Engineering of afami-cel
Afami-cel was engineered using the Adaptimmune p1.5, p1.5.1 and p1.6.1 manufacturing processes. The p1.5 process used the COBE 2991 Cell Processor cell washer (Terumo BCT) and Xuri Cell Expansion System W25 bioreactor (Cytivia). During the trial, process improvements were made to the volume of material processed, with the process being updated to p1.5.1. Further improvements were made during the trial, with the COBE 2991 Cell Processor being replaced by the Sepax C-Pro Cell Processing System (Cytivia) for the p1.6.1 manufacturing process. Along with changes to the cell manufacturing process over the course of the trial, there were also multiple sources of lentiviral vector. The initial source of vector was manufactured by City of Hope and used an adherent-based manufacturing process. The lentiviral vector sourced later in the trial was manufactured by Lentigen and used a suspension-based manufacturing process. The median vector copy number in the product was 4.5 per transduced cell (range, 2.2–8.5 per transduced cell); the median transduction efficiency for the product was 53.3% (range, 25.5–80%); and the median number of cells produced during the manufacturing process was 20.7 × 10