Literature DB >> 31657232

Measurement of mRNA therapeutics: method development and validation challenges.

Neil Henderson1, Amanda Wilson2.   

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.

Keywords:  branched DNA (bDNA); modified messenger RNA (mRNA); quantitative reverse transcription PCR (qRT-PCR); regulatory bioanalysis

Mesh:

Substances:

Year:  2019        PMID: 31657232     DOI: 10.4155/bio-2019-0120

Source DB:  PubMed          Journal:  Bioanalysis        ISSN: 1757-6180            Impact factor:   2.681


  1 in total

1.  A Fit-for-Purpose Method to Measure Circulating Levels of the mRNA Component of a Liposomal-Formulated Individualized Neoantigen-Specific Therapy for Cancer.

Authors:  Sebastian Guelman; Ying Zhou; Ann Brady; Kun Peng
Journal:  AAPS J       Date:  2022-05-02       Impact factor: 4.009

  1 in total

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