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.
Pharma
From small molecule metabolism, bioanalysis quantification, to early ADME, find out how today's top researchers spend their day using mass spectrometry to drive the drug discovery pipeline. Because every day is a different day in drug research.
Is “right first time, every time” a pipedream for metabolite identification by LC-MS?
If we lived in an ideal world, it would be possible to unambiguously identify metabolites using a single analytical experiment. This analytical technique would need to be efficient and easily generate the information needed from a routine assay that is also robust, enabling confident decision-making during drug discovery.
Metabolite identification and peace of mind
Managing metabolite identification (Met ID) studies is challenging, so what is at the top of your priority list as you plan the year ahead? Ensuring you have the data needed to manage product safety, meeting deadlines, staff recruitment and training, maintaining compliance, capital expenses, or something else?
The costly consequences of unplanned downtime
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
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.
Selecting the right system for bioanalytical quantitation
Investing in a new LC-MS system is not an easy decision, especially if you have a range of analytical requirements in your laboratory. This blog is part of a series intended to help you choose the right system for your pharmaceutical research and development needs.
Want to accelerate your drug discovery workflow?
Bringing a new drug to market is a costly and complex process. With potentially hundreds of thousands of new compounds to screen during drug discovery, sample throughput is a common bottleneck for pharmaceutical companies. So how do you overcome this barrier?
Selecting the right system for metabolite identification
So, you need a new liquid chromatography-mass spectrometry (LC-MS) system for your metabolite identification (metID) studies, and you are not sure which option is right for you. This blog provides an overview of the metID solutions offered by SCIEX, so you can make the best decision for your organization.
N-Methyl Pyrollidone
I am in the process of analyzing nitrosamines using QTRAP. One of the difficulties in my sample preparation would be using NMP as solvent to dissolve the material. Is it safe to inject approximately 10ul of NMP is QTRAP??
Easing the demands of a compliant pharmaceutical laboratory
At SCIEX, we are proud to provide analytical systems to the pharmaceutical industry. We work hard to understand the demands of analytical work and the processes required to develop and manufacture drugs.