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J Chromatogr A ; 1651: 462283, 2021 Aug 16.
Artigo em Inglês | MEDLINE | ID: mdl-34107400

RESUMO

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.


Assuntos
Química Analítica , Indústria Farmacêutica , RNA de Cadeia Dupla/normas , RNA de Cadeia Dupla/uso terapêutico , Ensaios Clínicos como Assunto , Guias como Assunto , Humanos , Controle de Qualidade , RNA de Cadeia Dupla/química
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