Expediting development and manufacturing of advanced therapies: critical starting materials case studies

With upwards of 30 FDA-approved cell and gene therapy products to date, plus many on the horizon, plasmid DNA (pDNA) continues to play a crucial function within advanced therapies medicinal product (ATMP) development. Plasmids are commonly used both as direct therapeutic products and as critical starting materials where they contribute directly to the quality and function of mRNA and viral vector-based drug products. This article discusses the role of pDNA as a critical starting material and highlights the evolving regulatory guidance to safeguard pDNA programs. Case study examples will demonstrate expedited development and manufacture of ATMPs and highlight manufacturing and supply scenarios seen for plasmid starting materials alongside the strategies implemented to support rapid delivery while maintaining focus on end product quality.

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