Significant investment is being made in developing mRNA-based vaccines for infectious diseases such as Influenza and RSV with an expectation of speedy development with high efficacy. There are, however, several CMC pre-requisites to enable these expectations.
- Standardize mRNA and LNP design platforms to maximize therapeutic index while ensure manufacturability.
- Continuously build product understanding through analytical and biological characterization in pre-clinical and clinical settings.
- Establish phase appropriate control strategy that incorporates latest product understanding and regulatory expectations.
- Develop and standardize designs of manufacturing process and formulations that meets control strategy while retains flexibility to capture innovation in product and process platforms.
- Establish end to end manufacturing & QC footprints for clinical and commercial launch of a dynamic product portfolio; This network should include external sourcing and/or internal manufacturing of special raw materials at appropriate levels of quality, scale, and cost.
This presentation will summarize status of CMC platforms and describe specific elements of mRNA-LNP to consider in designing control strategy, manufacturing process, thermostable formulation, and associated technologies. Additionally, the requirement to build a deep understanding of critical materials will be emphasized. The enabling role of data continuum infrastructure and data science tools to efficiently optimize processes will be noted.