Quality by design in CAR-T and TCR-T manufacturing: engineering around variability and QC constraints

“Cell and gene therapy is evolving extremely quickly, and several areas are likely to transform the quality landscape over the next few years.”

Abi Pinchbeck, Editor, Cell & Gene Therapy Insights, speaks with Darshan Patel, Senior Quality Leader, Fred Hutchinson Cancer Center about the manufacturing and quality challenges associated with cellular immunotherapies, including variability in autologous starting materials, evolving quality control strategies, and the role of predictive analytics in shaping the future of cell therapy manufacturing.

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