Pre-Conference Workshop Day

From AI as a Tool to AI as a Co-Worker: Operationalising Augmented Intelligence and Automation to Optimise mRNA Development & CMC

As mRNA programmes scale in complexity and regulatory scrutiny, teams are under pressure to deliver faster, more robust development without increasing operational burden. While AI and automation are widely discussed, many organisations still struggle to translate these capabilities into practical, connected workflows that materially improve how work gets done across development and CMC.

Led by Pfizer and BioNTech, this workshop will explore how augmented intelligence and automation can be operationalised, enabling more efficient process development, stronger CMC alignment, and improved regulatory readiness. Attendees will gain insight into where AI and automation deliver immediate value, and how digitally enabled workflows can reduce friction while preserving quality and compliance.

• Reframing AI from point solutions to augmented workflows that materially change how mRNA teams operate across development, CMC, and regulatory preparation
• Exploring how low-code platforms, agentic AI, and workflow automation can compress timelines, reduce operational friction, and free scientists to focus on decision-making
• Identifying where AI delivers immediate value outside the lab, including regulatory readiness, documentation, submission quality, and cross-functional coordination

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