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A device for dried blood microsampling in quantitative bioanalysis: overcoming the issues associated blood hematocrit

Neil Spooner, Philip Denniff, Luc Michielsen, Ronald De Vries, Qin C Ji, Mark E Arnold, Karen Woods, Eric J Woolf, Yang Xu, Valérie Boutet, Patricia Zane, Stuart Kushon& James B Rudg Abstract Aims: A cross-laboratory experiment has been performed on a novel dried blood sampler in order to investigate whether it overcomes issues associated with blood volume and hematocrit (HCT) that are observed when taking a subpunch from […]

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Nano-LC in proteomics: recent advances and approaches

Steven Ray Wilson, Tore Vehus, Henriette Sjaanes Berg& Elsa Lundanes Abstract In proteomics, nano-LC is arguably the most common tool for separating peptides/proteins prior to MS. The main advantage of nano-LC is enhanced sensitivity, as compounds enter the MS in more concentrated bands. This is particularly relevant for determining low abundant compounds in limited samples. Nano-LC columns can

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Flow cytometry: principles, applications and recent advances

Sonal M Manohar , Prachi Shah & Anusree Nair Abstract Flow cytometry (FCM) is a sophisticated technique that works on the principle of light scattering and fluorescence emission by the specific fluorescent probe-labeled cells as they pass through a laser beam. It offers several unique advantages as it allows fast, relatively quantitative, multiparametric analysis of cell populations at the

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Hemato-critical issues in quantitative analysis of dried blood spots: challenges and solutions

Pieter MM De Kesel‡, Nele Sadones‡, Sara Capiau‡, Willy E Lambert& Christophe P Stove Abstract Dried blood spot (DBS) sampling for quantitative determination of drugs in blood has entered the bioanalytical arena at a fast pace during the last decade, primarily owing to progress in analytical instrumentation. Despite the many advantages associated with this new sampling strategy, several issues

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The importance of experimental design and QC samples in large-scale and MS-driven untargeted metabolomic studies of humans

Warwick B Dunn, Ian D Wilson, Andrew W Nicholls& David Broadhurst Abstract The metabolic investigation of the human population is becoming increasingly important in the study of health and disease. The phenotypic variation can be investigated through the application of metabolomics; to provide a statistically robust investigation, the study of hundreds to thousands of individuals is required. In

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Microfluidic 3D cell culture: potential application for tissue-based bioassays

XiuJun (James) Li, Alejandra V Valadez, Peng Zuo& Zhihong Nie Abstract Current fundamental investigations of human biology and the development of therapeutic drugs commonly rely on 2D monolayer cell culture systems. However, 2D cell culture systems do not accurately recapitulate the structure, function or physiology of living tissues, nor the highly complex and dynamic 3D environments in vivo. Microfluidic

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Matrix effects and application of matrix effect factor

Wanlong Zhou, Shuang Yang& Perry G Wang Although, LC–MS is one of the most sensitive and selective analytical techniques, it often suffers from matrix effects, especially when using ESI for analyzing extracts of complicated matrices [1–3]. Matrix effects are often caused by the alteration of ionization efficiency of target analytes in the presence of co-eluting compounds in the

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Analytical techniques for metabolomic studies: a review

Karen Segers, Sven Declerck, Debby Mangelings, Yvan Vander Heyden& Ann Van Eeckhaut Abstract Metabolomics is the comprehensive study of small-molecule metabolites. Obtaining a wide coverage of the metabolome is challenging because of the broad range of physicochemical properties of the small molecules. To study the compounds of interest spectroscopic (NMR), spectrometric (MS) and separation techniques (LC, GC, supercritical fluid

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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)

Luying Pan†, Johanna Mora†, Karl Walravens†, Leslie Wagner†, Shirley Hopper†, Lina Loo†, David Bettoun†, Sarah Bond†, Francis Dessy†, Sean Downing†, Fabio Garofo, Soumi Gupta†, Neil Henderson†, Chad Irwin†, Akiko Ishii-Watabe†§, Sumit Kar†§, Vibha Jawa†, Julie Joseph†, Ludovic Malvaux Abstract The 2022 16th Workshop on Recent Issues in Bioanalysis (WRIB) took place in Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively

2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach) Read More »

2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)

Lina Loo†, Shannon Harris†Mark Milton†, Meena†, Wibke Lembke†, Flora Berisha†, Sylvie Bertholet†, Francis Dessy†, Robert Dodge†, Xiaodong Fang†, Michele Fiscella†, Fabio Garofolo†, Boris Gorovits†, Soumi Gupta†, Vibha Jawa†, Akiko Ishii-Watabe†, Brian Long†, Yanmei Lu†, Timothy Mack†, Kristina McGuire†, Katrina Nola Abstract The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly

2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization) Read More »

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