Regenerative Medicine Vol. 15 No. 12 | Commentary

Development of a closed and automated bioreactor technology for cell therapy manufacturing – a sharing of our journey

Summary

Cell therapy uses live cells to treat diseases. For example, chimeric antigen receptor T cells (CAR-T) are T cells that have been engineered to express CARs to produce a cytotoxic effect against cancerous cells that express the targeted antigen [1]. Epstein–Barr virus-specific T-cell therapies are produced by stimulating naive T cells with Epstein–Barr virus-transformed lymphoblastoid cell lines (LCLs) [2].

As more cell therapies are progressing to clinical trials, with 1052 clinical trials underway worldwide in 2019 [3], several manufacturing challenges have emerged. At the same time, the approval of Kymriah and Yescarta by the US FDA in 2017 initiated many conversations on the bottlenecks in the manufacturing of cell therapy products [4–6]. These bottlenecks include high dependence on skilled labor and lack of automated options for cell processing. Our research lab based in the Agency for Science, Technology and Research (A*STAR), Singapore focuses on technologies for improving manufacturing process and efficiency for applications in cell therapy and regenerative medicine. With 4 years of research and development, we have successfully developed a patent pending bioreactor technology to address some of the bottlenecks of cell therapy manufacturing.

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