Pharmaceutical

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.

  • Biopharma’s Future: Next-Generation LC-MS Workflows for Peptide MAM

    By Scott Berger Reading Time: 7 minutes

    The development of biotherapeutics continues to accelerate with their potential to revolutionize disease treatment in areas not adequately addressed by small molecule therapeutics. However, the complexity of these macromolecules and the range of potential modification variants (attributes) creates an interesting analytical challenge for scientists tasked with their characterization and then with monitoring those attributes important…

  • Embracing Analytical Techniques Into Regulated Laboratories

    By Heather Longden Reading Time: 5 minutes

    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.

  • Comprehending COVID-19: How Consumables Can Increase LC-MS/MS Sensitivity

    By Hazel Dickson Reading Time: 4 minutes

    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…

  • Answering the Call with Compliance-Ready LC-MS Solutions for Oligonucleotide Analysis

    By Joe Fredette Reading Time: 5 minutes

    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…

  • Boosting Biopharma Productivity with Routine LC-MS

    By Steve Preece Reading Time: 5 minutes

    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…

  • The Evolving Regulations Guiding Nitrosamines

    By Andy Teasdale Reading Time: 5 minutes

    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…

  • Mutagenic Impurity Risk Assessment Throughout the Development and Manufacturing Process

    By Andy Teasdale Reading Time: 4 minutes

    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. …