This article reviews a range of techniques available for separative analysis of mRNA therapeutics, their associated impurities, and delivery vehicles.
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.
Read this article in Pharmaceutical Technology’s The Real Message Behind Commercial mRNA Products eBook
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.
Pharmaceutical Technology
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 eBook (April 2023).
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Exosomes Field Advances with Milestones Achieved by EXO Biologics and ExoXpert
December 4th 2024EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.