The Importance of Collection, Processing & Biopreservation Best Practices in Determining CAR-T Starting Material QualityPublished: May 29, 2018
Latest Advances in CAR-T Cell Manufacture & Clinical Developments
Lou Juliano, George Eastwood, Todd Berard & Aby J Mathew
The approval of several CAR-T cell therapies highlights the ongoing transition of cell-based therapeutics from clinical trial to commercialization. This transition stage is difficult at the best of times, encompassing a shift from small- to large-scale drug production while maintaining product safety and efficacy. Cell therapy presents a unique challenge not extant to traditional medical treatments. Living cells embody an intrinsic variability of response and function that can impact their efficacy in a patient. It is important that pharmaceutical companies take pains to optimize their production workflow from the beginning, to ensure an effective and reliable product. The need for high-quality starting material is crucial to success, since the number of healthy cells in leukapheresis-derived starting material directly impacts the efficacy of the final product. In this article, we examine the processes that ensure optimal quality of the material that forms the basis of CAR-T therapies.DOI: 10.18609/cgti.2018.032
Citation: Cell Gene Therapy Insights 2018; 4(4), 327-336.