7:30 am Registration Opens & Light Welcome Breakfast

8:25 am Chair’s Opening Remarks

  • Jianmei Kochling Senior Director, Analytical Development CMC, MRNA Center Of Excellence, Vaccine Research & Development, Sanofi

Unlocking the Future: Diving into the Cutting-Edge World of mRNA Analytical Development to Ensure Development of Highly Efficacious mRNA Medicines

8:30 am Exploring the Main Milestones Achieved in mRNA Analytical Development & How to Overcome the Challenges You Encounter


  • Understanding the best-in-class analytical approaches available 
  • Highlighting the pivotal role of mRNA analytical techniques in the development of mRNA-based vaccines
  • Addressing the challenges faced in mRNA analysis, such as RNA stability, contamination, and data complexity

9:00 am Panel Discussion: Unveiling the Next Generation of mRNA Analytical Development


  • Discussing the latest advances in analytical tools and novel approaches towards analyzing and quantifying mRNA medicines
  • 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 mRNA analytics
  • Learning from diverse platforms to address shared hurdles and enhance analytical strategies
  • How the current techniques can be generated from covid vaccines into cancer vaccines

9:45 am Multimodal Support of mRNA therapeutic Development

  • Wayne Doyle Senior Bioinformatics Scientist, Eclipsebio


  • Use RNA structure to evaluate stability, lot variations, and LNP encapsulation
  • Evaluate the mRNA therapeutic life cycle with ribosome profiling
  • Locate and quantify dsRNA contaminants with next-generation sequencing

10:00 am Morning Break & Speed Networking


This session is your opportunity to get face-to-face time with many of the brightest minds working in the mRNA analytical development field, and establish meaningful business relationships to pursue for the rest of the conference

Ensuring Raw & Starting Material Quality for Advanced mRNA Analytical Development Ensuring Streamlined mRNA Drug Discovery & Development

11:00 am Ensuring Excellence: Quality Control of Raw & Starting Materials for mRNA-Based Therapeutics

  • John Haserick Vice President Of Platform Development, Innovac Therapeutics


  • What specific attributes of mRNA raw materials are evaluated during quality control processes, and how do these attributes influence the safety and efficacy of the final product? 
  • What are the established regulatory guidelines for quality control of mRNA raw materials? 
  • What strategies are being explored to address challenges related to batch-to-batch variability and quality assurance? 

11:30 am Revealing the Latest Advantages in Using Synthetic mRNA for Your mRNA Therapeutic

  • Dinesh Dhamecha Pharmaceutical Formulation Scientist, Elastrin Therapeutics


  • How does the origin of mRNA impact the overall quality, purity, and reproducibility of mRNA synthesis? 
  • What are the structural differences of using synthetic mRNA?

12:00 pm mRNA Sequence Mapping via IP-RP Liquid Chromatography Coupled with Tandem Mass Spectrometry


  • mRNA digestion workflow 
  • LCMS methodology 
  • Bioinformatics Analysis

12:30 pm Reviewing Current Existing Approaches for mRNA Analytical Development

  • Yimin Hua Head of Biochemistry Analytical Development, Sanofi


  • Investigating the advantages of using capillary electrophoresis over current methods to get high sensitivity and the ability to analyze samples with low volumes
  • Discussing the development of new analytical methods for the characterization of interactions between antigens and adjuvants in vaccines by capillary electrophoresis
  • Reviewing what is in store for the future of capillary electrophoresis and its potential for speeding up analytical methods

1:00 pm Lunch Break & Networking

Development of Functionally Relevant Potency Assays & mRNA Covalent Adducts to Achieve Enhanced Precision of Your mRNA Products

2:00 pm Understanding the Process of Formation of mRNA Covalent Adducts & Influencing Factors


  • Identifying the accelerating factors for covalent adduct formation 
  • Creating stress samples in a methodical approach to support the development of a stability-indicating RP-IP method 

2:30 pm Developing Different Types of Potency Assays to Measure Contaminants & Bioreactivity of mRNA-Based Therapeutics

  • Andrew Geall Chief Development Officer, Replicate Bioscience


  • Investigating the development of novel purity assays to improve the efficacy of mRNA-based 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

3:15 pm A Comprehensive Analysis of the mRNA-Lipid Nanoparticle (mRNA-LNP) by Capillary Electrophoresis (CE) & LC-MS


  • Calculate mRNA-LNP encapsulation efficiency with determination of purity and size of both encapsulated and unencapsulated mRNA
  • Assess poly(A) tail length and profile characterization with single-nucleotide resolution
  • Identify impurities in ionizable lipids with in-depth structural characterization

3:45 pm Considerations for mRNA Potency Assay Development for Gene Editing Products


  • Overview of matrix approach for potency assay development
  • Review of available regulatory guidance and expectations for phased-based approach to potency assay development 
  • Tools and considerations when measuring biological cascade of mRNA delivery in vitro 
  • Challenges associated with potency assay development for gene editing products 

4:15 pm Afternoon Break & Scientific Poster Session


By joining our dedicated session, you will have the opportunity to engage in meaningful discussions with your peers about ongoing work in the field of mRNA therapeutics. As the discovery and development of these therapies continues to advance, it is essential to collaborate and share knowledge to streamline the approval process. Share your latest findings and gain insight into the cutting edge work of your peers. The goal of this session is to foster a sense of community and promote collaboration within the field.

Improving Translational Processes: Exploring Novel In Vitro & Biophysical Approaches for Improved Characterization of mRNA Drug Products

4:45 pm Next-Gen Cryo-EM Based LNP Characterization: Quantitatively Determine Size, Shape & Particle, Morphology at Scale

  • Karl Bertram Cryo-EM Scientist, Managing Director, ATEM Structural Discovery


  • FDA and other regulatory authorities demand the characterization of morphologic critical quality attributes (CQAs) in LNP formulations
  • Imaging based methods like cryo-EM are ideal to determine nanoparticle morphology – but typically only of qualitative nature and limited in throughput
  • We now overcome these limitations on our AI-powered LNP analysis platform. For the first time offering high-throughput sample processing and statistically reliable numerical results for multiple LNP CQAs in one single assay

4:55 pm Identifying novel LNPs by Combining High Throughput Screening & Single Cell Multiomic Readouts


  • Importance of identifying novel LNPs for improving drug delivery efficiency and efficacy
  • The advantages of combining HTS and single cell multiomic readouts in elucidating LNP-cell interactions
  • Potential applications and future directions for the integration of these technologies in drug delivery research

5:25 pm Enhancing Protein Translation Efficiency: The Impact of Nucleotide Modifications


• 6-Methyladenosine modification in tRNA improves codon-anticodon interactions, leading to more accurate and efficient translation

• 2’-O-Methylation of tRNA enhances its stability, ensuring a steady supply of properly modified tRNA for translation processes

• Understanding the influence of these nucleotide modifications can lead to insights into disease mechanisms and potential therapeutic targets

5:55 pm Chair’s Closing Remarks

  • Jianmei Kochling Senior Director, Analytical Development CMC, MRNA Center Of Excellence, Vaccine Research & Development, Sanofi

6:00 pm End of Conference Day One