LC-MS

  • Why Chromatography Still Matters in the Age of More Sensitive Mass Spectrometry

    By Debbie Francis Reading Time: 4 minutes

    Mass spectrometry (MS) is more powerful than ever. Modern clinical MS systems deliver extraordinary analytical sensitivity, selectivity, and quantitative performance, opening the door to broader test menus with lower detection limits. With capabilities like these, it’s tempting to ask a simple question: Does chromatography still matter as much as it used to? The short answer…

  • What’s Really Happening to Your rAAV Under Stress?

    By Kate Yu Reading Time: 2 minutes

    Ensuring the stability of recombinant adeno-associated virus (rAAV) vectors remains a central challenge in gene therapy development. rAAV particles are structurally complex, highly heterogeneous, and sensitive to environmental stress, making it difficult to link analytical changes to functional consequences during manufacturing and storage. A recent Journal of Pharmaceutical Sciencesstudy by Prof. Susumu Uchiyama and colleaguesat…

  • Enzymatic Digestion: Accelerating Bioseparations with Novel Enzymes

    By Elizabeth Foley Reading Time: 4 minutes

    The Role of Enzymes in LC-MS Analysis of Modern Biotherapeutics  Enzymes are nature’s catalysts, enabling precise and efficient biochemical transformations. In analytical workflows, enzymatic digestion is a cornerstone technique for breaking down complex biomolecules into smaller, more manageable fragments. This process is critical for applications such as peptide mapping in protein characterization and oligonucleotide mapping…

  • FDA October 2025 Draft Guidance Sparks Industry Biosimilars Buzz 

    By David Curtin Reading Time: 5 minutes

    The FDA’s October 29, 2025 draft guidance has generated significant attention due to the implications for both developers and patients.  By allowing developers to bypass comparative efficacy studies (CES) when advanced analytics are successful substitutes, the draft guidance avoids one of the most expensive steps, estimated to account for 70% of the total biosimilar development…

  • How Advances in Bioanalysis Drive Scientific and Ethical Progress

    By Nikunj Tanna Reading Time: 3 minutes

    How Sygnature Discovery Supports the 3Rs with LC-MS/MS Scientific Precision and Ethical Innovation In the world of drug discovery, researchers face a critical challenge: how do you generate high-quality, reproducible bioanalytical data while minimizing the ethical and logistical burden of using animals in testing?  This is especially so with central nervous system (CNS) drug discovery,…

  • Biophysical Characterization Methodologies

    By Donald Mason Reading Time: 7 minutes

    Biophysical characterization of proteins is a necessary step in the production and development of protein therapeutics, as it allows for a comprehensive understanding of a protein’s function and structure. By analyzing and defining the higher-order structure of potential drug targets, this process serves to identify and mitigate issues that could significantly impact the efficacy and safety of a product, such as…

  • The IVDR Cake. We’ve got a slice!

    By Donald Mason Reading Time: 3 minutes

    Healthcare Providers and medical device manufacturers alike are working diligently to ensure that their services and products are compliant with these new regulations in the medical device industry in the European Union (EU).