Course Description:
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.
The Biologics Open Forum was attended by the following types of stakeholders:
- 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
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
- Vaxarr