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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

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Overcoming Challenges for Engineered Autologous T Cell Therapies

Latest Advances in CAR-T Cell Manufacture & Clinical Developments

Marc Better, Vijay Chiruvolu & Marianna Sabatino

Axicabtagene ciloleucel is an engineered autologous anti-CD19 chimeric antigen receptor T cell therapy being developed for patients with refractory aggressive B-cell lymphoma. The product is manufactured in a central facility from cellular starting material containing a patient’s own T cells into which a chimeric antigen receptor transgene is directly introduced. This cellular starting material is highly variable from donor to donor and provides the single largest source of variability associated with the production process. Nonetheless, a robust manufacturing and distribution process was developed based on process understanding and appropriate process controls. Process characterization revealed process parameters that affect quality attributes, allowing appropriate control measures to be implemented. Process comparability criteria were also established as another mechanism to ensure process consistency as new manufacturing sites were introduced. A relationship between cellular characteristics of the incoming cellular starting material, cell growth and performance during manufacturing, and the ultimate product characteristics after administration to patients is also beginning to come into focus.

DOI: 10.18609/cgti.2018.014
Citation: Cell Gene Therapy Insights 2018; 4(4), 173-186.
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