The rapid design and development of mRNA-based vaccines for the COVID-19 pandemic brought mRNA technology to the forefront of medical innovations with potential applications beyond infectious diseases, including cancer. However, the steady advancement of this technology must be accompanied by corresponding updates to the analytical approaches for ensuring the identity, safety, and efficacy of these therapeutic modalities.
Developers are not only challenged by the complexity of these biomolecules and their delivery vehicles but also by the need to develop flexible methods to accommodate the ongoing changes in the mRNA structures and final formulations. Key elements such as efficiency of translation, molecular stability, and potential immunogenicity all have an impact on their final performance. To further advance these important efforts, USP Biologics held a virtual Open Forum to communicate and collaborate with stakeholders, subject matter experts, regulators, and others involved in this pharmaceutical modality.
Day One Presentations
USP’s Tools to Support Quality and Consistency of mRNA Vaccines, Fouad Atouf and Sarita K. Acharya
Analytical Challenges, Solutions, and Perspectives on the Future Analysis and Characterization of mRNA, Khaled Yamout
The Analytical Challenge of Particle Heterogeneity in the Development of mRNA Vaccines, Frank Zuo
Epidemic Preparedness: Towards Analytical Standardization for Rapid Response Vaccine Delivery, Franz Schnetzinger
Consideration on mRNA Products Potency Testing, Jan Michel Falcke
Day Two Presentations
Uncovering RNA Payload, Empty Particles, and Physicochemical Heterogeneity of Lipid Nanoparticles via A Single Nanoparticle Analyzer, Sixuan Li
Effects of Ionizable and Non-ionizable Excipients on Lyophilized RNA Formulations Using FTIR/ATR Technology, Valentina Paolucci
Advancing Gene Editing Therapeutics: Pivotal Assessment of mRNA Analytics for Phase 1 to Commercialization, Jeffrey Marshall
Light Scattering Solutions for Multi-attribute Quantification of mRNA-lipid Nanoparticle Therapeutics, Martin Kurnik
The Analysis of mRNA Vaccines and Therapies Using RNA Sequencing, Tim Mercer
Vaxarray Platform for Rapid CQA Characterization of Multivalent mRNA Vaccines, Rachel Gao
Subject area:
Biologics
Objectives (If applicable):
N/A
Target Audience (If applicable):
Suppliers and manufacturers of mRNA vaccines and therapeutics
Analytical development scientists and managers involved in mRNA technology including mRNA delivery
Contract manufacturing of mRNA technology
mRNA testing organizations and control labs
Regulatory agencies