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…
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…
Understanding how bacterial proteasomes recognize and process their substrates remains a major challenge in infectious disease biology and drug discovery. In Mycobacterium tuberculosis, this challenge is particularly critical, as the proteasome is essential for bacterial survival inside host macrophages and represents an attractive antibacterial target. A recent Nature Communications study by Prof. Siavash Vahidi and…
Adeno-associated virus (AAV) vectors are widely used in gene therapy because of their ability to enable long-term transgene expression with favorable safety profiles. However, immune responses to the AAV capsid remain a major barrier, limiting treatment durability and the feasibility of repeat dosing. A recent Nature Communications study led by Dr. Ronit Mazor and colleagues…
For many laboratories, the conversation around cloud and SaaS software has shifted from if to when. The benefits are well understood—reduced infrastructure, greater flexibility, and continuous updates—but the decision itself is rarely simple. Moving to the cloud is not just a technical change. It reshapes how your lab operates, scales, and collaborates. The key is…
In hospital intensive care units, insulin is a critical therapeutic used to maintain tight glycemic control. While it is typically supplied at 100 units/mL, clinical protocols dilute it to 1 unit/mL for continuous infusion, commonly known as the insulin infusion protocol (IIP). At these low concentrations, ensuring stability becomes challenging, especially when aggregation or surface…
Solid‑core (or superficially porous) particles are the foundation of solid core HPLC columns and have earned a reputation for delivering higher efficiency separations than similarly sized, fully porous particles. Chromatographers see this play out repeatedly across small- and large-molecule applications under a wide range of operating conditions. But why solid‑core particles are more efficient is…