Functionality and translation fidelity characterization of mRNA vaccines using platform based mass spectrometry detection.

The success of mRNA-based therapeutics and vaccines is attributed to their rapid development, adaptability, and scalable production. Modified ribonucleotides like N-methylpseudouridine enhance stability and reduce immunogenicity but were recently found to induce cellular immunity to off-target, +1 ribosomal frameshifted protein. We developed a new platform using cell-free translation (CFT) and liquid chromatography-tandem mass spectrometry (MS) to detect, characterize, and quantify antigen proteins from mRNA constructs.

Development of a Cell-Based Reporter Potency Assay for Live Virus Vaccines.

The rapid development of potency assays is critical in the development of life-saving vaccines. The traditional plaque assay or fifty percent tissue culture infectious dose (TCID) assay used to measure the potency of live virus vaccines is time consuming, labor intensive, low throughput and with high variability. Described here is the development and qualification of a cell-based reporter potency assay for two vaccines for respiratory viral infection, one based on the recombinant vesicular stomatitis virus (rVSV) backbone, termed Vaccine 1 in this paper, and the other based on the measles virus vector, termed Vaccine 2.

Adaptation of an rVSV Ebola vaccine purification process for rapid development of a viral vaccine candidate for SARS-CoV-2.

During the COVID-19 pandemic, long development timelines typically associated with vaccines were challenged. The urgent need for a vaccine provided a strong driver to reevaluate existing vaccine development approaches. Innovative approaches to regulatory approval were realized, including the use of platform-based technology.