The emergence of mRNA as a therapeutic modality has caused a transformative shift in the biopharmaceutical industry. To fully realize the potential of mRNA as a therapeutic or vaccine modality, biopharma developers will need to employ cutting-edge analytical methods to ensure the safety and efficacy of these novel products.
A comprehensive set of analytical tests are required to ensure the quality and safety of nucleic acid-based modalities. Here, we provide a detailed description of assays for sequence identification and lipid nanoparticle (LNP) composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
To ensure the quality of mRNA products, it is important to confirm the integrity of the RNA in terms of its size and length. Capillary gel electrophoresis (CGE) is commonly employed for the analysis of RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.
Ultra-high performance liquid chromatography (UHPLC) coupled with charged aerosol detection (CAD) is a powerful technique for the analysis of compounds, such as lipids, that do not contain chromophores. Explore results generated from an internal study using UHPLC-CAD and a proprietary mRNA-LNP formulation.
Gain insight into how you can de-risk mRNA regulatory approvals with critical quality attribute (CQA) characterization and lot release testing supported by a partner that offers three testing packages for mRNA starting materials, drug substances, and drug products and has more than 50 assays to confirm CQAs and 20 enabling technologies.
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