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.

  • Waters GlycoWorks RapiFluor-MS N-Glycan Kit Improves Reproducibility and Speed of N-Glycan Analysis Through Innovation and Automation

    By Xiao Dong Reading Time: 4 minutes

    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…

  • The Impact of Complex Global Supply on the Nitrosamine Crisis

    By Heather Longden Reading Time: 4 minutes

    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…

  • Reveal Molecular Secrets – and Set Them to Work!

    By Ronan O'Malley Reading Time: 3 minutes

    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…

  • Setting a New Bar for Benchtop Automation

    By Waters Staff Reading Time: 3 minutes

    Laboratory automation is quickly becoming a critical component of the modern lab, streamlining pharmaceutical, life science and analytical LC-MS workflows.  Automation of routine and complex sample preparation helps minimize variability, improve traceability and simplify method transfer, ultimately bringing improved efficiency to the lab and allowing scientists to spend more time on value-added tasks. Despite this,…

  • Navigating the Uncertainties of the Nitrosamine Impurity Crisis

    By Waters Staff Reading Time: 3 minutes

    The nitrosamine impurity crisis continues to be on the mind of every stakeholder involved in the development and manufacturing of affected drug products. In our interactions with key opinion leaders and those in the lab having to develop and validate nitrosamine testing methods, we’ve come across a few common questions that we want to address here

  • Controlling Analytical Method Variability with Key Approaches to Sample Handling and Preparation

    By Waters Staff Reading Time: 6 minutes

    Sample handling and preparation can have a substantial effect on an analytical method’s variability and data quality.  It is important to consider and address the risks associated with sample preparation as part of the method development process.  This requires carefully designed and executed experiments and clear documentation in the method to give the analyst an…

  • 5 Peptide Bioanalysis Sample Preparation Challenges (and how to overcome them!)

    By Kim Haynes Reading Time: 3 minutes

    Scientists that have worked with peptides understand that peptide quantification can be challenging. One of the keys to successful peptide analysis is thorough and selective sample preparation. Sample preparation improves various aspects of chromatography and mass spectrometry analyses by utilizing solid phase extraction (SPE) to chemically separate different analytes and aid in removing the interfering…

  • Nitrosamine Impurities: The Need to Verify

    By Waters Staff Reading Time: 3 minutes

    The recent nitrosamine impurity crisis has brought into question the quality of many APIs (Active Pharmaceutical Ingredients) produced and sourced for a number of popular drugs, resulting in product recalls, lost profits, and regulatory actions. Within a drug manufacturing process that is increasingly outsourced and globalized, companies manufacturing the API or in-sourcing the API or…

  • Webinar Highlights – Improving Analytical Method Performance Through Quality Risk Management and a Design of Experiments Approach

    By Sarah Slapak Reading Time: 4 minutes

    In our most recent Method Lifecycle Management webinar held Improving Analytical Method Performance Through Quality Risk Management and a Design of Experiments Approach, Joseph A. Turpin, Director of Chromatography Products and Services at S-Matrix Corporation and Tran Pham, Business Development Manager at Waters Corporation, presented an overview of Quality by Design approaches to analytical method development (AQbD), the regulatory views on this approach, examples of design of experiments in AQbD, and case studies demonstrating software assisted AQbD method development.

  • Mobile Phase Additives for Peptide Characterization

    By Waters Staff Reading Time: 3 minutes

    The characterization of peptides and proteins can be challenging due to issues such as adsorption, varying hydrophobicities, and specificity to name just a few. When analyzing peptides by Liquid Chromatography (LC) and Mass Spectrometry (MS), it’s beneficial to introduce mobile phase additives in order to facilitate ionization and enhance the analyte signal. Additionally, these additives…

  • More than a slogan, bioharmonization is a unifying principle that aims to enhance productivity

    By Joe Fredette Reading Time: 3 minutes

    In January of 2018, Waters kicked off its global Bioharmonization campaign with a blog post and video release, laying out a vision for how the Biopharmaceutical industry can achieve accelerated development and improved quality while enhancing productivity and lowering production costs. Central to this vision are “fit-for-purpose” analytical tools working together within a single compliance-ready…

  • What do great vacations and peptide bioanalysis have in common?

    By Ian Edwards Reading Time: 5 minutes

    For starters no one wants a disastrous vacation, the same goes for a bioanalysis assay! What makes for a great vacation? A booking agent who understands you, on time transit, a room with a view a stones throw from the beach, friendly staff and great cuisine? Knowing that you are in safe hands and leaving…