mRNA Therapeutics 

Supporting the Development of mRNA Therapeutics

Characterization of mRNAs

Identity confirmation by mRNA fingerprinting

  • Information on poly(A) tail length and dispersity

Capping efficacy by HPLC/MS

  • CAP structure (e.g. CAP-0 vs. CAP-1)
  • Analysis of mRNA purity/integrity
  • HPLC, CGE and Tape Station
  • Determination of molar absorption coefficient
  • Thermodynamic analysis by UV or DSC
  • Base composition analysis

Characterization of mRNA drug product

  • Analysis of size and mRNA encapsulation in formulations (DLS and Ribogreen)
  • Analysis of lipid composition

mRNA and mRNA-LNP bioanalysis

  • PK and biodistribution of mRNA (GXP)
  • PK and biodistribution of cationic lipids

mRNA pharmacology

  • Proof-of-concept studies
  • Safety analyses
  • Cell-based assays to study mRNA Tx
  • Target expression/function (ELISA, Luminex and MSD platforms, cell viability, flow cytometry)
  • Ligand-receptor interaction and uptake studies / histology