We bring high-value technologies designed to solve critical, analytical problems. We enable profound discoveries, optimize lab operations and ensure regulatory compliance. We help customers turn global industry challenges into the medicines that offer hope.
To ensure compliance success in a changing regulatory landscape, laboratories must continually adapt. Learn how the compliant-ready Waters BioAccord LC-MS platform helps biopharma address the additional compliance challenges posed by the field’s complex analytical instruments.
During 2020, we collaborated with many of our customers to develop targeted liquid chromatography–mass spectrometry/mass spectrometry (LC-MS/MS) methods to detect SARS-CoV-2 (the virus that causes COVID-19) from biological samples. However, the combination of the biological specimen, the sample collection medium, the viral load threshold, and the need for a high throughput method gave rise to…
Oligonucleotides, or short strands of DNA or RNA, continue to increase in popularity. In addition to their essential role as primers and probes in the expanding clinical DNA testing and diagnostics market, they’re also seeing great success as new gene-based therapeutics that hold tremendous promise. With a string of recent drug approvals, including the first…
As scientific advances continue to carry researchers into new arenas, it is vital that technology evolves in tandem. At Waters, we understand that it is only by leveraging fit-for-purpose technologies that researchers are able to unleash their creativity and make pioneering scientific breakthroughs. Scientists working within the rapidly growing biopharmaceutical industry are no exception. With…
In July 2018, the European Medicines Agency (EMA) reported the recall of a number of products containing the active pharmaceutical ingredient (API) valsartan due to contamination with a known carcinogen, dimethyl nitrosamine, also referred to as N-nitroso dimethylamine (NDMA). This action set off a chain of events that led to similar notifications of recalls for…
Since the early 2000s and the advent of the first guidance relating to mutagenic impurities developed by the European Medicines Agency (EMA), it has been necessary to assess the risk posed by mutagenic impurities. Although initially it was thought that avoidance was an option, it quickly became apparent that this was not a viable strategy. …
Learn how to bring increased confidence to your sample preparation workflows using automation, smart lab tools and electronic documentation from Waters. This blog post was revised in September 2023 to include the most up-to-date information.
OneLab, cloud-native laboratory software, allows members to securely design and implement sample preparation protocols for lab analysts. Learn more by reading this post, which was revised in September 2023 to include the most up-to-date information.
Bring increased confidence in sample preparation workflows with OneLab, which enables you to track a lab analyst’s completion of an experiment. Read this blog post, revised in September 2023 to include the most up-to-date information, to learn more!
Glycosylation is an important post-translational modification that can impact the safety and efficacy of protein therapeutics and is therefore one of the most analyzed product attributes during development and quality control. In released N-glycan analysis, glycans are cleaved from proteins via enzymatic digestion and are chemically derivatized for relative quantification by liquid chromatography coupled to fluorescence and mass spectrometry, or capillary electrophoresis with laser-induced fluorescence detection. The inherent challenges of N-glycan analysis have pushed the industry to improve upon…
When a crisis occurs, hindsight is a great teacher. Any company developing or manufacturing products that impact human health can learn from the recent nitrosamine impurity contamination of angiotensin II receptor blockers (ARBs) by reviewing their own quality processes for risks that could result in a similar contamination issue. Analytical data should assure confidence in…
From fundamental research to routine analysis, Waters’ latest innovations in mass spectrometry enable our customers to gain – and apply – insights across the scientific spectrum. Beginning with fundamental research where the focus is on unraveling molecular complexity, new enhancements to the SELECT SERIES™ Cyclic IMS now support a combination of fragmentation and imaging strategies…