Newsletter | July 17, 2023

07.17.23 -- De-Risk Your mRNA Development

Establishing Analytical Methods For mRNA-Based Therapies

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.

Determining RNA Integrity And Purity By Capillary Gel Electrophoresis

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.

Lipid Nanoparticle Compositional Analysis By UHPLC-CAD

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.

Who Counts As An Expert? Establishing Analytical Methods For Emerging mRNA-Based Therapies

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.

Key Benefits Of PCR-Based mRNA Manufacturing For Clinical Development

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.

Analytical Development And Characterization For mRNA Vaccines And Therapeutics

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 critical quality attributes (CQAs). 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.