A Rapid Cell Expansion Process for Production of Engineered Autologous CAR-T Cell Therapies.

ABSTRACT: The treatment of B-cell malignancies by adoptive cell transfer (ACT) of anti-CD19 chimeric antigen receptor T cells (CD19 CAR-T) has proven to be a highly successful therapeutic modality in several clinical trials.^1-6 The anti-CD19 CAR-T cell production method used to support initial trials relied on numerous manual, open process steps, human serum, and 10 days of cell culture to achieve a clinical dose.⁷ This approach limited the ability to support large multicenter clinical trials, as well as scale up for commercial cell production. Therefore, studies were completed to streamline and optimize the original National Cancer Institute production process by removing human serum from the process in order to minimize the risk of viral contamination, moving process steps fr

SUBMITTER: Lu TL 

PROVIDER: S-EPMC6445175 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature