mRNA-Based Product Design, Formulation, and Preclinical Evaluation

1 Course Unit

This course introduces the scientific and engineering principles underlying mRNA vaccines and therapeutics, emphasizing product- focused design and preclinical evaluation. Students learn the molecular biology, biochemistry, immunology, pharmacology, and formulation science required to design mRNA-based products within an industry- relevant framework. Topics include mRNA lifecycle and structural elements, codon optimization, nucleotide modification, lipid nanoparticle (LNP) formulation, critical quality attributes (CQAs), analytical characterization, and in vitro potency and reactogenicity testing. The course culminates in the design of an mRNA construct using a web- based portal, submission for manufacturing, and laboratory-based testing of the manufactured product. Students prepare a comprehensive Target Product Profile (TPP) and final technical report integrating design rationale, quality attributes, experimental results, and preclinical performance. Fall 1 Course Unit