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…
The FDA’s October 29, 2025 draft guidance has generated significant attention due to the implications for both developers and patients.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developers to bypass comparative efficacy studies (CES) when advanced analytics are successful substitutes, the draft guidance avoids one of the most expensive steps, estimated to account for 70% of the total biosimilar development…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 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,…
New OligoWorks Solid Phase Extraction (SPE) Kits for extraction and bioanalysis of oligonucleotides deliver advantages over liquid-liquid extraction (LLE) and other existing SPE kits and sample preparation methods. Read on to discover how.
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).
The Waters MassTrak Immunosuppressant Calibrator, Control, and Internal Standard Sets, soon available, are developed to help laboratories utilize LC-MS/MS with confidence in their assay results.
Our MassTrak IVD solutions provide customers with a range of instrumentation, reagent kits and informatics that can be configured to support laboratory workflows ensuring regulatory compliance.
Recent developments in techniques for rapid and efficient oligonucleotide synthesis and molecular biology technology have expanded the market for manufacturers and service providers in the field. Liquid chromatography coupled with mass spectrometry (LC-MS) workflows play a critically important role.
![Attribute Monitoring Workflows [Infographic]](https://www.waters.com/blog/wp-content/uploads/feature-image-768x758.png)
Learn how the BioAccord LC-MS System is instrumental in the drug development workflow from sample prep to reporting.
Combining BioAccord, our most capable MS detection platform, with ACQUITY Premier UPLC, our highest performance LC system, to demonstrate superior performance.
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…
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.