Cell therapy analytics and CMC: balancing innovation with standardization

Cell and gene therapies (CGTs) are reshaping modern medicine, with more than 45 FDA-approved products to date [1] [2] [3]. Yet while clinical impact has grown, the analytical and CMC frameworks that support these therapies lag behind. Manufacturing variability, donor-to-donor differences, lengthy assay turnaround times, high reagent costs, and reliance on manual workflows continue to challenge reproducibility and scalability. Emerging solutions—process analytical technology (PAT), AI/ML, and integrated manufacturing systems—offer hope, but regulatory confidence and harmonized standards remain essential. This commentary reflects on current bottlenecks, highlights promising innovations, and calls for collaborative strategies to align scientific advances with practical realities.

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