The FDA’s October 29, 2025 draft guidance has generated significant attention due to the implications for both developers and patients.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developers to bypass comparative efficacy studies (CES) when advanced analytics are successful substitutes, the draft guidance avoids one of the most expensive steps, estimated to account for 70% of the total biosimilar development…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,…
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.
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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.
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…
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…
What does “intelligence” mean in the context of biopharma analysis? Given the complex setting, much of the answer comes down to the task a user needs to complete, along with the question of who exactly that user is. In developing our BioAccord System, we wanted to expand the possibilities of high-resolution LC-MS analysis from characterization…
There’s no question that we’ve entered the age of smart technology. Your phone, your home, your refrigerator, even your light bulbs are all getting smarter. Such technologies do more and more to run themselves, removing steps and complexity, while making user interactions easier and more intuitive. They continually improve, and as they do they become…