Christina Vanhinsbergh is New Modalities Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.

Christina Vanhinsbergh

Messenger ribonucleic acids (mRNA) therapeutics are becoming more widespread pharmaceutical tools to treat a wide range of diseases or infections, as highlighted by regulatory approval of two vaccines for SARS‑CoV-2. Alongside their use as vaccines, they also play a role in protein replacement therapy to ensure therapeutic protein is synthesized within the patient. Structural elements, such as the 5’ cap, UTR regions, reading frame, and poly A tail are considered as critical quality attributes (CQAs) that are subject to a range of analytical techniques. However, chromatography and other separation methods are commonly used for characterization and quantification of the drug substance and drug product.

The Real Message Behind Commercial mRNA Products

The Role of Separation Techniques in the Analysis of mRNA Therapeutic Drug Substances and Drug Products

Pharmaceutical Technology’s The Real Message Behind Commercial mRNA Products eBook

This article was previously published in 


eBook: The Real Message Behind Commercial mRNA Products
April 2023
Pages: 40–49

When referring to this article, please cite it as Vanhinsbergh, C. The Role of Separation Techniques in the Analysis of mRNA Therapeutic Drug Substances and Drug Products. 

Pharmaceutical Technology's The Real Message Behind Commercial mRNA Products

Articles

This article reviews a range of techniques available for separative analysis of mRNA therapeutics, their associated impurities, and delivery vehicles.