Workshop B: Overcoming Challenges for Development of Multivalent mRNA Products
Time: 10:30 am
day: Pre Conference Workshop Day
Details:
Multivalent mRNA-based vaccines have entered clinical development, offering the possibility of one-shot prophylaxis against multiple pathogens or multiple variants of the same parent pathogen. Similar considerations of multivalency or cocktail approaches may apply to mRNA therapeutics as well. However, at present, there is uncertainty surrounding process development, analytical characterization, formulation and lot release strategies for multivalent mRNA drug products (DP). An apparently uncomplicated approach of individually formulating (for example, encapsulating in lipid nanoparticles) each mRNA construct and then combining these formulations to form the final DP. This may have been the approach taken for approved bivalent Covid-19 vaccines and the candidate combination vaccines that are entering clinical trials. Even in these cases, testing individual components for release assays such as dose and potency in the combination DP can be challenging due to non-specificity of some of the conventional test methods. This workshop will facilitate discussions aimed at better understanding and addressing these challenges, and ultimately accelerating development of multivalent mRNA DPs.
- Multivalent mRNA vaccines can offer protection against variant serotypes of the same parent pathogen or multiple diverse pathogens
- Process development, analytical characterization and lot release of multivalent mRNA drug products remain challenging especially when variants are closely related, such as SARS-CoV-2 variants
- In the absence of selective and specific antibodies against each encoded antigen, alternatives to immunoassays need to be developed for multivalent DPs to determine potency, content and functional stability of individual antigens in multivalent drug products
- Opportunities for integrating process analytical technologies into development of mRNA drug substance and formulated drug product manufacturing will be explored
