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
- 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
9:30 am Roundtable Discussion: Rethinking mRNA Drug Substance Outsourcing: Designing Quality, Control & Scalability into External Manufacturing
- 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
10:00 am De-Risking mRNA Vaccines Through GxP Evaluation: Converting Designed-In Quality into Licensable Evidence
- 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
10:30 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
11:30 am Developing a Continuous, Automated, and Digitalised End-to-End RNA Manufacturing Platform
- 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
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 Rethinking Analytical Strategy for mRNA Products: Combining Ensemble Analysis with Single-Particle Insights to Strengthen CMC Robustness & Manufacturing Efficiency
- Developing analytical tools tailored to IVT reaction kinetics and RNA-specific impurity pathways to generate data that accurately reflects RNA process behaviour
- Evaluating the limitations of legacy biologics sensors and retrofitted platforms to build clearer justification for adopting purpose-built analytical systems
- How to embed fit-for-purpose analytical design into early process development to ensure method capability evolves with modality complexity and manufacturing scale
2:00 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
2:30 pm Leveraging Process Analytical Technologies to Enable Real-Time Control and Automation in mRNA Manufacturing
- Exploring strategies for implementing inline and online measurements to enable realtime mRNA process monitoring and optimization
- Lessons from CPI’s experience with PAT integration across different modalities and how these translate into mRNA workflows
- How emerging biofoundry approaches can accelerate analytical development and data-driven process design
3:00 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
4:00 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
4:30 pm Building Measurement Confidence for mRNA Products: Turning Analytics into Regulatory-Ready Decisions
- Defining measurement confidence for mRNA products: moving beyond analytical sensitivity to decision-ready, regulator-trusted evidence
- Translating analytical data into robust quality decisions across the mRNA lifecycle, from early development through clinical and commercial manufacturing
- Designing fit-for-purpose CQAs for mRNA, saRNA, and emerging RNA modalities without over-engineering analytical packages
- The role and limitations of reference materials, pharmacopeial methods, and interlaboratory comparability in building regulatory confidence
- Common CMC evidence pitfalls in mRNA programmes, including false precision, misaligned assay strategies, and late-stage rework — and how to avoid them
- Practical strategies for aligning analytics, process understanding, and regulatory
expectations to enable smoother scientific advice, review, and approval
5:00 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
5:30 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