Cell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies


Cell and gene therapy (CGT) products represent a frontier in modern medicine, offering precision treatments. Yet their development is affected by multifaceted challenges including chemistry, manufacturing, and controls (CMC). This article provides a comprehensive exploration of the complexities involved in CMC development and considers its role in establishing quality, safety and efficacy. 

We have endeavoured to explore the key elements of CMC pertaining to cell sourcing, vector development, manufacturing and control of drug products. Furthermore, we have delved into other critical factors such as raw materials/reagents selection, manufacturing process changes and comparability studies. This article also highlights the need for sponsors to periodically revisit the product development strategy to be in line with clinical development.

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