With more than 10 years of expertise and the development of over 150 specific analysis methods in the field of mRNA analysis, Axolabs has an extensive portfolio for the characterization of mRNA therapeutics and mRNA vaccines. Axolabs offers its customers an almost complete package of analytical methods from the determination of critical quality attributes of mRNA drug substance and drug product, including mRNA-LNP bioanalysis, to the study of mRNA pharmacology. 

Characterization of mRNA therapeutics and mRNA vaccines 

• Characterization of mRNA drug substance
  • Identity sequence confirmation by mRNA fingerprinting with uHPLC-MS analysis
  • Residual plasmid detection and quantification by qPCR 
  • Residual protein detection via SDS-PAGE and silver staining 
  • Detection of dsRNA with Dot blot analysis and ELISA 
  • Determination of poly(A) tail length and polydispersity by uHPLC-LC/MS  
  • Poly-A tail determination and synthetic mRNA sequence validation by Oxford Nanopore Sequencing 
  • Characterization of the 5'terminus including the cap-structure ( capped, uncapped, capping efficiency) by uHPLC-MS
  • Analysis of mRNA purity, integrity and length by Size Exclusion Chromatography (SEC) and IP-RP-uHPLC 
  • Qualification/Validation of selected mRNA methods under GMP standards 
  • Analysis of protein expression

• Characterization of mRNA drug product
  • Analysis of size, polydispersity and zeta potential by DLS
  • mRNA encapsulation in formulations by Ribogreen®   
  • Analysis of lipid composition in LNP formulations  
  • Performance of all characterization tests as for drug substances 
     
• mRNA and mRNA-LNP bioanalytics
  • Determination of PK and biodistribution of mRNA (GLP/GCP)
  • Determination of PK and biodistribution of cationic lipids 
     
• mRNA pharmacology
  • Proof-of-concept studies
  • Safety analyses
  • Use of cell-based assays to study mRNA therapeutics
  • Determination of target expression/function (ELISA, Luminex and MSD platforms, cell viability, flow cytometry)
  • Ligand-receptor interaction and uptake studies / histology 
    (for details see poster)