Small Molecule Bioanalysis
Analysis of Rosuvastatin in Dried Blood Spots and Plasma Using ACQUITY UPLC with 2D Technology
In the field of bioanalysis, the analysis of a target analyte and its metabolites in biological fluids (urine, plasma, and blood) is predominantly the main activity during animal and human trials. As such, a wide range of extraction and analytical techniques are used for qualitative and quantitative analysis.
From Whiteboard to Reality: How the Start-up Bioanalytical CRO Pushes the Boundaries
In the crowded CRO landscape, being successful means addressing service gaps that can be filled by smaller, dynamic and more flexible organizations. New start-ups need to fully survey products and technologies, and capitalize on those that will allow them to differentiate and to position themselves competitively. Drs. Liz Thomas and Sally Hannam discuss the story of Alderley Analytical's journey from concept to a state-of-the-art GLP-compliant bioanalytical CRO.
High Sensitivity Tandem Quadrupole MS for Quantitative LC-MS/MS Analysis of Low Exposure Pharmaceuticals
Microflow LC-MS in Early Discovery through Development
Microflow LC-MS is a challenge. Only a few do it well, and even fewer do it well consistently. And for those who have had success, their methods can completely fall apart when being transferred to other analysts and labs. Without robustness and the ability to adopt into routine use, microflow LC-MS has remained a tool relegated to research applications. This blog post summarizes the appeal of microflow LC-MS.
RADAR White Paper
Uncertainty in chromatographic method development and quantitative experiments often arise when co-eluting unknown interferences, which reduces performance. This white paper describes the utility of RADAR to attenuate the impact of unknown interferences while maintaining high quality analytical performance.
Large Molecule Quantification
Absolute Quantification of Yeast Kinases by LC-MS/MS using QconCAT and MRM Technologies
Absolute protein quantification by LC-MS/MS is an important tool in assay development and creating data for systems modeling. Enabling predictive biology is one of the primary goals of many system biology studies, achieving detailed knowledge of the cellular constituents, their quantities, dynamics, and interactions.
Analytical Tools to Interrogate and Understand Antibody Drug Conjugates
Antibody Drug Conjugates in Bioanalysis – Survey Infographic
Are Analytical Chemists Going Extinct?
Because Size Matters…ProteinWorks for Large Molecule Quantification
Bioanalysis Zone Spotlight on Antibody-Drug Conjugates
With the potential to allow targeted delivery of anticancer drugs to tumors, with minimal impact on normal tissue, there is increasing interest in ADCs in new drug development. This interest is highlighted by a robust pipeline of ADCs in pre-clinical and clinical development. The heterogeneity and dynamic nature of ADCs raises unique bioanalytical challenges, which is explored as part of Bioanalysis Zone’s Spotlight on ADCs.
Bridging the Gap…Connecting Evolving Bioanalysis Expertise to a Rapidly Changing Global Biopharma Industry
As the pharmaceutical industry continues to shift more toward biologics and hybrid drug entities, it becomes increasingly imperative that the small and large molecule bioanalysis worlds work together to efficiently arrive at go/no-go decisions. This webinar will address these trends as well as the impact on drug development and regulatory requirements for drug approval.
High Resolution Mass Spectrometry Quantitation Explained: Adding Sensitivity and Selectivity Through Instrument Design and Practice
Benchmark studies of the Xevo G2-XS QTof suggests it is >1000 times more sensitive than those introduced just 10 years ago. This jump in improvement can be attributed to both StepWave ion guide technology and a new collision cell design that minimizes background noise, improves ion focusing, and reduces losses in ion transfer.
How Bioanalysts Use and Evaluate the Future of LC-MS
Peptide Bioanalysis Solution Guide
Employing LC-MS for the bioanalysis of peptides requires the extraction of the target analyte from a matrix of biochemically similar proteins and peptides. However, we have seen that the most common techniques employed for small molecule extraction, such as protein precipitation (PPT) and liquid-liquid extraction (LLE), do not provide the recovery, sensitivity, specificity, and assay robustness required. Learn about Waters' sample preparation protocols and separation conditions that will help you quickly and effectively develop methods for any peptide.
Peptides and Proteins are not Small Molecules; Why Treat Them the Same?
Large molecule quantification is one of the greatest challenges that bioanalysts face. Sensitivity and specificity issues are numerous: fewer molecules per volume; increased fragmentation; limited recovery due to complex sample prep; and so on. Learn why Waters is leading the industry in large molecule bioanalysis.
ProteinWorks Application Notebook
This new application notebook contains 9 detailed application notes focused on biologics quantification using LC/MS. ProteinWorks are a set of kits that facilitate the surrogate peptide method (protein digest). This notebook contains key examples of accurate, sensitive, and reproducible quantification of protein therapeutics including mAbs and ADCs.
The Ever-Expanding Role of HRMS in Regulated Bioanalysis
The heights of biopharmaceutical complexity and the current reach of analytical instrumentation
Monoclonal antibodies are currently the fastest growing segment of therapeutic proteins in the pharmaceutical industry, partly due to faster approval rates than small molecules and a large untapped market. Understanding primary structure of the protein with post-translational modifications, can be important to assessing an antibodies efficacy and safety.
The Role of Mass Spectrometry in Biopharmaceutical Drug Discovery and Development
The discovery and development of biopharmaceuticals that target specific diseases can be transformative for people living with illness. However, bringing a new therapy to market is a prolonged and costly process mired in uncertainty. Ensuring safety, efficacy, and product quality is paramount. Biopharmaceuticals, by their nature, are highly complex. A myriad of heterogeneity can be intentionally functional, an unwanted consequence of manufacturing and storage, or generated by biological modification in vivo. Not all, but some post-translational modifications or biotransformations can impact development, manufacturing, safety, efficacy, and overall product quality. These critical quality attributes (CQAs) need to be identified, characterized, controlled, and monitored throughout the drug discovery and development cycle. Specialty measurement using mass spectrometry (MS) continues to play an ever-increasing role across the continuum.
What's New? Microfluidic Separation Devices Coupled to MS
Metabolite Identification
Achieving Femtogram-level On-column Sensitivity for Quantitation of Drugs in Human Plasma
Advances in HRMS have led to improved selectivity, dynamic range, linearity, and sensitivity, In the presence of complex matrix interferences that might prove challenging for triple quadrupole MS approaches, the markedly different nature of HRMS data acquisition can achieve the selectivity and sensitivity for successful quantitation.
Achieving the highest quality data at the lowest levels in detection for Metabolite Identification with Xevo G2-S QTof and UNIFI Software
Comprehensive Sub-2 Minute Metabolite Identification and Characterization Using Xevo G2 Tof and MSE
This technical brief outlines a simple rapid approach for the detection and analysis of drug candidate metabolic profiles. Using MetaboLynx and the built-in chemical intelligence tools allow the scientist to confidently assess compounds and perform complex analyses. Harnessing UPLC/MSE and high resolution bench top instrumentation, such as the Xevo G2 Tof, provides scientists with the tools to carry out relevant studies and generate data to help inform key program decision makers, and drastically reduces turnaround time.
Effect of MS Scan Speed on UPLC Peak Separation and Metabolite Identification: Time of Flight HRMS vs. Orbitrap
Slow MS scan rates can lead to insufficient data points to define a chromatographic peak. This results in the loss of peak resolution, which can lead to false negatives (missed peaks) in metabolite identification studies and significant compromises with the quantitative (or semi-quantitative) assessment of major metabolites.
QTof v. Triple Quad: in vivo Quantitation and Metabolite Identification of Plasma Samples
Advances in sensitivity, detector linear response, and robustness have opened up the possibility for QTof MS platforms to be a viable alternative for use in bioanalysis laboratories. This application note summarizes the results of a quant/qual workflow to determine robustness and reliability of QTof measurements, and compare them against the gold-standard tandem quadrupole workflows.