8:00 am Coffee & Light Breakfast

8:40 am Chair’s Opening Remarks

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

Delivering on the Regulatory Expectations for Successful mRNA-Based Therapeutics & Breakthroughs Modifying Protein Structures

8:45 am Panel Discussion: Reviewing Standards & Regulatory Requirements of the Analytical Field of mRNA-Based Therapeutics

  • Andrew Geall Chief Development Officer, Replicate Bioscience
  • Chris Broomell Director, Drug Product Analytical Development, Omega Therapeutics


  • Delving into how to give evidence of a state of control and maintain regulatory compliance for your mRNA analytical techniques
  • Revealing how to integrate the new novel mRNA analytical technologies to align to GMP guidelines
  • Understanding how to standardize your mRNA analytical techniques to align to CQAs and CPIs to allow efficient and rapid approval

9:30 am The mRNA Capping Process & Analysis of Capping Efficiency & Impurities

  • May Guo Chief Commercial Officer, Areterna


  • An overview of the mRNA capping process
  • Novel cap analogs for stronger gene expression
  • LC-MS based methods for capping efficiency and poly-A characterization

10:00 am Highlighting the Advancements in mRNA Poly (A) Tail Characterization to Enhance Efficacy


  • Discussing the latest methods used to characterize the poly (A) tail to provide valuable information about the dynamics of mRNA regulation
  • Uncovering new insights into the mechanisms underlying protein expression of the mRNA to pave the way for more effective treatments for a wide range of diseases

10:30 am Advancing LC-based Analytical Tools & Techniques for mRNA Analysis

  • Joe Fredette Principal Product Marketing Manager - Cell and Gene Therapy, Waters Corporation


  • The benefit of ultra-low adsorption chromatography
  • Tools and techniques for mRNA critical quality attribute (CQA) analysis

10:40 am Morning Break & Networking

Advancing mRNA Analytical Development Through Optimized LNP Formulation & Characterization to Enhance Stability & Delivery Efficacy

11:30 am Session Reserved for InDevR


InDevR|Analytical Technology for Vaccine Characterization

12:00 pm Advanced Characterization Approaches for Quality Control of LNP Formulation


  • What considerations should be taken into account when formulating LNPs for various types of therapeutic payloads, such as mRNA, siRNA, or small molecules?
  • Addressing concerns related to immune response, biodistribution, and targeted delivery 
  • What strategies can be employed to improve the encapsulation of mRNA molecules within LNPs?

12:30 pm Maximizing the Strategies for Enhancing LNP Stability & Payload Loading


  • Innovations in lipid selection and engineering for improved LNP stability
  • Approaches to optimize mRNA loading and release kinetics
  • Exploring the influence of lipid components, ratios, and modifications on LNP stability and mRNA delivery

1:00 pm Advancement in mRNA Therapeutics and Vaccines: Overcoming RNase-Related Challenges through RNase-free Single-Use Assemblies & Non-Thermal Plasma-based Inhibition


  • Pioneering Non-Thermal Plasma inhibition of RNases as a cutting-edge alternative for ensuring RNase-free single-use bioprocess containers and assemblies, when conventional methods like thermal, irradiation and chemical inactivation fail
  • Elevate mRNA development and manufacturing processes by mitigating the risk of RNase contamination
  • Exploring the inhibition of RNase through ionized air targeted at enzymes, showcasing an innovative approach to safeguarding bioprocess integrity

1:10 pm Lunch & Networking

2:00 pm A Tale of Tails: Using the Power of Capillary Electrophoresis for the Analytical Characterization of mRNA


  • Development of a robust CGE workflow for mRNA poly(A) tail characterization achieving single-nucleotide resolution
  • Supports diverse poly(A) tail assessments without optimization required for LC gradient methods
  • QC-friendly method well suited for release testing of mRNA therapeutics and vaccines

2:30 pm mRNA Analytical Development Update from Gennova

  • Swarnendu Kaviraj Associate Director Research & Development, Gennova Biopharmaceuticals


  • Updates on the investigational mRNA analytical development techniques
  • Optimizing mRNA analytical development techniques to bring mRNA therapeutics to patients in need

3:00 pm Afternoon Break & Refreshments

Advancing mRNA Analytical Development Through Optimized LNP Formulation & Characterization to Enhance Stability & Delivery Efficacy

3:30 pm Optimizing Analytical Techniques for LNP Characterization to Avoid Impurities & Uncertainties


  • Exploring the techniques to assess LNP size, charge, encapsulation efficiency, and payload release kinetics
  • Addressing the importance of reliable analytical methods in guiding formulation optimization
  • Discussing how impurities can affect LNP stability, therapeutic delivery, and patient safety

4:00 pm Analysis of Uncapped & 5’ Cap Structures of In Vitro-Transcribed mRNA Using LC-MS & LC-UV Methods

  • Julia Baek Senior Scientist, ReCode Therapeutics, Inc


  • Overview of methods used for the generation of 5’-end fragment of mRNA
  • Optimization of Ribozyme assay to generate 5’-end fragment of mRNA
  • Development and optimization of reversed phase chromatography method for the separation of uncapped and cap structures of mRNA

4:30 pm Novel Stability-Indicating Method for the Simultaneous Determination of RNA & DNA Co-Loaded in a Single LNP

  • Quinner Baltazar Associate Director, Analytical Development, SalioGen Therapeutics


  • Development of a stability-indicating method is crucial for assessing the integrity and quality of RNA and DNA co-loaded in LNPs
  • This novel stability-indicating method provides a valuable tool for researchers and industries working with RNA and DNA-loaded LNPs, ensuring the reliability of their formulations

5:00 pm End of the 3rd Annual mRNA Analytical Development Summit 2024