Norovirus virus-like particles (VLPs) are structurally heterogeneous, built from a single capsid protein that self-assembles into multiple geometries, making full characterization by conventional mass spectrometry (MS) extremely difficult. A recent bioRxiv paper by Dr. Charlotte Uetrecht and colleagues at the Centre for Structural Systems Biology (CSSB) in Hamburg, Germany, in collaboration with Waters scientists, demonstrates…
For decades, mass spectrometry (MS) developers and users have lived with a familiar trade‑off. Instruments designed for the highest analytical sensitivity often come with implicit costs: fragility, frequent maintenance, and performance that drifts under the pressures of routine use. Conversely, the most robust systems have sometimes been viewed as blunt tools—reliable workhorses, but lacking the…
Most AI projects fail. The organizations that succeed are the ones that build governance before they build velocity. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Artificial intelligence (AI) is poised to take routine work and shift it to fully automated workflows. Currently, 80% of AI projects fail.1 As with most paradigm-shifting technology, it…
Inspecting AI is not new to regulators. The expectations are already well-established. The key question is whether your organization can reliably demonstrate them. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Exploring artificial intelligence (AI) and machine learning (ML) in regulated laboratories governed by Current Good Manufacturing Practices (CGMP) may be new for your…
Why 2026 marks the shift from guidance to enforcement and what it means for your organization now. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Regulators are already inspecting AI use, how prepared is your organization? For years, the pharmaceutical industry has anticipated regulatory clarity on the use of artificial intelligence (AI) and machine…
As clinical LC‑MS adoption continues to grow across toxicology, endocrinology, therapeutic drug monitoring, and metabolic testing, laboratories face an increasingly difficult challenge: delivering results that are not only sensitive, but routine, reproducible, and economically sustainable. While investment decisions often focus on mass spectrometry (MS) detection, experience across clinical laboratories shows that chromatography is frequently the…
When variability appears in clinical liquid chromatography-mass spectrometry (LC‑MS) data, the mass spectrometer is often the first place that laboratories look. Changes in signal intensity, quantitative drift, or failed batches are frequently attributed to detector performance, ion optics, or acquisition settings. Chromatography is often the root cause of the variability observed at the mass spectrometer….
Stage 3 verification: Establishing and maintaining a state of control In pharmaceutical quality control (QC), consistency should mean more than an analyst ending a shift relieved that the results were repeatable and there were no obvious failures. It should mean having enough confidence in the process, the controls, and the data to know that those…
In clinical liquid chromatography-mass spectrometry (LC‑MS), sensitivity and specificity often dominate the conversation. But behind every reliable result is a less visible parameter that determines whether workflows scale smoothly or struggle under pressure: retention time stability. As clinical laboratories increasingly rely on LC‑MS for high‑throughput, multi‑analyte testing, retention time stability has become a defining factor…
Audit readiness isn’t a last-minute activity triggered by validation or inspection. It’s established much earlier, at method design, through the scientific understanding, risk-based control, and documentation needed to demonstrate that a method is fit for purpose and capable of performing consistently over time. If those elements aren’t built in from the outset, gaps are likely…
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…
Oligonucleotide therapeutics continue to grow in complexity, and so do the purification challenges that come with them. Scientists need reliable, scalable solutions for preparative oligonucleotide purification. MaxPeak Premier Oligo OBD Columns provide a powerful solution for these workflows, now expanded to include 19mm ID formats. These columns reduce non-specific adsorption, improve recovery, and enable consistent…