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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Main Authors: Julien Camperi, Kamalakar Chatla, Emily Freund, Carolina Galan, Steffen Lippold, Axel Guilbaud
Format: Article
Language:English
Published: MDPI AG 2025-04-01
Series:Molecules
Subjects:
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.
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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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