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Updated: Nov 2, 2025

Targeted RNA Sequencing Assay to Characterize Gene Expression and Genomic Alterations
Published on: August 4, 2016
Analytical techniques currently used in the pharmaceutical industry for the quality control of RNA-based therapeutics
Alice Demelenne1, Anne-Catherine Servais1, Jacques Crommen1
1Laboratory for the Analysis of Medicines, Department of Pharmacy, Center for Interdisciplinary Research on Medicines (CIRM), University of Liege, Quartier Hôpital, Avenue Hippocrate 15, CHU, B36, Liege 4000, Belgium.
Abstract:
The number of RNA-based therapeutics has significantly grown in number on the market over the last 20 years. This number is expected to further increase in the coming years as many RNA therapeutics are being tested in late clinical trials stages. The first part of this paper considers the mechanism of action, the synthesis and the potential impurities resulting from synthesis as well as the strategies used to increase RNA-based therapeutics efficacy. In the second part of this review, the tests that are usually performed in the pharmaceutical industry for the quality testing of antisense oligonucleotides (ASOs), small-interfering RNAs (siRNAs) and messenger RNAs (mRNAs) will be described. In the last part, the remaining challenges and the ongoing developments to meet them are discussed.
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