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 Optimizing 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 Roundtable Discussion – 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?
1:00 pm Lunch
2:00 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
2:30 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?