Day One

• Defining pDNA as the gold-standard starting material for mRNA production to establish a stable, high-quality foundation for IVT efficiency across modalities
• Designing and scaling E. coli–based pDNA fermentation and purification workflows to deliver consistent quality from development through GMP manufacturing
• Linking pDNA purity, analytics, and impurity profiles directly to IVT fidelity to reduce downstream variability and dsRNA burden upfront
• Transferring pDNA process development into GMP facilities to ensure supply security and regulatory readiness at multiple production scales

• Positioning outsourcing as a quality and control decision, examining how choices around DNA templates, enzymes, buffers, consumables, and equipment directly shape drug substance robustness and downstream risk
• Defining fit-for-purpose outsourcing strategies across the lifecycle, from early development through scale-up and commercial readiness, and how expectations of external partners must evolve accordingly
• Critically assessing vendor capability beyond capacity, including process understanding, data transparency, change control, and the ability to support comparability and regulatory scrutiny

• Translating quality decisions made at the starting material and purification stages into GxP-ready assay development, validation, and high-containment preclinical datasets that regulators can rely on from early development through licensure
• Ensuring modality and platform diversification (mRNA, saRNA, circRNA; LNP and emerging delivery systems) is reflected in fit-for-purpose quality evidence packages, rather than relying on legacy or “standard” approaches that fail to capture platformspecific risks
• Defining what “right-first-time” quality confirmation looks like for assay strategy, comparability, and effectiveness evaluation, and how misalignment between process design and evidence generation drives late-stage rework

Our curated speed networking session is the perfect opportunity to meet and exchange information with every expert in the room. Spark in-depth conversations and forge long-lasting connections with fellow technical experts working within mRNA Process Development & CMC.

• Designing an integrated end-to-end RNA manufacturing system combining IVT synthesis, purification, formulation, and sterile filtration
• Incorporating inline monitoring sensors for real-time feedback and process control across continuous RNA workflows
• Lessons from the Innovate UK and CEPI-funded development programs, translating research-stage automation to GMP environments

• Engineering simplified, continuous mRNA workflows that shorten process steps and reduce cost of goods while maintaining GMP-grade quality
• Integrating synthetic DNA, continuous IVT, and inline analytics to enable faster release decisions and real-time process control
• Building resilient, scalable manufacturing platforms designed for rapid deployment, technology transfer, and equitable access across global settings