scale MiniMACS CSA. A T-cell donor is classified as eligible if (a) the peripheral frequency of virus-specific IFN-γ+ T cells ≥0.03% of total CD3+ T cells and (b) the restimulation efficiency is twice as much as the unstimulated control. Third Step: Manufacturing of clinical-grade antiviral T cells by large-scale CliniMACS CCS. A CliniMACS CCS-enriched T-cell fraction (TCF) is classified as eligible if (a) number of viable IFN-γ+ T cells >1 × 104 and (b) the number of viable IFN-γ T cells ≤2 × 107.

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