Current Analytical Strategies for mRNA-Based Therapeutics
Recent advancements in mRNA technology, utilized in vaccines, immunotherapies, protein replacement therapies, and genome editing, have emerged as promising and increasingly viable treatments. The rapid, potent, and transient properties of mRNA-encoded proteins make them attractive tools for the effe...
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| Format: | Article |
| Language: | English |
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MDPI AG
2025-04-01
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| Series: | Molecules |
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| Online Access: | https://www.mdpi.com/1420-3049/30/7/1629 |
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| author | Julien Camperi Kamalakar Chatla Emily Freund Carolina Galan Steffen Lippold Axel Guilbaud |
| author_facet | Julien Camperi Kamalakar Chatla Emily Freund Carolina Galan Steffen Lippold Axel Guilbaud |
| author_sort | Julien Camperi |
| collection | DOAJ |
| description | Recent advancements in mRNA technology, utilized in vaccines, immunotherapies, protein replacement therapies, and genome editing, have emerged as promising and increasingly viable treatments. The rapid, potent, and transient properties of mRNA-encoded proteins make them attractive tools for the effective treatment of a variety of conditions, ranging from infectious diseases to cancer and single-gene disorders. The capability for rapid and large-scale production of mRNA therapeutics fueled the global response to the COVID-19 pandemic. For effective clinical implementation, it is crucial to deeply characterize and control important mRNA attributes such as purity/integrity, identity, structural quality features, and functionality. This implies the use of powerful and advanced analytical techniques for quality control and characterization of mRNA. Improvements in analytical techniques such as electrophoresis, chromatography, mass spectrometry, sequencing, and functionality assessments have significantly enhanced the quality and detail of information available for product and process characterization, as well as for routine stability and release testing. Here, we review the latest advancements in analytical techniques for the characterization of mRNA-based therapeutics, typically employed by the biopharmaceutical industry for eventual market release. |
| format | Article |
| id | doaj-art-fd74f2f61bc248d1ac615838aa3a2db0 |
| institution | OA Journals |
| issn | 1420-3049 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Molecules |
| spelling | doaj-art-fd74f2f61bc248d1ac615838aa3a2db02025-08-20T02:17:01ZengMDPI AGMolecules1420-30492025-04-01307162910.3390/molecules30071629Current Analytical Strategies for mRNA-Based TherapeuticsJulien Camperi0Kamalakar Chatla1Emily Freund2Carolina Galan3Steffen Lippold4Axel Guilbaud5Cell Therapy Engineering and Development, Genentech, 1 DNA Way, South San Francisco, CA 94080, USACell Therapy Engineering and Development, Genentech, 1 DNA Way, South San Francisco, CA 94080, USADepartment of Molecular Biology, Genentech, 1 DNA Way, South San Francisco, CA 94080, USADepartment of Molecular Biology, Genentech, 1 DNA Way, South San Francisco, CA 94080, USAProtein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, USAProtein Analytical Chemistry, Genentech, 1 DNA Way, South San Francisco, CA 94080, USARecent advancements in mRNA technology, utilized in vaccines, immunotherapies, protein replacement therapies, and genome editing, have emerged as promising and increasingly viable treatments. The rapid, potent, and transient properties of mRNA-encoded proteins make them attractive tools for the effective treatment of a variety of conditions, ranging from infectious diseases to cancer and single-gene disorders. The capability for rapid and large-scale production of mRNA therapeutics fueled the global response to the COVID-19 pandemic. For effective clinical implementation, it is crucial to deeply characterize and control important mRNA attributes such as purity/integrity, identity, structural quality features, and functionality. This implies the use of powerful and advanced analytical techniques for quality control and characterization of mRNA. Improvements in analytical techniques such as electrophoresis, chromatography, mass spectrometry, sequencing, and functionality assessments have significantly enhanced the quality and detail of information available for product and process characterization, as well as for routine stability and release testing. Here, we review the latest advancements in analytical techniques for the characterization of mRNA-based therapeutics, typically employed by the biopharmaceutical industry for eventual market release.https://www.mdpi.com/1420-3049/30/7/1629messenger RNAquality attributeselectrophoresischromatographymass spectrometrysequencing |
| spellingShingle | Julien Camperi Kamalakar Chatla Emily Freund Carolina Galan Steffen Lippold Axel Guilbaud Current Analytical Strategies for mRNA-Based Therapeutics Molecules messenger RNA quality attributes electrophoresis chromatography mass spectrometry sequencing |
| title | Current Analytical Strategies for mRNA-Based Therapeutics |
| title_full | Current Analytical Strategies for mRNA-Based Therapeutics |
| title_fullStr | Current Analytical Strategies for mRNA-Based Therapeutics |
| title_full_unstemmed | Current Analytical Strategies for mRNA-Based Therapeutics |
| title_short | Current Analytical Strategies for mRNA-Based Therapeutics |
| title_sort | current analytical strategies for mrna based therapeutics |
| topic | messenger RNA quality attributes electrophoresis chromatography mass spectrometry sequencing |
| url | https://www.mdpi.com/1420-3049/30/7/1629 |
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