Miltenyi Biotec has developed the CliniMACS Prodigy® as an all-in-one solution for cell processing in a closed GMP-compliant system⁴. The CliniMACS Prodigy enables the entire workflow for the manufacture of CAR T cells, from T cell selection through to cell formulation. Importantly, all cell processing steps are automated ensuring a highly reproducible and standardized manufacturing process. During the T cell Transduction Process (TCT Process), T cells are enriched by specific selection on day 0 (D0) and then activated overnight. On D1 T cells are transduced with a (lentiviral) vector. Subsequently, transduced T cells are expanded to the desired cell number for final cell formulation (D10–14).
For the manufacture and use of the engineered T cells, national and international legislation and regulations must be followed.
Miltenyi Biotec as the provider of the TCT Process does not give any recommendation regarding the use of the manufactured cells for therapeutic purposes and does not make any claim regarding a clinical benefit.
4. Apel, M. et al. (2013) Chemie Ingenieur Technik 85: 103–110