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40 Pharmaceutical Technology ® The Real Message Behind Commercial mRNA Products April eBook 2023 PharmTech.com XYZ+ - STOCK.ADOBE.COM The Role of Separation Techniques in the Analysis of mRNA Therapeutic Drug Substances and Drug Products Christina Vanhinsbergh, New Modalities Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK. 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 separationmethods are commonly used for cha rac ter i zat ion a nd qua nt i f icat ion of t he d r ug substance and drug product. M essenger ribonucleic acids (mRNAs) are large single‑stranded polynucleotides present within the cells of the body. mRNA naturally plays a role in the synthesis of proteins by carrying genetic code from the nucleus to the cytoplasm where it is translated into a protein by ribosomes. mRNA can also be used as a modulator of protein production processes to treat diseases in an approach known as RNA therapy. Modulation of protein production can be in the form of producing pathogen‑associated antigens that stimulate the immune system (mRNA vaccination) or in the production of proteins that are otherwise lacking due to disease. There are Abstract