A systematic approach for formation of sigmoidal gradient for analysis of biopharmaceutical proteins has been reviewed and discussed together with two case studies. The first application involves HPLC separation of the various product related variants of a microbial expressed biotherapeutic, granulocyte colony stimulating factor (GCSF). The second case study involves separation of the charge heterogeneity related variants for a monoclonal antibody (mAb) biotherapeutic product. In all cases, it is observed that the use of sigmoidal gradient successfully reduces the analysis time significantly (from 70 minutes to 15 minutes for GCSF and from 40 minutes to 4 minutes for the mAb) while retaining the selectivity and the resolution.
The development of various analytical MS methods to investigate the chemical composition of liquids used in electronic cigarettes and characterize their quality is presented in this study.
Simple, rapid and accurate methods have been developed for the analysis of simple carbohydrates including mono- or disaccharides, or as fairly small glycans (6–11 residues) liberated from glycoproteins using charged aerosol detection combined with mass spectrometry techniques.
Insulin was the first recombinant pharmaceutical produced. Currently, one of the critical quality control attributes of therapeutic insulin in the US and European Pharmacopoeia (USP and EP) monograph is the level of covalent high molecular weight (HMW) insulin as determined by HPLC size-exclusion chromatography.
The use of electrospray ionization–mass spectrometry for rapid and specific determination of the widely used metal deactivators Irgamet-30 and Irgamet-39 is demonstrated here.
The FDA has made changes to how products containing sunscreen are labeled in the U.S. to ensure they meet the new regulations set forth for safety and effectiveness. The new regulations will require companies that want to use the "broad spectrum" label to test for both UVA and UVB protection.
This article compares results from samples prepared and analyzed according to EPA Method 1613B on a sector instrument with those from a high-resolution, accurate mass TOF mass spectrometer and a low-resolution TOF mass spectrometer interfaced to a comprehensive two-dimensional gas chromatography (GC) system (GC?C–TOF-MS).
An application of MALDI-MS in qualitative and quantitative analysis of pharmaceutical compounds spiked in urine is demonstrated.
Advantages of the planar, off-line format of TLC relative to on-line column HPLC, the steps in TLC analyses, and future prospects of TLC are discussed.
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Trypsin is one of the most commonly used proteases in peptide mapping protocols because of its high level of specificity. However, trypsin alone is not always sufficient for full sequence coverage. In this article, the authors detail how trypsin was combined with chymotrypsin to overcome this, and the benefits of an automated platform.
This work describes a simple and sensitive high performance liquid chromatography (HPLC) method with mass spectrometry (MS) and ultraviolet (UV) detection for the analysis of mixtures of up to 32 pesticides.
Analysis of chromium species is made challenging due to the nature of the element and diverse sample matrices
A novel "green chromatography" method for analysing melamine in milk is described. The method uses 100% water as the eluent and in the sample preparation stage and is reported to be a reliable and cost-effective method for laboratories in developing countries.
Monoclonal antibodies (mAbs) are being developed at an explosive rate and have attracted great interest from both smaller biotech firms and big pharmaceutical companies. Developing mAbs and next-generation antibody–drug conjugates (ADCs) is highly demanding in many ways. From an analytical perspective, handling mAbs and ADCs presents many new challenges. This article describes how size-exclusion chromatography (SEC) combined with high-resolution mass spectrometry (HRMS) can be applied to the detailed characterization of mAbs and ADCs.
A look at the LC and LC–MS methods that are helping to overcome challenges in sample analysis, and how this can make adeno‑associated virus (AAV)–based gene therapy more accessible.
In on-site environmental applications, representative sampling and proper replication are essential. For these reasons, recent work in thin-film solidphase microextraction has focused on the development of unique holders and customized samplers that are tailored for distinct sampling environments. Here, we explore the latest developments.
This article describes the analysis of fluorescently labelled N-glycans released from proteins by liquid chromatography–mass spectrometry (LC–MS).
HPLC with diode-array and electrochemical-array detection overcomes sensitivity and specificity limitations in natural products analysis.
The analysis of PAHs in less than 16 min using hydrogen as carrier gas and the PerkinElmer? Clarus? SQ 8 GC/MS operating in SIM mode is presented. Detection limits down to 0.5 pg on-column and a wide dynamic range are reported.
A new technique was developed based on liquid chromatography coupled with tandem mass spectrometry to analyze drugs that are not part of current immunoassay screening, specifically zolpidem, zopiclone, and zaleplone, or "z-drugs."
Current advances in commercial pressurized-fluid extraction (PFE) instrumentation are discussed, along with the advantages of performing PFE prior to chromatographic analysis.
A breakthrough using a microfluidic interface to conduct sensitive time-of-flight secondary ion mass spectrometry (TOF-SIMS) analysis and study liquid surfaces in situ under vacuum conditions is described here.
When working with complex matrices such as personal care products, sample preparation is perhaps the most difficult step of the analysis process. By utilizing a targeted sample preparation technique, such as ion-exchange SPE, analysis can be significantly improved as compared to less targeted techniques such as liquid-liquid extraction.
A dedicated GC– MS analyser was developed to address the increasing need for more sensitive catalyst poisoner analysis. The system combines the separation power and robustness of a classic backflush configuration with the selectivity and sensisitivitiy of mass spectrometry.
Thermo Scientific Application Note