Manufacturing chimeric antigen receptor T cells: issues and challenges.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 30685216.
- Also identified by DOI 10.1016/j.jcyt.2018.11.009.
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Abstract
Clinical trials of adoptively transferred CD19 chimeric antigen receptor (CAR) T cells have delivered unprecedented responses in patients with relapsed refractory B-cell malignancy. These results have prompted Food and Drug Administration (FDA) approval of two CAR T-cell products in this high-risk patient population. The widening range of indications for CAR T-cell therapy and increasing patient numbers present a significant logistical challenge to manufacturers aiming for reproducible delivery systems for high-quality clinical CAR T-cell products. This review discusses current and novel CAR T-cell processing methodologies and the quality control systems needed to meet the increasing clinical demand for these exciting new therapies.
Medical subject headings
- Immunotherapy, Adoptive
- Manufacturing and Industrial Facilities
- Neoplasms
- Quality Control
- Receptors, Chimeric Antigen