Conference Day One: Wednesday, 7th May
8:00 am Morning Coffee & Registration
8:55 am Chair’s Opening Remarks
Enhancing End-to-End mRNA Process Development With New mRNA Technologies to Increase Purity and Scalability of mRNA Drugs for Safeguarding Approvals
9:00 am The mRNA Printer® – A Highly Automated Solution for Agile & Fast Manufacturing of Small-Scale Personalised Therapies
Synopsis
- How can transportable and automated printing platforms, such as RNA printers, enable decentralised mRNA production for rapid therapeutic deployment?
- What role does printing play in creating customised components, such as bioreactor parts and microfluidic devices, to enhance efficiency and reduce material waste in mRNA workflows?
- How can printed tools, such as improved mixing chambers or filtration units, optimise raw material utilisation by reducing waste, enhancing process consistency, and ensuring uniform mRNA production at scale?
9:30 am Advancing Self-Amplifying RNA to Minimise Raw Material Use for Reduced Dosage Needs and Expanded Therapeutic Applications
Synopsis
- How can Self-Amplifying RNA’s (saRNA) self-replicating mechanism enable the production of higher protein levels per dose, significantly lowering the initial raw material requirements compared to conventional mRNA?
- How does the prolonged protein expression driven by saRNA elicit robust immune responses with smaller doses for minimising material usage while maintaining therapeutic efficacy?
- How can the scalability and versatility of saRNA support its use across vaccines and therapeutics, reducing the strain on raw material supply chains for broad deployment?
10:00 am Morning Break & Speed Networking
Advancing mRNA Purification Process Development to Enhance mRNA Drug Product Quality for Reliable Regulatory Success
11:00 am Continuous Product Extraction: Maximising Raw Material Usability in mRNA Processes to Achieve Sustainable Manufacturing
Synopsis
- How can continuous extraction of unused raw materials, such as co-capping enzymes, improve resource efficiency and reduce costs in mRNA manufacturing for scalable, sustainable production?
- What technologies enable real-time separation of by-products to reduce downtime for reliable manufacturing of mRNA therapeutic and vaccine production?
- How can continuous product extraction contribute to the transition from batch to continuous mRNA manufacturing workflows?
11:30 am Session Reserved for Vazyme
12:00 pm Filtration-Only Purification: Streamlining mRNA Manufacturing Beyond HPLC for Cost-Effective and Time-Efficient Solutions
Synopsis
- What are the key considerations for implementing filtration-only purification to remove dsRNA and impurities effectively?
- How can filtration-only systems reduce process complexity and operational costs in mRNA production?
- What challenges must be addressed to ensure filtration-only purification meets regulatory standards for mRNA quality and safety?
12:30 pm Lunch Break & Networking
1:30 pm Continuous Purification: Enhancing Efficiency to Deliver Consistent Product Quality, Reduce Costs, and Meet the Growing Global Demand for mRNA Therapeutics and Vaccines
Synopsis
- How can continuous purification systems improve process efficiency and reduce time-to market for mRNA therapeutics?
- What strategies ensure consistent removal of impurities like dsRNA and unreacted nucleotides in continuous purification workflows?
- How does continuous purification support scalability and integration into end-to-end mRNA manufacturing processes?
2:00 pm Reserved for Inofea
Turning Regulatory Uncertainty Into Opportunity: Aligning End-to-End mRNA Process Development With New Guidelines for Approval Success
2:10 pm Fireside Chat: Bridging the Gap Between Manufacturing & Regulatory Requirements for mRNA Platform Success
Synopsis
- How can mRNA platform capabilities be strategically mapped to streamline regulatory pathways and support the approval of subsequent products?
- How to leverage the learnings from approved mRNA technologies to facilitate a more straight-line development route with future pipelines?
- How to navigate new guidelines as a pre-approved mRNA drug developer to facilitate faster approvals while ensuring compliance with evolving standards?
- What are the regulatory guidelines and compliance challenges for traditional versus non-traditional mRNA therapeutics?
3:10 pm Afternoon Break & Poster Session
Building Robust CMC Processes for novel mRNA modalities to Enhance Quality and Stability
4:10 pm Reserved for Syngoi
4:20 pm Improving mRNA Stability Through Enhanced Circular RNA CMC Processes for Scalable Manufacturing
Synopsis
- How to leverage the first circular mRNA IND approval to refine stabilisation techniques in line with regulatory requirement to achieve approvals with novel modalities?
- How to adapt current mRNA stabilization techniques to meet the unique requirements of circular RNA, ensuring seamless stabilisation into therapeutic pipelines for increased patient use?
- How to streamline circular RNA production processes, addressing stability challenges while maintaining cost efficiency and quality at GMP standards?