Day Two | Thursday, 8th May
8:15 am Morning Coffee & Registration
9:15 am Chairs Opening Remarks
Optimising mRNA Stabilisation Techniques to Bridge The Gap Towards Room Temperature Storage for Improved Patient Accessibility
9:30 am Enhancing mRNA Drug Substance Stability: Advancing Thermostability Towards the Gold Standard of Room Temperature Storage
Synopsis
- How can optimizing UTRs and stem loops stabilise mRNA secondary structure to enhance thermostability for increased scalability?
- How can modified nucleosides be used to improve stability for increased storage capacity?
- How can cap analogues and optimized poly(A) tails be incorporated to enhance mRNA integrity and prolong stability during storage?
- How have companies achieved mRNA drug storage at 2-8 degrees and how can this be leveraged for drug candidates?
10:00 am Reserved for Donaldson Life Sciences
Synopsis
Session Details to be Announced
10:10 am Morning Break
Advancing LNP & Liquid Formulation Processes: Enhancing Stability, Scalability and Efficiency in mRNA Production for Global Access
11:30 am Optimising the Upstream Drug Substance Process to Increase Yield, Enhance Purity, and Streamline Scalability in mRNA Manufacturing
Synopsis
- How to intensify the upstream process to maximize mRNA yield while maintaining efficiency and consistency.
- How to optimize reaction conditions to minimize impurities like dsRNA and improve overall mRNA purity.
- How to scale up IVT reactions to ensure seamless tech transfer from clinical to commercial production.
12:00 pm Development of an innovative drug delivery system : the case of xPhore™ platform for RNA delivery
Synopsis
- Showcasing an adaptable carrier that delivers diverse RNA modalities including mRNA, circRNA, and oligonucleotides.
- An alternative solution to viral and non-viral delivery systems for RNA, based on peptide nanoparticles, void of lipids and PEGylation, with simpler CMC process and product strategy.
- The importance of orthogonal approaches to nanoparticle characterisation, increasing product knowledge and maintaining cost effectiveness.
1:00 pm Lunch
Scaling mRNA Manufacturing: Seamless Transitions From Lab to Market to Ensure Consistent Quality for Meeting Growing mRNA Vaccine & Therapeutic Demands
2:00 pm End-to-end microfluidic manufacturing of personalized cancer treatments
Synopsis
- Single-use biochips eliminate patient-to-patient risk of cross-contamination
- Personalized manufacturing and release process with NMU-Symphony™
- From RNA-design to patient-injectable vials in 3 weeks
2:30 pm Optimising mRNA Manufacturing & Process Development to Accelerate Time to Market for Disease X & Beyond
Synopsis
- How to leverage existing knowledge from established vaccine families and data, to optimise preparedness and streamline process development for new disease indications or in response to Disease X?
- How can the transition from batch to continuous manufacturing eliminate the need for traditional scale-up by adjusting production run times to meet diverse therapeutic demands, from personalised therapies to large-scale pandemic responses?
- How can challenges such as process initialisation, step synchronisation, and realtime quality monitoring during the transition from batch to continuous manufacturing be addressed to ensure consistent operation, enhance scalability, and accelerate timelines?
3:00 pm Streamlining Tech Transfer in mRNA Manufacturing to Minimise Disruptions for Smooth Transition to Large-Scale Production for Global Market Delivery
Synopsis
- How can process knowledge and data from small-scale development be effectively transferred to GMP facilities to ensure consistency at scale?
- What are the best practices for managing variability in equipment, raw materials, and personnel expertise during tech transfer?
- How can a standardised tech transfer framework minimise risks and delays while maintaining compliance and product quality?