Steven L Highfill1, David F Stroncek2. 1. Center for Cellular Engineering, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, MD, USA. steven.highfill@nih.gov. 2. Center for Cellular Engineering, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Abstract
PURPOSE OF THE REVIEW: Cellular therapy using chimeric antigen receptor (CAR) T cells as a treatment option for patients with lymphoma and leukemia has proven to be remarkably efficacious. This success has sparked the development of new cellular therapy products for numerous indications. Similar to pharmaceutical products, challenges exist at nearly every stage of process development; however, the unique nature of a cellular therapy product can present exceptional challenges that are just beginning to emerge. The purpose of this review is to explore some of the most common challenges experienced during the early phases of development of CAR T cell products and to provide suggestions for navigating these challenges. RECENT FINDINGS: Recent articles focused on CAR T cells are highlighted with special attention on aspects that relate to CAR T cell process development and clinical manufacturing. We examine the various stages of process development for CAR T cells and outline some of the obstacles that must be overcome in order to move from pre-clinical development into clinical manufacturing. As the field of CAR T cell therapy continues to grow, it is important to quickly move new CAR T cell products into and through early phase clinical trials and to ensure that the result of these trials can be adequately compared. Having laboratory and clinical investigators and GMP manufacturing facilities aligned on the numerous aspects of new product development will facilitate this process.
PURPOSE OF THE REVIEW: Cellular therapy using chimeric antigen receptor (CAR) T cells as a treatment option for patients with lymphoma and leukemia has proven to be remarkably efficacious. This success has sparked the development of new cellular therapy products for numerous indications. Similar to pharmaceutical products, challenges exist at nearly every stage of process development; however, the unique nature of a cellular therapy product can present exceptional challenges that are just beginning to emerge. The purpose of this review is to explore some of the most common challenges experienced during the early phases of development of CAR T cell products and to provide suggestions for navigating these challenges. RECENT FINDINGS: Recent articles focused on CAR T cells are highlighted with special attention on aspects that relate to CAR T cell process development and clinical manufacturing. We examine the various stages of process development for CAR T cells and outline some of the obstacles that must be overcome in order to move from pre-clinical development into clinical manufacturing. As the field of CAR T cell therapy continues to grow, it is important to quickly move new CAR T cell products into and through early phase clinical trials and to ensure that the result of these trials can be adequately compared. Having laboratory and clinical investigators and GMP manufacturing facilities aligned on the numerous aspects of new product development will facilitate this process.
Entities:
Keywords:
CAR T cells; Cellular therapy; GMP manufacturing; Process development
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