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Release Assays and Potency Assays for CAR T-Cell Interventions
Juliana Dias1,2, Amaia Cadiñanos-Garai3, Claire Roddie4,5
1UCL Cancer Institute, University College London, London, UK. j.pinto@ucl.ac.uk.
Advances in Experimental Medicine and Biology
|May 31, 2023
Summary
Chimeric antigen receptor (CAR) T-cell therapy offers a promising cancer treatment. This chapter discusses essential manufacturing assays for CAR T-cells, addressing quality, scalability, and safety challenges.
Area of Science:
- Immunology
- Biotechnology
- Oncology
Background:
- Chimeric antigen receptor (CAR) T-cells are engineered immune cells offering a novel cancer therapy.
- CAR T-cells function by targeting specific cancer antigens, acting as 'living drugs'.
- Manufacturing CAR T-cells presents challenges in quality control, scalability, and cost-effectiveness.
Purpose of the Study:
- To discuss the critical release and potency assays for CAR T-cell manufacturing.
- To address the challenges in ensuring product consistency and quality.
- To explore future perspectives in CAR T-cell assay development.
Main Methods:
- Review of current CAR T-cell manufacturing processes.
- Analysis of existing release and potency assays.
- Discussion of challenges in scalability and product variability.
Main Results:
- CAR T-cell manufacturing requires robust assays to ensure product quality and consistency.
- Balancing product quality with scalability and cost is a major hurdle.
- New safety considerations arise with allogeneic T-cells and genome editing.
Conclusions:
- Establishing critical quality attributes and reliable assays is crucial for CAR T-cell certification.
- Overcoming manufacturing challenges is key to widespread clinical adoption.
- Future work should focus on innovative assays addressing safety and efficacy.
