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FDA October 2025 Draft Guidance Sparks Industry Biosimilars Buzz
The FDA’s October 29, 2025 draft guidance has generated significant attention due to the implications for both developers and patients.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developers to bypass comparative efficacy studies (CES) when advanced analytics are successful substitutes, the draft guidance avoids one of the most expensive steps, estimated to account for 70% of the total biosimilar development
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FDA October 2025 Draft Guidance Sparks Industry Biosimilars Buzz
The FDA’s October 29, 2025 draft guidance has generated significant attention due to the implications for both developers and patients.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developers to bypass comparative efficacy studies (CES) when advanced analytics are successful substitutes, the draft guidance avoids one of the most expensive steps, estimated to account for 70% of the total biosimilar development...
Slalom Chromatography: A High-Speed Path to Nucleic Acid Separation
Slalom chromatography is no longer just a scientific curiosity, it’s a comeback story. Once sidelined due to limited reproducibility and unclear mechanisms, this technique is now gaining momentum thanks to the rise of nucleic acid therapeutics and advances in UHPLC systems. But its revival wasn’t accidental. It took a year-long deep dive into DNA physics,...
Is Your LIMS Holding Your Lab Back? Why a LIMS Alone Isn’t Enough
Laboratory information management systems (LIMS) are often hailed as the cornerstone of modern lab operations, central to digital transformation and essential for regulatory compliance. They’re positioned as the “digital backbone” of the lab, helping manage samples, data, and routine workflows. And in many ways, that reputation is well-earned. But here’s the reality: A LIMS alone...
Solid-Phase Extraction: From Sample Prep Fundamentals to Best Practices
Chromatography and mass spectrometry sample preparation is one of the most critical (and underrated) steps in analytical chemistry—ensuring samples are clean and concentrated enough for accurate, reproducible analysis. Shortchanging sample preparation can compromise data accuracy, reduce method robustness, and even cause timely downtime of expensive instrumentation when it matters most. What Are the Challenges in...
Achieving SOC 2 Type II Compliance: A Milestone in Customer Trust and Security
We are pleased to announce that Waters Corporation has successfully achieved SOC 2® Type II attestation for the waters_connect Cloud software platform, in accordance with the American Institute of Certified Public Accountants (AICPA) standards. This accomplishment reflects our unwavering commitment to safeguarding customer data, building trust, and upholding the highest standards of security, availability, and...
Xevo MRT System in Action: Driving Innovation in Mass Spectrometry
Analytical labs today face mounting pressure: ever more complex samples, rising regulatory demands, and the need to generate answers faster than ever. Traditional mass spectrometry approaches can require compromises, either in data quality or in analytical efficiency, making it harder for scientists to meet demanding timelines with full confidence in their results. Waters XevoTM MRT...
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