8:30 am Morning Welcome Coffee
9:30 am Chair’s Opening Remarks
Addressing the Current Innovative Approaches for Increased LNP Stability & Characterisation to Enhance Efficacy & Explore Targeted Delivery
9:30 am Deciphering LNP-mRNA Vaccines Characterisation with Advanced Asymmetric-Flow Field-Flow Fractionation & Size Exclusion Chromatography Techniques
Synopsis
- Drug substance and drug product characterisation using multi-detection
- From mRNA oligomeric state and conformation investigation to LNP stability studies
- LNP payload analysis and limitations
10:00 am Roundtable Discussion: How to Create a Reference Document to Facilitate Smooth Approval of mRNA Therapeutics in Compliance with Industry Regulations
Synopsis
- Delving into how to give evidence of a state of control and maintain regulatory compliance for your mRNA analytical techniques
- Unveiling strategies to incorporate innovative mRNA analytical technologies in alignment with GMP guidelines
- Understanding the process of standardizing mRNA analytical techniques to conform to CQAs and CPIs, thereby enabling efficient and expeditious approval
11:00 am Morning Break & Speed Networking
Explore the Latest Advancements & Methodologies in Development of Functionally Relevant Potency Assays to Ensure Safety & Accurate Results
12:00 pm Exploring the Development & Optimisation of mRNA Delivery Systems to Advance mRNA Therapeutics
Synopsis
- Delving into the possible methods of characterizing your mRNA delivery systems to understand their performance under different conditions
- Focusing on how to optimise the interaction between your mRNA delivery systems and cellular machinery that can lead to degradation of the mRNA to improve the stability and efficacy of mRNA delivery systems
- Addressing the challenges of achieving targeted delivery of mRNA therapeutics to specific tissues or cells
Virtual Presentation
12:30 pm Life-cycle Approach of Cell-Based Assays to Support Drug Development of RNA Therapeutics
Synopsis
- Properties and biological characterisation of “non-biologic” biologics (e.g., peptide and protein fusions and conjugates) – can we translate learnings to RNA-based therapeutics?
- Potency assays for lot release of RNA therapeutics vs biological assays to support other RNA drug development activities (comparability, process development and formulation screening)
1:00 pm Networking Lunch
Expanding the Analytical Toolbox to Support Process Development & Exploring the Introduction of Digitalization in Production to Ensure Security & Compliance
2:00 pm Navigating Challenges in the Scale-Up of siRNA Production: Insights from Discovery to Development
Synopsis
- What are cross learnings with mRNA and siRNA production?
- What are the stability and delivery challenges at larger production scales for siRNA
- How can you optimize RNA production?
2:30 pm Unveiling the Next Generation of mRNA Analytical Development to Revolutionize the Current Analytical Toolbox
Synopsis
- Highlighting the benefits and prospects of novel analytical and biological technologies compared to conventional approaches
- Drawing cross-learnings from different systems to overcome overlapping challenges and improve the analytical
- Learning from diverse platforms to address shared hurdles and enhance analytical strategies
- How the current techniques can be generated from covid vaccines into cancer vaccine