Conference Day Two

Thursday 29th August, 2024

8:30 am Morning Welcome Coffee

9:00 am Chair’s Opening Remarks

Addressing The Current Innovative Approaches for Increased LNP Stability & Characterisation to Enhance Efficacy & Explore Targeted Delivery

9:30 am Exploring the Development & Optimisation of mRNA Delivery Systems to Advance mRNA Therapeutics

  • Ajit Magadum Associate Scientist, Temple University College of Science & Technology


  • Delving into the possible methods of characterising 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

10:00 am Deciphering LNP-mRNA Vaccines Characterisation with Advanced Asymmetric-Flow Field-Flow Fractionation & Size Exclusion Chromatography Techniques

  • Marco Morani mRNA Analytical Development and Characterisation Scientist, Sanofi


  • 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

10:30 am Morning Break & Speed Networking

Explore the Latest Advancements & Methodologies in Development of Functionally Relevant Potency Assays to Ensure Safety & Accurate Results

11:30 am Developing Different Types of Potency Assays to Measure Contaminants & Bioreactivity of mRNA-based Therapeutics to Ensure Safety for Patients

  • Robert Place Senior Vice President - Innovation, MiNA Therapeutics


  • Investigating the development of novel purity assays to improve the efficacy of mRNAbased therapeutics
  • Exploring the development of different types of potency assays that can accurately measure the bioreactivity of mRNA-based therapeutics to ensure the safety and efficacy of these therapeutics for patients
  • Investigating the available different approaches to show bioactivity in cell culture to ensure safety for patients

12:00 pm Multi-Valent mRNA Vaccines: Strategies for Effective Design & Potency Assessment

  • James Shu Vice President - Analytical Science, Abogen Biosciences


  • Investigate the complexities of developing multi-valent mRNA vaccines to combat various infectious diseases
  • What are quantitative potency assays for multi-valent vaccines and their challenges posed by variant-specific antibodies
  • What are the potential engineering approaches to simplify potency assessments for multi-valent mRNA vaccines

12:30 pm Life-cycle Approach of Cell-Based Assays to Support Drug Development of RNA Therapeutics


  • 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


  • 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 Innovating & Digitalising mRNA Vaccine & Therapeutics Production Platform Processes

  • Zoltán Kis Senior Lecturer (Associate Professor), University of Sheffield


  • What is the importance of innovation and digitalization in production processes
  • How to ensure data integrity, security, and compliance in digitalized processes
  • What are the future prospects and emerging trends in digitalizing mRNA vaccine and therapeutics manufacturing

3:00 pm Unveiling the Next Generation of mRNA Analytical Development to Revolutionize the Current Analytical Toolbox

  • Iulia Oita Chemistry, Manufacturing & Controls Manager, Ziphius Vaccines NV


  • 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

3:30 pm End of the 2nd mRNA Analytical Development Summit Europe 2024