Conference Day 2

8:50 am
Chair’s Opening Remarks

  • Harkewal Singh Director, Head of Bioanalytics – Nonclinical Sciences, Moderna

Leveraging Assays to Better Investigate Protein Expression & Function for Improved Therapeutic Effect

9:00 am Assay Development for Monitoring mRNA Functionality


  • Overview of methods used to confirm that the target protein is functional.
  • Exploring the relationship between mRNA integrity and functionality.
  • Cell-based potency assay development for both DS and DP samples – case studie

9:30 am LC-MS Based Assay Development for Absolute Quantification of Protein Expression from mRNA Vaccine Candidates

  • Kristen Randall Associate Director of Bioanalytical/DMPK , mRNA Center of Excellence, Sanofi


  • Overview of assays used for measuring protein expression from mRNA vaccines
  • A robust and sensitive assay for mRNA expression using targeted proteomics
  • Case study of determining mRNA expression from mRNA vaccines

10:00 am
Morning Networking Break

Assessing Bioanalytical Tools to Evaluate the Purity of mRNA Drug Substances for Reduced Immunogenic Side Effects

11:00 am Evaluate mRNA Immunogenicity Using Macrophage/Monocyte Cell Lines with CRISPR-Mediated Gene Knockout

  • Li Li Assistant Professor, University of Massachusetts Chan Medical School


  • Immune cells provide a more sensitive readout of immunogenic side products in mRNA preps than non-immune cells
  • CRISPR knockout of key innate immune sensors in immune cell lines
  • Detect source of contaminants and their immune sensing pathways using such immune cell lines

11:30 am Roundtable: Reviewing Assays to Determine the Presence of dsRNA & Reduce Undesired Immunogenicity

  • Corey Perez Principal Scientist - Discovery, Senda Biosciences


  • Which methods are currently used by the field to measure the presence of dsRNA?
  • What types of controls and standards are being used in these assays to facilitate accurate and reliable quantitation?
  • What approaches are being employed by the field to translate in vitro to in vivo response? Which biomarkers are most useful?
  • What novel/next-generation methods are being developed to address existing challenges?
  • What characteristics would define an ideal assay to measure immunogenicity?
  • How is the field approaching the definition of impurity limits? Does this approach differ based on therapeutic area?

12:30 pm
Networking Lunch Break

Evaluating In Vitro Tools to Accurately Assess mRNA Drug Products for Improved Quality & Activity

1:30 pm Development of HPLC-CAD to Characterize Lipids in mRNA Related Drug Research & Delivery

  • Dongliang Ruan Scientist of Analytical Chemistry, Providence Therapeutics


  • How to develop analytical method for characterizing lipids used in LNP mRNA Drug Research
  • Lipid analysis utilizing HPLC-CAD
  • Bio-analytical methods optimized for analysis of lipid delivery platforms

2:00 pm Microphysiological Systems for the Assessment of Activity of mRNA Therapeutics

  • Ryan Sowell Director - Translational Biology, Strand Therapeutics Inc.


  • Overview of the current state of microphysiological systems (MPS)
  • Opportunities for the use of MPS in drug development
  • Challenges with the use of MPS in mRNA therapeutics

Optimize Manufacturing with Robust & Reproducible Assays to Enable Successful Scale-Up

2:30 pm Quantitatively Distinguishing Full (Correct) Length mRNA From Truncated or (Self-)Extended mRNAs

  • Craig Martin Professor, University of Massachusetts Amherst


  • Degradation, truncation, and self-primed extension occur during manufacturing
  • Evaluation of these behaviors is critical to optimizing manufacturing approaches conditions
  • New approach allows relatively easy assays

3:00 pm Chairs Closing Remarks

  • Harkewal Singh Director, Head of Bioanalytics – Nonclinical Sciences, Moderna

3:15 pm
End of mRNA Assay Development Summit 2023