Avoiding Stops and Overcoming Roadblocks: Considerations for Improving Patient Access to CAR-Based Cell Therapies.

Abstract

Adoptive cell therapy has significantly impacted the immuno-oncology landscape. The number of strategies currently in preclinical and clinical development is increasing at a rapid rate. Indeed, we are experiencing a transformative movement in cancer care as we shift toward highly personalized treatments designed to confront the specific challenges of each cancer. Advancements in genetic engineering methods and single-cell profiling technologies provide a level of understanding of the interactions between the immune system and cancer never before achieved. This knowledge, in turn, can be applied to the design and engineering of effective cancer-fighting treatments. As these promising new therapies progress toward clinical application, it becomes evident that we must develop robust methods for production and validation of cellular products to ensure consistency, safety, and efficacy, irrespective of cell type or indication. Herein, we provide an overview of the innovative approaches guiding the new generation of cell therapies and describe the benefits and challenges associated with emerging autologous and allogeneic platforms. Moreover, we discuss important considerations pertaining to process development, cost of goods, and manufacturing, and highlight their impact on the transfer of therapies from bench to bedside.