Measurement of mRNA therapeutics: method development and validation challenges
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Updated: Jan 5, 2026

Probe-based Real-time PCR Approaches for Quantitative Measurement of microRNAs
Published on: April 14, 2015
Neil Henderson1, Amanda Wilson2
1Translational Biomarkers & Bioanalysis, Clinical Pharmacology Biologics & Bioanalytics, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Abstract:
The progression of chemically modified mRNA therapeutics through development pipelines is accelerating for many disease indications and the need to assess these analytes is becoming more routine for the pharmaceutical industry and contract research organizations. This article describes some of the challenges and strategies for performing regulated bioanalysis of modified mRNA therapeutics by comparing the two main analytical approaches - quantitative reverse transcription PCR and branched DNA.
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