Analytical techniques currently used in the pharmaceutical industry for the quality control of RNA-based therapeutics and ongoing developments.


Journal

Journal of chromatography. A
ISSN: 1873-3778
Titre abrégé: J Chromatogr A
Pays: Netherlands
ID NLM: 9318488

Informations de publication

Date de publication:
16 Aug 2021
Historique:
received: 08 02 2021
revised: 14 05 2021
accepted: 18 05 2021
pubmed: 10 6 2021
medline: 23 7 2021
entrez: 9 6 2021
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 34107400
pii: S0021-9673(21)00407-6
doi: 10.1016/j.chroma.2021.462283
pii:
doi:

Substances chimiques

RNA, Double-Stranded 0

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

462283

Informations de copyright

Copyright © 2021. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have influenced the work reported in this paper.

Auteurs

Alice Demelenne (A)

Laboratory 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.

Anne-Catherine Servais (AC)

Laboratory 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.

Jacques Crommen (J)

Laboratory 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.

Marianne Fillet (M)

Laboratory 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. Electronic address: marianne.fillet@uliege.be.

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Classifications MeSH