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

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.

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About the author

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

Editor’s Note: This article was previously published in LCGC Europe 2023 36 (2) pp. 42–49.

Article details

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

Citation

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 eBook (April 2023).