2 research outputs found
Cell therapy products: focus on issues with manufacturing and quality control of chimeric antigen receptor T-cell therapies
Recent accelerated approvals of Chimeric Antigen Receptor Tâcell (CARâT) therapies targeting refractory haematological malignancies underscore the potential for this novel technology platform to provide new therapeutic options for oncology areas with high unmet medical needs. However, these powerful âliving drugsâ are markedly different to conventional small molecule and biologic therapies on several levels. The highly complex nature and varied composition of CARâT based products still requires considerable investigation to resolve the best approaches to ensure reproducible and costâeffective manufacture, clinical development, and application. This review will focus on key issues for manufacturing and quality control of these exciting new therapeutic modalities, preceded by a brief description of CAR principals and clinical development considerations. © 2018 The Authors. Journal of Chemical Technology & Biotechnology published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry