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 is organizing this virtual Open Forum to communicate and collaborate with stakeholders, subject matter experts, regulators, and others involved in this pharmaceutical modality.
The Biologics Open Forum will be of interest to 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