The cell therapy industrial revolution: current successes, existing challenges, and expansion into new domains

Cell therapies continue to demonstrate their clinical success in the oncologic realm. The field has developed significantly from the initial hematopoietic stem cell transplants over a half century ago through the curative potential of single treatment CAR-T therapies, to the most recent regulatory approvals for the first CRISPR gene-edited hematopoietic stem cell (Casgevy®) and first tumor infiltrating lymphocyte therapy for solid tumors (Amtagvi™). The expedited success of these relatively new modalities validates that industrialization is still lagging. Widespread platform production methods are challenging due to the differing biological, scale, and platform requirements that are highly dependent on cell type and disease indication. Addressing these challenges will enable developers to better focus on reaching patients, rather than continually re-establishing new manufacturing paradigms. Continued forward progress will ensure that the field will enter an even more productive phase within oncology and beyond to areas such as autoimmune disease once the current field and market challenges abate.

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