Cell and gene therapy (CGT) has evolved from a niche research pursuit into a central force in biopharmaceutical innovation. By engineering living cells and genetic material to repair or replace faulty biological mechanisms, these therapies can deliver outcomes that traditional drugs cannot achieve. Still, manufacturing remains fragmented and highly variable, with most processes still reliant on manual intervention and legacy systems, slowing progress toward scalability.

The growing use of advanced analytics and artificial intelligence (AI) is reshaping this landscape by enabling data-driven process control, predictive manufacturing, and greater transparency across the development lifecycle. Together, these tools are creating the foundation for scalable, reproducible, and compliant CGT man

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