The achievements of cell-based therapeutics have galvanized efforts to bring cell therapies to the market. To address the demands of the clinical and eventual commercial-scale production of cells, and with the increasing generation of large clinical datasets from chimeric antigen receptor T-cell immunotherapy, from transplants of engineered haematopoietic stem cells and from other promising cell therapies, an emphasis on biomanufacturing requirements becomes necessary. Robust infrastructure should address current limitations in cell harvesting, expansion, manipulation, purification, preservation and formulation, ultimately leading to successful therapy administration to patients at an acceptable cost. In this Review, we highlight case examples of cutting-edge bioprocessing technologies that improve biomanufacturing efficiency for cell therapies approaching clinical use.
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We thank a number of colleagues for feedback on a draft of the manuscript, specifically B. Hampson and T. Heathman from Hitachi Chemical Advanced Therapeutics Solutions. This work was supported in part by the Shriners Hospitals for Children (B.P.) and by the National Institutes of Health Grant R01EB012521 (B.P.).
A.A., M.L., O.S.F., D.K., M.V.M., J.R., J.T., R.M.O. and S.L. declare no competing interests. D.S., C.L. and R.P. are employees of Hitachi Chemical Advanced Therapeutics Solutions. R.D. owns equity in BlueRock Therapeutics. D.G.A. is a founder and equity shareholder in Siglion Therapeutics. R.N.B. is an employee and equity shareholder of Sentien Biotechnologies, Inc. B.P. is a founder and equity shareholder of Sentien Biotechnologies, Inc.
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Aijaz, A., Li, M., Smith, D. et al. Biomanufacturing for clinically advanced cell therapies. Nat Biomed Eng 2, 362–376 (2018). https://doi.org/10.1038/s41551-018-0246-6
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