07.17.23 -- De-Risk Your mRNA Development

A comprehensive set of analytical tests is required to ensure the quality and safety of nucleic acid-based modalities. Here, we provide a detailed description of assays for sequence identification and LNP composition and two critical quality attributes of 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.

The success of the first vaccines for SARS-CoV-2 demonstrated the effectiveness of mRNA technology. The sudden emergence of this novel modality has necessitated the rapid development of analytical methodologies. Here, we describe the use of cutting-edge technologies to assess critical quality attributes of mRNA drug substances and products.

To unlock the potential of your mRNA therapies and accelerate your mRNA development and manufacturing program, discover the benefits of a novel PCR-based mRNA drug substance manufacturing process. With this innovative and flexible process, mRNA can be provided at all scales and qualities for all stages of an mRNA program life cycle.