In biotherapeutics manufacturing, controlling size variants of therapeutic monoclonal antibodies (mAbs) is critical for ensuring product quality.
An UHPLC–MS research prototype instrument was built to improve the resolution power and the usability of conventional LC–MS hyphenated instruments for routine analyses in pharmaceutical applications.
The author describes the benefits of using high-capacity sorptive extraction and statistical analysis to detect authenticity markers and combat food fraud in honey samples.
High-resolution mass spectrometry (HRMS) is an increasingly critical tool for identifying, characterizing, and monitoring attributes of protein-based therapeutics.
***Live Dates: Tuesday, November 10, 2020 at 2pm EST| 1pm CST| 11am PST, and Thursday, November 12, 2020 at 2pm EST| 1pm CST| 11am PST***Learn the importance of accurate and reliable THC and CBD concentration results and the tools available to provide that data from an industry insider. ***On demand available after final airing until Nov. 12, 2021***
Improved analysis of pharmaceutical and natural medicine products requires advances in reversed-phase LC stationary phases. We examine two synthesized stationary phases with applicability in quality control and chiral separation for analysis of natural products.
This article introduces a multi-step preparative purification workflow for synthetic peptides using liquid chromatography–mass spectrometry (LC–MS). The process involves optimizing separation conditions, scaling-up, fractionating, and confirming purity and recovery, using a single LC–MS system. High purity and recovery rates for synthetic peptides such as parathormone (PTH) are achieved. The method allows efficient purification and accurate confirmation of peptide synthesis and is suitable for handling complex preparative purification tasks.
In the pharmaceutical industry, method validation is essential. But what are the best practices? We review regulatory requirements, validation parameters, methodologies, acceptance criteria, trends, and software tools.
A recent trend in the design of LC instrumentation is the move towards miniaturized and portable systems.
New gene therapy modalities, such as CRISPR guide RNA (single guide ribonucleic acid [sgRNA]) and messenger RNA (mRNA), continue to make progress in both primate and first-in-human trials. As this progress builds, the industry remains accountable for characterizing these molecules to meet the requirements of regulatory authorities.
This month's installment of "CE Currents" deals with problems that may arise when using capillary electrophoresis for unattended, long-term operation, such as sample carryover, evaporation effects, capillary conditioning, capillary surface changes, buffer handling, capillary breakage, and detector lamp deterioration.
Limitations often arise when using GC with quadrupole-based mass spectrometers for detecting volatile and semivolatile contaminants. Enter HRAMS-MS.
In the first LCGC Blog of 2025, Caitlin Cain of the University of Michigan highlights the divide between gas and liquid chromatographers, and why both types of techniques should be in the same conversations.
This month's "Directions in Discovery" gives a brief overview of turbulent- flow liquid chromatography, a technique for fast separations. Two examples demonstrate the use of the technology for high-throughput bioanalytical separations in drug discovery.
Analysis of the compositional variation in living cells is essential for understanding biological processes. Single-cell elemental analysis by triple-quadrupole ICP-MS is emerging as a selective, highly sensitive, and potentially high-throughput technique for the study of constitutive elements, and uptake of metallodrugs (or metal-containing nanomaterials) in single cells.
Webinar Date/Time: Thu, Dec 7, 2023 1:00 PM ES
Online SPE–LC–MS/MS combined with the method presented enabled automated cleanup of food extracts and determination of PFAS compounds in the ng/kg range.
The presence of per- and polyfluoralkyl substances (PFAS) in water is an important health and environmental concern. Liquid chromatography–mass spectrometry (LC–MS) has been established as the most suitable technology for monitoring these substances. A method is described, using EPA 8327, for PFAS analysis in groundwater, surface water, and wastewater.
***Live: Day One: Wednesday, February 10, 2021 at 9:30am EST - 4:30pm EST *** Day Two: Thursday, February 11, 2021at 9:30am EST - 4:30pm EST *** Join us for this two-day virtual symposium on data integrity with renowned experts Bob McDowall, Chris Burgess, and Mark Newton. This event is aimed at chromatographers and quality assurance professionals who have a working knowledge of data integrity within a regulated GXP laboratory. ***On demand available after final airing until Feb. 10, 2022***
Better sample preparation and miniaturized separations are enhancing these analyses.
Navin Rauniyar and Xuemei Han of Tanvex Biopharma USA recently discussed how identifying product-related variants through characterization enables the recognition of impurities that compromise the quality and safety of drugs.
High performance anion-exchange chromatography coupled with pulsed amperometric detection (HPAEC-PAD) is a potential method of choice for the analysis of carbohydrates.
How to speed up sample prep time and equivalent acccuracy and precision.
Size-exclusion chromatography (SEC), with the use of ammonium acetate buffer, can be coupled on-line to electrospray ionization MS for the characterization of size variants of therapeutic monoclonal antibodies (mAbs). A quadrupole time-of-flight (QTOF) MS system was employed, and the MS method was optimized to achieve favorable sensitivity for high-mass detection, while maintaining the structural integrity of the aggregates (or high molecular weight species) and fragments (or low molecular weight species).
This article presents a multimodal approach for students with severe visual impairment or blindness, to encourage them to learn more about chromatographic processes.
Ion chromatography (IC) is becoming increasingly important for pharmaceutical applications. In contrast to other technologies, IC can resolve multiple ionic species and polar analytes simultaneously.
Supplementing short pulse lasers with laser postionization increases ionization yields for desorption and ablation of solid samples in mass spectrometry. Here, we give an overview of the mechanisms and technical requirements for molecular photoionization in femtosecond (fs) laser desorption postionization mass spectrometry (LDPI-MS).
This information is supplementary to the article “Accelerating Monoclonal Antibody Quality Control: The Role of LC–MS in Upstream Bioprocessing”, which was published in the May 2025 issue of Current Trends in Mass Spectrometry.
A validated FFF-MALS method aligned with technical specification ISO/TS 21362 for the analysis of lipid-based nanoparticles (LNPs) encapsulating siRNA and mRNA is presented.