Adithya Nair

Integrating IVT and Continuous Oligo-dT Purification to Enable Low- Cost, High-Quality mRNA Drug Substance Manufacturing

As mRNA drug substance manufacturing evolves beyond early clinical supply, purification is emerging as a critical lever for both cost control and product quality. Traditional batch-based IVT and downstream purification workflows introduce avoidable material losses, extended processing times, and challenges in maintaining consistency at scale. Led by the University of Sheffield, this workshop will examine how integrating IVT with continuous oligo-dT–based purification can streamline drug substance production into a single, connected operation. Attendees will gain practical insight into how capture-based purification during or immediately post-IVT supports higher purity, improved consistency, and scalable manufacturing while maintaining regulatory robustness.

• Redesigning IVT–purification workflows as a single, integrated unit operation to reduce material loss, processing time, and overall cost of goods
• Leveraging oligo-dT–based capture during or immediately post-IVT to improve mRNA purity, consistency, and removal of truncated species and impurities
• Evaluating how integrated purification strategies support continuous and scalable manufacturing without compromising drug substance quality or regulatory robustness