Production and Quality Control of CAR-T Cells
SHI Lin, WANG Yongzeng, LÜ Lulu*
CAR-T (chimeric antigen receptor T-cell) therapy is a novel form of immunotherapy with significant breakthroughs achieved in hematologic malignancies in recent years. Additionally, remarkable progress has been made in the treatment of autoimmune diseases and solid tumors. The manufacturing process of CAR-T cell products is complex, and standardization of production and quality control processes is crucial to ensure the safety and efficacy of the therapy. This article provides a detailed description of the production process for CAR-T cell products, including materials, manufacturing models, equipment, and process development, as well as quality control. Furthermore, based on clinical experience, the article discusses ongoing developments of CAR-T cell technologies and analysis methods, offering valuable insights for professionals in the field to promote the standardization of the development of CAR-T cell therapy.
CN
EN