The enrichment of clinical-grade antigen-specific T cells from suitable donors is performed aseptically under GMP-compliant conditions using the IFN-y CliniMACS Cytokine Capture System (CCS) and GMP-grade peptide pools of an immunogenic protein. The manufacturing license for generating clinical grade mono- and multi-virus specific T-cell products was obtained in accordance with the German Medicines Act in March 27th, 2014.
The initial T-cell donor search is done by screening for antiviral T cells in stem cell, a haploidentical family, or (partially) HLA-matched unrelated third party donors from the alloCELL registry. T-cell donors are defined as eligible when seropositive and ≥0.01-0.03% specific IFN-γ+ T cells are detectable. If the stem cell donor or a family donor is not eligible, a related or at least 5/10 HLA matched alloCELL donor is chosen.
Highly effective clinical-grade T-cell units are in-time manufactured under GMP.
To date more then 450 mono- and multivirusspezific T-cell units have been generated for application in patients.