SRNA operates a state-of-the-art contract development and manufacturing organisation (CDMO) specialising in the production of mRNA therapeutics and plasmid DNA (pDNA) template raw materials, supporting scalable manufacturing from research and development through to GMP production. As the DNA template is a critical raw material that directly influences the critical quality attributes (CQAs) of mRNA drug products, maintaining stringent quality standards throughout template production is essential.
This presentation describes the implementation and evaluation of a bench scale cell-free DNA template amplification technology within SRNA's established pDNA and mRNA manufacturing platform. The technology was assessed for scalability, product quality, and manufacturing compatibility relative to conventional plasmid-based template production. Initial studies have demonstrated encouraging performance, with significantly reduced template production timelines while maintaining DNA quality suitable for downstream mRNA manufacturing. Importantly, the process is compatible with existing manufacturing equipment and production workflows, enabling adoption with minimal additional capital investment. The reduced turnaround time further highlights the potential of this approach to support the rapid production timelines required for personalised mRNA therapeutics. Cell-free amplification reduces the production timeline to approximately two weeks, compared with the four to six weeks typically required for bacterial pDNA production.
Although these early results demonstrate considerable potential, further process development is required before GMP implementation. Current activities focus on improving process robustness across a wider range of construct complexities, optimising downstream purification, and applying design-of-experiment (DoE) approaches to enhance yield, consistency, and product quality. By leveraging existing manufacturing infrastructure while reducing turnaround times and production costs, this technology has the potential to support personalised mRNA therapeutic manufacturing.