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Brian P Booth, Brian Furmanski
No abstract text is available yet for this article.
July 11, 2018: Bioanalysis
Jeffrey X Duggan
No abstract text is available yet for this article.
July 11, 2018: Bioanalysis
Bertrand Rochat
Today, many LC-high-resolution MS instruments have become affordable, easy-to-use, sensitive and quantitative. Meanwhile, there is an increased need for more comprehensive approaches. However, omics analyses are still restricted to specialists whereas, in hospitals, routine analyses are targeted and quantitative and represent the main and heavy tasks. But the availability of fully automated LC-MS instruments that can handle independently from sample extraction to result reporting, as well as the increasing biomedical interest for global approaches, clinical analytical workflow should be reorganized...
July 10, 2018: Bioanalysis
Robert Hofstetter, Georg M Fassauer, Andreas Link
'Automated supercritical fluid extraction-supercritical fluid chromatography is an innovative method with low-effort sampling strategies (e.g., dried blood spots) that may make large-scale application faster, cheaper and greener than currently thought possible'.
July 10, 2018: Bioanalysis
Dan Zhang, Changyong Yang, Xiaoyan Chen, Xiuli Li, Dafang Zhong
AIM: SHR-1222 is a humanized monoclonal antibody targeted to soluble sclerostin. To support the preclinical study of SHR-1222 in cynomolgus monkeys, a method for the detection of anti-drug antibodies is required. RESULTS: A bridging immunogenicity method for the detection of anti-SHR-1222 antibodies was developed and validated. In the method, minimal required dilution, normalization factor and confirmatory cut point were 1:20, 4.35 and 10.45%, respectively. The method was successfully applied to evaluate a multiple-dose toxicity study in monkeys...
July 10, 2018: Bioanalysis
Raúl González-Domínguez
No abstract text is available yet for this article.
July 10, 2018: Bioanalysis
Xi Qiu, Lijuan Kang, Martin Case, Naidong Weng, Wenying Jian
AIM: Sample extraction using immuno-affinity capture coupled with LC-high-resolution mass spectrometer has recently emerged as a novel approach for the determination of concentrations of large molecules at intact level in biological matrix. METHODOLOGY: In the current work, different data processing strategies for intact protein bioanalysis, deconvoluted mass spectra or extracted ion chromatogram, were applied to quantitate monoclonal antibody in biological samples for comparison of assay performance...
July 4, 2018: Bioanalysis
Filip K Sucharski, Simon Meier, Christian Miess, Morty Razavi, Matt Pope, Richard Yip, N Leigh Anderson, Terry W Pearson, Andrew Paul Warren, Carsten Krantz
AIM: Hybrid LC-MS/MS assays are increasingly used to quantitate proteins in biological matrices. These assays involve analyte enrichment at the protein level. Although suitability has been demonstrated, they are limited by the lack of appropriate affinity reagents and may suffer from interferences caused by binding proteins or antibodies. RESULTS: An online stable isotope standards and capture by anti-peptide antibodies assay was developed, which involves tryptic digestion of a therapeutic monoclonal antibody in human serum to destroy interfering proteins followed by enrichment using high affinity peptide antibodies...
July 4, 2018: Bioanalysis
Yue Zhao, Huidong Gu, Naiyu Zheng, Jianing Zeng
In recent years, immunocapture enrichment coupled with LC-MS technology has seen more applications for the measurement of low abundant protein therapeutics and biomarkers in biological matrices. In this article, several critical considerations for the application of immunocapture enrichment to LC-MS bioanalysis of protein therapeutics and biomarkers, including reagent selection, reagent characterization, designing of capture format, etc. are discussed. All these considerations are critical in developing reliable and robust bioanalytical assays with high assay specificity and sensitivity...
July 4, 2018: Bioanalysis
Kjetil Hansen, Szabolcs Szarka, Emilie Escoffier, Amandine Berthet, Joris Venet, Justine Collet-Brose, Sophie Hepburn, Michael Wright, Robert Wheller, Robert Nelson, Richard G Kay
AIM: LC-MS/MS bottom-up quantitation of proteins has become increasingly popular with trypsin as the most commonly used protease. However, trypsin does not always yield suitable surrogate peptides. An alternative enzyme, Glu-C, was used to generate surrogate peptides for quantifying a bispecific IgG1 biotherapeutic antibody in preclinical matrices.  Materials and methods: IgG1 was quantified by pellet digestion using an Acquity UPLC coupled  with a Xevo TQ-S mass spectrometer.  Results: Two generic LC-MS/MS methods (heavy and light chain) were developed which afforded acceptable precision and accuracy, and an lower limit of quantitation of 1 μg/ml in three preclinical matrices...
July 4, 2018: Bioanalysis
Jie Pu, Bo An, Faye Vazvaei, Jun Qu
No abstract text is available yet for this article.
July 4, 2018: Bioanalysis
Liyun Zhang, Lisa A Vasicek, SuChun Hsieh, Shuli Zhang, Kevin P Bateman, Jack Henion
AIM: The requirements for developing antibody biotherapeutics benefit from understanding the nature and relevant aspects of the entire molecule. The method presented herein employs on-line multidimensional LC-quadrupole time-of-flight (QTOF)-MS for the quantitative determination of an antibody isolated from biological samples while maintaining the intact native biologically active conformation of the antibody. RESULTS: Following method optimization for a model antibody, an incurred biotherapeutic in cynomologus monkey was quantified in its intact top-down native conformation...
June 28, 2018: Bioanalysis
Peter Bults, Marcel Meints, Anders Sonesson, Magnus Knutsson, Rainer Bischoff, Nico C van de Merbel
AIM: Protein quantitation by digestion of a biological sample followed by LC-MS analysis of a signature peptide can be a challenge because of the high complexity of the digested matrix. Results/methodology: The use of LC with high-resolution (quadrupole-TOF) MS detection allowed quantitation of the 22-kDa biopharmaceutical somatropin in 60 μl of rat plasma down to 25 ng/ml with minimal further sample treatment. Reducing the mass extraction window to 0.01 Da considerably decreased the interference of tryptic peptides, enhanced sensitivity and improved accuracy and precision...
June 28, 2018: Bioanalysis
Weifeng Xu, Jennifer Cummings, Michael Sank, Marina Juhel, Xuefeng Li, Carol Gleason, Binodh S DeSilva, Robert W Dodge, Renuka Pillutla
Ipilimumab is the first US FDA-approved immune checkpoint-blocking antibody drug to harness the patient's own immune cells. One of the postmarketing requirements is to develop a cell-based neutralizing antibody assay. Here, we share some of the most challenging aspects encountered during the assay development: new cell line construction; an unexpected inhibition of T-cell activation by low concentrations of ipilimumab; and two issues caused by sample pretreatment with acid dissociation to overcome drug interference: instability of neutralizing antibody positive control at low pH, and incompatibility of commonly used acid dissociation buffers in the cell assay...
June 27, 2018: Bioanalysis
Mark E Arnold
No abstract text is available yet for this article.
June 20, 2018: Bioanalysis
Robert J Neely
Biomarker ligand-binding assays need to be validated for use on clinical studies in the drug development process. There is not one single guidance to cover all types of biomarker assays and their intended uses. Therefore, it is up to the scientist to piece together a validation strategy based on published papers and other sources. Shown here is a summary of what to take into consideration during a validation and how to apply it for use in the drug development process.
June 20, 2018: Bioanalysis
John L Allinson
Biomarker assays have brought significant challenges to bioanalytical laboratories that historically have provided pharmacokinetic analytical services to the drug development industry. This has largely been due to two reasons: the lack of regulatory guidance in how to validate biomarker assays and the lack of scientists in bioanalytical laboratories with experience in this clinical arena. Since biomarkers have been measured for many decades in clinical laboratories globally, this article reviews the different types of analytical laboratories and their practices and case studies will demonstrate the potential outcomes of using biomarker assays in drug development when they are not validated correctly...
June 20, 2018: Bioanalysis
Laura M Yee, Tracy G Lively, Lisa M McShane
Biomarkers are frequently being included in early phase clinical trials. This article is meant to introduce clinical investigators to the fundamentals of choosing a biomarker test for use in an early phase trial. Steps to consider are briefly outlined including defining the role of the biomarker in the early phase trial; selecting a fit-for-purpose biomarker test and laboratory; describing the test procedures; carrying out analytical validation testing appropriate for the research objectives and the risk involved in the trial; implementing the test in the trial; and planning for the future...
June 20, 2018: Bioanalysis
Zhuqiu Ye, Jing Tu, Krishna Midde, Mike Edwards, Patrick Bennett
No abstract text is available yet for this article.
June 20, 2018: Bioanalysis
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