Conference Day Two: Thursday, 8th May
8:15 am Morning Coffee & Registration
9:15 am Chairs Opening Remarks
Optimizing 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 Optimising mRNA-LNP Drug Product Stability: Enhancing Quality & Reducing Aggregation for Clinical Readiness
Synopsis
- How can lyophilisation techniques be refined to preserve mRNA-LNP integrity and quality, ensuring regulatory compliance and extended shelf life?
- What role do nebulising agents play in reducing LNP aggregation post-formulation, and how can this improve stability for regulatory readiness?
- How can lipid composition and excipient selection be tailored to minimise particle size variability and maximise encapsulation efficiency for stable and reproducible drug products?
10:30 am Morning Break
Advancing LNP & Liquid Formulation Processes: Enhancing Stability, Scalability and Efficiency in mRNA Production for Global Access
11:30 am Fireside Chat: Addressing Formulation Challenges in Multivalent mRNA Vaccines: Ensuring Stability & Differentiation Across Strains
Synopsis
- How can formulation strategies ensure the compatibility and stability of multiple, highly similar mRNA sequences in a multivalent vaccine, minimising risks of degradation or loss of functionality?
- What role do advanced analytical techniques play in distinguishing and monitoring the stability of individual mRNA sequences with minimal differences, ensuring consistent quality across all components?
- How can excipient selection and LNP design be tailored to uniformly encapsulate and protect each mRNA molecule, reducing variability and improving efficacy?
- What preclinical and pre-formulation approaches can be applied to address stability challenges upfront, ensuring the success of multivalent vaccines during storage, transport, and administration?
12:30 pm Lunch
1:30 pm Liquid Formulation for mRNA: Simplifying Complexity in Manufacturing for Increased Patient Usability
Synopsis
- What predictive modelling tools are available to simulate and optimise liquid formulation workflows, minimising trial-and-error experimentation?
- How can liquid formulations improve cold-chain logistics and scalability while maintaining mRNA stability during transport and storage?
- How can automation reduce reliance on skilled labour and streamline liquid formulation processes during large-scale mRNA production?
Scaling mRNA Manufacturing: Seamless Transitions From Lab to Market to Ensure Consistent Quality for Meeting Growing mRNA Vaccine & Therapeutic Demands
2:00 pm Transitioning From Small-Scale Development to GMP Large-Scale Production to Meet Global Demands & Increase Patient Accessibility
Synopsis
- What are the key considerations for adapting GMP facilities and equipment to handle the increased complexity and scale of mRNA production?
- How can upstream processes, including buffer preparation, raw material handling, and mixing techniques, be optimised to ensure uniformity, prevent shear stress, and minimise contamination risks?
- What strategies can improve downstream purification and sterile filtration to maintain product quality, minimise dead volumes, and meet regulatory requirements?
2:30 pm Afternoon Break
3:00 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?
3:30 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?