Analytical Development and Characterization for mRNA Vaccines and Therapeutics

With proven efficacy as vaccines for SARS-CoV-2, mRNA has revealed its versatility and the fast-to-market potential. mRNA may go beyond prophylactic vaccines and has a promising future as therapeutic vaccines for cancer and as therapeutics across multiple disease areas.

Given the unique characteristics of the mRNA/LNP complex, new expertise and a series of novel analytical capabilities are required to ensure fast, efficacious, and compliant mRNA drug products.

Our assay packages and phase appropriate assay development and validation capabilities provide the product and process knowledge you need to develop a Quality Target Product Profile (QTPP) and identify the Critical Quality Attributes (CQAs) to unchain the disruptive potential of your mRNA therapy.

You will benefit from a quantitative, comprehensive understanding of your mRNA assets to de-risk regulatory approvals through our best-in-class testing services, a leading bioinformatics platform, and robust regulatory and technical expertise. 

ASSAYS THAT DE-RISK mRNA DEVELOPMENT AND MANUFACTURING

To help you de-risk and expedite the product and process development of your mRNA vaccine or therapy, we offer a broad selection of assay packages for various stages of development and process control points. In addition, our capabilities in analytical development and stability testing services enable us as a partner in your journey of product and process development. 

Plasmid DNA Analytical Testing – Template for mRNA Transcription

• Sequence verification by NGS
• Concentration and purity by UV spectrophotometry
• Purity via homogeneity of plasmid using CE-LIF
• Residual E. coil protein by BCA or ELISA
• Residual E. coli DNA by qPCR
• Residual E. coli RNA by qPCR
• Compendials (e.g., sterility, endotoxin, pH, appearance, etc.)

Drug Substance – mRNA Molecule Analytical Testing

• RNA content by absorbance
• mRNA sequence identity confirmation by NGS
• Capping efficiency by RP-LC/MS
• Poly A tail characteristics by RP-LC/MS or CE
• mRNA purity by HPLC
• Contaminating dsRNA impurities by ELISA
• Cell-based potency assays
• Residual plasmid DNA template by qPCR
• Residual enzymes & proteins
• Compendials (e.g., sterility, endotoxin, pH, appearance, etc.)

Drug Product - mRNA Encapsulated in LNP or Liposome Analytical Testing

• RNA identity by NGS
• Lipid identity by RP-HPLC-CAD
• LNP size/polydispersity by DLS
• RNA size and integrity by CGE
• LNP zetapotential
• Intact cargo by HPLC
• Lipid content by RP-HPLC-CAD
• Encapsulation efficiency by fluorescence or enzyme digestion
• In vitro / cell-based functional and potency assays
• Residual ethanol by GC
• Compendials (e.g., sterility, endotoxin, pH, appearance, etc.)

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Related Resources

• Application Note: Establishing Analytical Methods for mRNA-based Therapies

  Provides a detailed description of assays for sequence identification and LNP composition, two critical quality attributes of mRNA-LNP products.

• Technical Note: Determining RNA Integrity and Purity by Capillary Gel Electrophoresis

  Learn why Capillary Gel Electrophoresis is a suitable method for the assessment of mRNA integrity and purity.

• Technical Note: Lipid Nanoparticle Compositional Analysis by UHPLC-CAD

  Discover how UHPLC-CAD can be used to confirm the identity, quantity, and purity of lipids, ensuring the quality of mRNA-LNP drug products.

• Webinar: Who Counts as an Expert? Establishing Analytical Methods for Emerging mRNA-based Therapies

  In this webinar, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substance and drug product.