Explore the Agenda
8:00 am Morning Breakfast & Registration
8:55 am Chair’s Opening Remarks
Designing Quality into mRNA from Day One: Starting Materials, Purification & GxP Evidence
9:00 am Optimising pDNA as a Starting Material to Enable Robust, GMP-Ready mRNA Manufacturing
- Defining pDNA as the gold-standard starting material for mRNA production to establish a stable, high-quality foundation for IVT efficiency across modalities
- Linking pDNA purity, analytics, and impurity profiles directly to IVT fidelity to reduce downstream variability and dsRNA burden upfront
- Designing and scaling E. coli–based pDNA fermentation and purification workflows to deliver consistent quality from development through GMP
9:30 am Enhancing IVT Performance and Product Quality with synthetic oDNA
- Learn how synthetic oDNA from Syngoi is helping to reduce delivery times, increase mRNA yield and Quality and reduces the cost per dose by 25%
- With our Pure Synthetic Approach, can deliver high quality fully synthetic DNA in weeks, from scratch
9:45 am Roundtable Discussion: Rethinking mRNA Drug Substance Outsourcing: Designing Quality, Control & Scalability into External Manufacturing
- Positioning outsourcing as a strategic quality and control decision, assessing how choices around pDNA, enzymes, lipids and consumables directly influence mRNA drug substance robustness, impurity burden and downstream manufacturability
- Defining fit-for-purpose outsourcing strategies across development stages, evaluating how expectations of CDMOs and external partners must evolve from early research through GMP scale-up and commercial readiness
- Critically assessing external manufacturing partners beyond capacity, including process understanding, analytical transparency, comparability support and readiness for increasing regulatory scrutiny
10:15 am Morning Break & Speed Networking
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.
Modernising mRNA Manufacturing to Enable Scalable, Integrated & Continuous Production
11:20 am Redesigning mRNA Drug Substance Manufacturing: Integrating IVT & Continuous Oligo-dT Purification to Reduce Cost & Improve Quality
- Designing an intergrated end-to-end RNA manufacturing system combining IVT synthesis, purification, formulation and sterile filtration
- Evaluating how integrated purification strategies support continuous and scalable manufacturing without compromising drug substance quality or regulatory robustness
- Lessons from the Innovate UK and CEPI-funded development programs, translating research-stage automation to GMP environments
11:50 am Key CMC Considerations For Mrna Therapeutics Towards Ind Approval
- Deciphering end-to-end mRNA therapeutic workflows that underpin CMC readiness for IND
- Prioritizing key CMC considerations across materials, process development, and controls for IND submission
- Showcasing CATUG Biotechnology’s one-stop CMC service to streamline development toward filing
12:00 pm CEPI Playbook: Designing Continuous mRNA Manufacturing Platforms to Reduce Cost, Increase Speed & Enable Global Access
- 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
12:30 pm Lunch Break
Building Analytical Readiness to Strengthen Long-Term CMC Robustness
1:30 pm Analytical Readiness for mRNA therapeutics: Defining, Measuring & Assessing Quality
- Defining fit-for-purpose critical quality attributes (CQAs) for mRNA drug substance and drug products to support consistent quality assessment as programmes progress from early development into the clinic
- Comparing established and emerging analytical technologies used to assess mRNA therapeutics quality and batch consistency to highlight practical strengths, limitations and areas of divergence across current industry practice
- Identify gaps in analytical technologies for quality assessment of mRNA therapeutics
2:00 pm Streamlining mRNA Production: Enhancing Yield and Purity through the AMCAP™ Enzymatic Capping Evolution
- Innovative One-Pot mRNA Synthesis
- Scalable Path from R&D to GMP
- Optimized Process Efficiency & Performance
2:10 pm Afternoon Break & Poster Session
Contribute to the conversation and showcase your cutting-edge research to the entire room, with like-minded mRNA Experts. To present a poster, register your place and submit an abstract highlighting your breakthroughs. Please visit the website for T&Cs for presenting a poster.
Navigating Evolving Regulatory Frameworks to Build Confident, Modality-Ready mRNA CMC Strategies
3:00 pm Benchmarking Regulatory Strategies in an Uncertain Landscape: How Biotech & Pharma are Approaching mRNA Quality, Risk & Engagement
- Comparing how biopharma interprets evolving guidance across potency, impurities and raw materials to apply risk-based, platform approaches to maintain compliance and product quality while progressing mRNA programmes
- Examining processes, cross-functional review structures and escalation pathways used by industry to adjudicate regulatory grey zones and establish consistent, inspection-ready quality decision
3:30 pm Embedding European Pharmacopoeia mRNA Standards into CMC & Process Strategies to Ensure Harmonised Quality
- Adapting test methods, acceptance criteria and reference standards to meet European Pharmacopoeia expectations without overburdening development resources
- Assessing how evolving European Pharmacopoeia content interacts with MHRA, EMA and other agency expectations to build a coherent, Europe-ready CMC framework
4:00 pm Aligning mRNA Quality & CMC Strategies with Evolving European Regulatory Expectations
- Interpret how draft mRNA guidelines and ATMP frameworks are shaping regulator expectations for quality, control strategies, and CMC robustness
- Understand how quality considerations are evolving as mRNA applications diversify across indications, modalities, and delivery approaches
- Learn how early scientific advice and engagement with authorities can be used to strengthen CMC packages and de-risk development pathways