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A 2-fold revolution: MS approaches for the bioanalysis of oligonucleotide therapeutics

A 2-fold revolution: MS approaches for the bioanalysis of oligonucleotide therapeutics

by | Apr 29, 2024 | , , , , ,

In 1998, the US Food and Drug Administration (FDA) approved fomivirsen as the first therapeutic oligonucleotide therapeutic. This approval marked a revolution of mechanism of action discovered decades before finally coming to fruition. Since then, the landscape of chemical modifications of oligonucleotides, conjugations and formulations has evolved tremendously, contributing to improvements in stability, efficacy and safety. Today, more than a dozen antisense oligonucleotides (ASOs) and small interfering RNA (siRNA) drugs are on the market, most of which are designated as orphan drugs for treating rare genetic diseases.

The costly consequences of unplanned downtime

The costly consequences of unplanned downtime

by | Jan 18, 2024 | , , , , , , , ,

Unplanned downtime is a formidable adversary that businesses across various industries strive to minimize. Defined as the unexpected interruption of regular operations, unplanned downtime can wreak havoc on productivity, profitability and customer satisfaction. In this article, we delve into the causes of unplanned downtime, its far-reaching consequences and strategies to mitigate its impact.

Overcoming N-nitrosamine analysis challenges with mass spectrometry and chromatography solutions

Overcoming N-nitrosamine analysis challenges with mass spectrometry and chromatography solutions

by | Sep 6, 2023 | , , ,

N-nitrosamine analysis has raised significant concerns in the pharmaceutical industry since 2018, when these potential carcinogens were found in several angiotensin II receptor blockers (sartans). Subsequent discoveries in ranitidine and some slow-release metformin medications prompted widespread product recalls. The industry has implemented stricter manufacturing requirements and intensified efforts to evaluate and control N-nitrosamine contamination. To meet stringent regulatory requirements, it is essential to develop effective chromatography and mass spectrometry (MS) methods for N-nitrosamine analysis. This blog addresses the challenges associated with detecting N-nitrosodimethylamine (NDMA) in metformin drug products.

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The SCIEX clinical diagnostic portfolio is For In Vitro Diagnostic Use. Rx Only. Product(s) not available in all countries. For information on availability, please contact your local sales representative or refer to www.sciex.com/diagnostics. All other products are For Research Use Only. Not for use in Diagnostic Procedures. Trademarks and/or registered trademarks mentioned herein, including associated logos, are the property of AB Sciex Pte. Ltd. or their respective owners in the United States and/or certain other countries (see www.sciex.com/trademarks).

Echo and Echo MS are trademarks or registered trademarks of Labcyte, Inc. in the United States and other countries, and are being used under license.
Empower is a trademark of Waters Corporation used under license. © DH Tech. Dev. Pte. Ltd.

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