Conference Day One

Wednesday 30th August 2023

8:00 am
Registration Opens & Morning Coffee

8:50 am Chair’s Opening Remarks

Achieving More Efficient & Precise mRNA Analysis with HPLC & LCMS Techniques

9:00 am Highlighting the Development of High-Performance Liquid Chromatography that has Led to the Development of More Efficient & Precise Methods for the Analysis of mRNA

Synopsis

  • To Be Announced

9:30 am Development & Application of Liquid Chromatography-Mass Spectrometry (LC-MS) Methods for the Characterisation of mRNA Drug Substance

Synopsis

  • A comprehensive overview of the liquid chromatography mass spectrometry methods that can be used to characterise mRNA drug substance
  • Revealing the potential applications of LC-MS in quality control to allow industries using this technology to ensure the safety and quality of their products
  • Delving into the difficulties with the data analysis of LCMS and how to speed this method up to ensure accurate and reliable results
  • Future opportunities for LC-MS analysis of mRNA drug substance

10:00 am Exploring Moderna’s Newest Advancements in mRNA Therapeutics Beyond mRNA Vaccines

Synopsis

  • How modifications of mRNA, such as its structure, chemistry and stability, can impact the overall function of the mRNA in the context of therapeutic applications
  • Addressing the immune tolerance of mRNA as a therapeutic to ensure that the mRNA is not rejected by the immune system
  • How the development of LNP adaptation is being used to improve immunity and targeted delivery of mRNA therapies
  • Reviewing mRNA in the clinic for rare genetic disorders with preclinical and clinical data

10:30 am Morning Break & Speed Networking

Synopsis

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

Taking a Closer Look into the Different Techniques Used for Accurate mRNA Characterisation

11:30 am Highlighting the Similarities & Differences in the Testing Strategies Based on the CQAs of DNA vs mRNA

  • Roland Pach Global Expert Cell & Gene Therapy Analytics CMC, Roche

Synopsis

  • Understanding the importance of considering the regulatory framework in place when selecting appropriate methods for testing DNA and mRNA
  • Reviewing the latest regulations and guidelines for DNA and mRNA to ensure that the testing methods used are compliant
  • Exploring the unique characteristics of each molecule to understand what method is preferred for testing the mRNA and DNA
  • Discussing analytical development strategies for the corresponding methods

12:00 pm The Whole is Greater Than a Sum of it’s Parts: mRNA as API & as a Part of LNP Structure

Synopsis

  • Challenges with understanding of structure-property-function relationship required for informed design and development of mRNA delivery vectors.
  • What can we learn from biophysical techniques?
  • Opportunities with benchtop biophysical approaches to evaluation of higher order structure and thermal stability of mRNA and mRNA-LNPs

12:30 pm Maximising Your mRNA Characterisation to Ensure Safety, Efficacy & Quality of mRNA Therapeutics

  • Stefan Heinz Director - Analytical Development, Curevac GmbH

Synopsis

  • Reviewing the instrumentation breakthroughs that have advanced mRNA characterisation, allowing for more accurate analysis and overcoming issues related to sensitisation
  • Exploring nuclear pore characterisation and how you can control the difference in formulation and heterogeneity of your nanoparticles once administered in the body
  • Exploring the latest advances in secondary structure characterisation and how this can optimise its efficacy and safety

1:00 pm
Networking Lunch

Exploring New Purification Strategies to Improve the Quality of mRNA Drugs

2:00 pm Roundtable Discussion:Addressing the Technical & Regulatory Challenges Associate with dsRNA

Synopsis

  • Understanding dsRNA ability to effectively target specific mRNA sequences, resulting in increased specificity and accuracy in mRNA analysis
  • Discussing the possible strategies to improve its specificity and reduce the potential for off-target effects
  • Addressing the regulatory hurdles in the use of dsRNA in mRNA analytical development to ensure the safety and efficacy of these technologies

3:00 pm Afternoon Break & Poster Session

Synopsis

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 continue 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.

Development of Functionally Relevant Potency Assays to Achieve Enhanced Precision of Your mRNA Vaccines

4:00 pm Understanding Which Potency Challenges Arise with mRNA Vaccines & How to Overcome them to Ensure a Safe & Efficient mRNA Vaccine

  • Jens Schumacher Senior Director - Formulation Analytic & Assay Development, BioNTech AG

Synopsis

  • Discussing the existing challenges with potency measurements for mRNA vaccines
  • Exploring the approaches used for analysing potency in mRNA vaccines

4:30 pm Utilizing eRibo to Interrogate Ribosome-RNA Associations

  • Peter Chu Cheif Executive Officer, Eclipsebio

Synopsis

  • Using sequencing technology to leverage a multidimensional view of transcripts from cap to tail
  • How ribosome profiling technology can be used to gain insight into the translation status of a single transcript and the transcriptome 

4:40 pm The Challenges of the Analytical Control Strategy for Seasonal Multivalent mRNA Vaccines

  • Davide Pacitti Associate Director - Cellular Analytics Platform, GlaxoSmithKline Plc

Synopsis

  • Discussing potency methods: constraints for the development of potency methods, in the specific case of (multivalent) mRNA vaccines
  • Exploring critical reagents: potential strategies for the definition and usage of cross-industry-regulators reference standards for mRNA vaccines
  • Uncovering commercial readiness: how to design control strategies for an efficient and seamless commercial release of mRNA vaccines

5:10 pm Approaches in Analytical Methods & Control Strategy During mRNA Vaccine Development & Life Cycle management

  • Stéphanie Prizzon Global Head of Analytical Sciences, mRNA Center of Excellence, Sanofi

Synopsis

  • Phase appropriate approach for developing analytical methods in support of mRNA vaccine development
  • Opportunities in leveraging analytical platform approach
  • Challenges to manage life cycle management and comparability

5:40 pm End of Conference Day One