Product-safety considerations in allogeneic chimeric antigen-receptor T-cell process flows

Allogeneic chimeric antigen-receptor T-cell process flows comprise large-scale primary cultures incorporating traditional biologics processing steps such as cell expansion, with novel processing steps such as electroporation. In addition, these process flows begin with donor-derived peripheral blood mononuclear cells and generate single batches of product, which may be used to treat hundreds of patients. The corresponding unit operation-process safety considerations are individually diverse, and in combination are currently unique and rapidly evolving. The use of available regulations and the principles of quality by design are useful in designing appropriate control strategies into the process during development to ensure process safety.

Automated summary

Allogeneic chimeric antigen-receptor T-cell processes involve large-scale cultures and novel processing steps, starting with donor-derived peripheral blood mononuclear cells and generating products for hundreds of patients. The safety considerations are diverse and unique, and the use of regulations and quality design principles is important in ensuring process safety.