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Standardizing CAR-T therapy: Getting it scaled up
- Dai, Xiaofeng, Mei, Yi, Cai, Dongyan, Han, Weidong
- Biotechnology advances 2019 v.37 no.1 pp. 239-245
- T-lymphocytes, manufacturing, monoclonal antibodies, neoplasm cells, neoplasms, precision medicine
- CAR-T therapy, grafting the specificity of a monoclonal antibody onto a T cell to target certain cancer cells, has been recognized as a promising therapeutic approach for cancer control as evidenced by the two CAR-T products proved by FDA in 2017. However, the unique heterogeneity of CAR-T therapy has restricted its production in a limited number of institutions and made it a boutique oncotherapy. By reviewing outstanding issues surrounding the commercial scale production of CAR-T therapy, we conclude that achieving mass production of CAR-T therapy without sacrificing its personalized nature is a worldwild challenge for making CAR-T a key element in the next generation of precision medicine, which can be achieved by standardizing 7 prominent factors that collectively determine the scale of CAR-T manufacturing.