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Event objectives
mRNA technology has revolutionized medical innovation, offering broad potential applications across fields such as oncology, rare genetic disorders, and personalized medicine. In addition to conventional mRNA-based approaches, advancements in self-amplifying mRNA (saRNA) and circular RNA (circRNA) are driving the next generation of therapeutic solutions. Ensuring the quality of these therapies requires rigorous control of impurities, including truncated RNA species, double-stranded RNA (dsRNA), and residual manufacturing components (e.g., enzymes, lipids, or nucleotides), as these can impact safety and efficacy. Additionally, the development of innovative delivery platforms, such as targeted lipid nanoparticle (LNP) formulations, is advancing into clinical trials. While these novel solutions enhance efficacy, stability, and versatility, they also introduce complex analytical challenges that must be addressed.
Developers face the complexity of designing and manufacturing these biomolecules, along with their delivery systems, while ensuring product quality and regulatory compliance. Critical factors include optimizing translation efficiency, preserving molecular stability, and mitigating potential immunogenicity. As a result, analytical methods are advancing to offer more robust and efficient solutions. The unique structures and mechanisms of action associated with saRNA and circRNA further compound these challenges, necessitating the development of highly sophisticated analytical approaches.
To address these challenges, USP Biologics will convene a virtual summit to foster collaboration among stakeholders, including industry experts, regulatory bodies, and researchers. This event will focus on addressing key hurdles, sharing innovations in analytical technologies, and developing strategies to advance standards for next generation of therapeutics. Through these collaborative efforts, USP Biologics seeks to support the safe, effective, and widespread application of cutting-edge RNA-based therapies across diverse medical fields.
USP is currently seeking speakers who would like to share their work in this Summit and participate in an open dialog session. Potential speakers should visit our Call for Abstracts page for further information.
The mRNA Virtual Summit will be of interest to:
- Suppliers and manufacturers of mRNA vaccines and therapeutics
- Analytical development scientists and managers involved in mRNA technology, including mRNA delivery
- Contract manufacturers for mRNA technology
- mRNA testing organizations and control labs
- Regulatory agencies
- Afrigen’s Experience of Analytical challenges in mRNA vaccines
- Comprehensive mRNA Characterization by LC-MS-MS using RNase 4
- Direct Sequence Mapping and Characterization of mRNA Using Mass Spectrometry
- Harnessing Platform Methods for mRNA Quality Control
- Superior Quality Control for Next Generation mRNA Therapeutics
Day 2 presentations
- An evaluation of key analytical method
- Analytical case studies of mRNA-based vaccine and therapeutics by capillary electrophoresis (CE)
- Analytical insights in characterization of poly(A) tail by complementary techniques
- Analytical Strategies for dsRNA Detection in IVT mRNA
- Comprehensive characterization of multivalent mRNA vaccines functionality
- Development of a novel luminescent assay for sensitive and specific quantitation of double-stranded RNA
- mRNA Therapeutics - Last Chance for Platform Methods
- Probing RNA Base Pairing and Ligand Interactions