Course Description: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.
USP Biologics held a virtual mRNA Summit to communicate and collaborate with stakeholders, subject matter experts, regulators, and others involved in this pharmaceutical modality.
Who should participate:
- 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
Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.