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Bioanalysis

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https://www.readbyqxmd.com/read/29451404/optimizing-nbe-pk-pd-assays-using-the-gyrolab-affinity-software-conveniently-within-the-bioanalyst-s-existing-workflow
#1
Maria Myzithras, Tammy Bigwarfe, Erica Waltz, Hua Li, Jennifer Ahlberg, Irina Rybina, Sarah Low, Cynthia Hess Kenny, John Miglietta, Rachel Kroe-Barrett
AIM: The fully automated microfluidics-based Gyrolab is a popular instrument for the bioanalysis of protein therapeutics; requiring minimal sample and reagent volumes. Gyros offers affinity software for determining binding affinity in solution using a high-throughput method and miniaturized reactions. RESULTS: Using this affinity software, multiple CTGF-targeting reagents were characterized on the Gyrolab after <100% target coverage was seen in a cynomolgus pharmacokinetic/PD study dosed with anti-CTGF antibodies...
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29451398/examining-heat-treatment-for-stabilization-of-the-lipidome
#2
Jeremy P Koelmel, Christina M Jones, Candice Z Ulmer, Timothy J Garrett, Richard A Yost, Tracey B Schock, John A Bowden
AIM: To confidently determine lipid-based biomarkers, it is important to minimize variation introduced during preanalytical steps. We evaluated reducing variation associated with lipid measurements in invertebrate sentinel species using a state-of-the-art heat treatment technique. MATERIALS AND METHODS: Earthworms (Eisenia fetida), house crickets (Acheta domestica) and ghost shrimp (Palaemonetes paludosus) were euthanized either by flash freezing or heat treatment...
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29451394/clinical-application-of-microsampling-versus-conventional-sampling-techniques-in-the-quantitative-bioanalysis-of-antibiotics-a-systematic-review
#3
Yarmarly C Guerra Valero, Steven C Wallis, Jeffrey Lipman, Christophe Stove, Jason A Roberts, Suzanne L Parker
Conventional sampling techniques for clinical pharmacokinetic studies often require the removal of large blood volumes from patients. This can result in a physiological or emotional burden, particularly for neonates or pediatric patients. Antibiotic pharmacokinetic studies are typically performed on healthy adults or general ward patients. These may not account for alterations to a patient's pathophysiology and can lead to suboptimal treatment. Microsampling offers an important opportunity for clinical pharmacokinetic studies in vulnerable patient populations, where smaller sample volumes can be collected...
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29451392/evaluation-of-cams-for-14-c-microtracer-adme-studies-opportunities-to-change-the-current-drug-development-paradigm
#4
Frédéric Lozac'h, Simon Fahrni, Daniele De Maria, Caroline Welte, Joël Bourquin, Hans-Arno Synal, David Pearson, Markus Walles, Gian Camenisch
AIM: Although regulatory guidances require human metabolism information of drug candidates early in the development process, the human mass balance study (or hADME study), is performed relatively late. hADME studies typically involve the administration of a 14 C-radiolabelled drug where biological samples are measured by conventional scintillation counting analysis. Another approach is the administration of therapeutic doses containing a 14 C-microtracer followed by accelerator mass spectrometry (AMS) analysis, enabling hADME studies completion much earlier...
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29451391/the-future-of-lc-ms-for-pharmaceutical-analysis-an-interview-with-jun-qu
#5
Jun Qu
Jun Qu speaks to Sankeetha Nadarajah, Editor of Bioanalysis: Jun Qu is the group leader of the proteomics and pharmaceutical analysis lab of SUNY-Buffalo (NY, USA) and a Professor in the Department of Pharmaceutical Sciences. His research is focused on the study of Clinical and Pharmaceutical Proteomics and Pharmaceutical Analysis using LC-MS-based strategies. His research programs include high-resolution and large-scale expression profiling of pathological proteomes, for the discovery of novel disease/therapeutics biomarkers using gel-free proteomic methods; sensitive identification, localization and quantification of post-translational modifications in tissue proteomes such as these in myocardium, using novel anti-PTM affinity capture and alternating Collision-induced dissociation/Electron transfer dissociation to obtain abundant PTM information; targeted investigation of marker proteins that are of high interests for clinical and pharmaceutical study, using highly sensitive nano-LC/SRM-based methods; and highly sensitive and accurate investigation of the PK of biotherapeutics using LC-MS...
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29451018/incorporating-dried-blood-spot-lc-ms-ms-analysis-for-clinical-development-of-a-novel-oncolytic-agent
#6
Enaksha R Wickremsinhe, Sophie Callies, Chris A Schmalz, Lisa B Lee, Elizabeth S LaBell, Darlene K Satonin
AIM: Design and execution of a dried blood spot (DBS-LC-MS/MS) assay for pharmacokinetic analyses in oncology patients. RESULTS & DISCUSSION: The methodology was validated to collect and store DBS samples from multiple clinical sites, and analyze blood with diverse hematocrit ranges (25-55) to match the potential patient population. Bridging data comparing DBS and plasma showed high degree of concordance with DBS:plasma ratios of 0.81, demonstrating no preferential uptake or association with cellular components of the blood...
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29451011/lc-ms-n-small-molecule-drug-analysis-in-human-serum-could-adducts-have-good-prospects-for-therapeutic-applications
#7
Marek Dziadosz
No abstract text is available yet for this article.
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29451001/parallel-artificial-liquid-membrane-extraction-of-psychoactive-analytes-a-novel-approach-in-therapeutic-drug-monitoring
#8
Katharina Norgren Olsen, Kristine Skoglund Ask, Stig Pedersen-Bjergaard, Astrid Gjelstad
AIM: Liquid-liquid extraction is widely used in therapeutic drug monitoring of antipsychotics, but difficulties in automation of the technique can result in long operational time. In this paper, parallel artificial liquid membrane extraction was used for extraction of serotonin- and serotonin-norepinephrine reuptake inhibitors from human plasma, and an approach to automate the technique was investigated. RESULTS: Eight model analytes were extracted from 125 μl human plasma with recoveries in the range 72-111% (relative standard deviation [RSD] ≤12...
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29451000/novel-automated-immune-turbidimetric-assay-for-routine-urinary-cystatin-c-determinations
#9
Balázs Szirmay, Péter Kustán, Zoltán Horváth-Szalai, Andrea Ludány, Ágnes Lakatos, Diána Mühl, István Wittmann, Attila Miseta, Gábor L Kovács, Tamás Kőszegi
AIM: There is no commercially available urinary cystatin-C (u-CYSC) test in the market. Therefore, we optimized and validated an automated immune turbidimetric test for u-CYSC measurements and investigated u-CYSC concentrations in acute and chronic diseases which might lead to renal tubular disorders. MATERIALS & METHODS: A particle-enhanced immune turbidimetric assay was adapted and validated on a Cobas 8000/c502 analyzer. Urine samples of different patient groups were also analyzed...
February 16, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29376744/coated-blade-spray-shifting-the-paradigm-of-direct-sample-introduction-to-ms
#10
Germán Augusto Gómez-Ríos, Marcos Tascon, Janusz Pawliszyn
Coated blade spray (CBS) is a solid-phase microextraction-based technology that can be directly coupled to MS to enable the rapid qualitative and quantitative analysis of complex matrices. The goal of this mini review is to concisely introduce CBS's operational fundamentals and to consider how it correlates/contrasts with existing direct-to-MS technologies suitable for bioanalytical applications. In addition, we provide a fair comparison of CBS to other existing solid-phase microextraction-to-MS approaches, as well as an overview of recent CBS applications/strategies that have been developed to analyze diverse compounds present in biofluids...
January 29, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29345521/development-and-validation-of-an-elisa-to-study-panitumumab-pharmacokinetics
#11
Céline Desvignes, Christophe Passot, David Ternant, Morgane Caulet, Caroline Guérineau, Thierry Lecomte, Gilles Paintaud
AIM: Panitumumab is a monoclonal antibody directed against EGFR that is approved for the treatment of metastatic colorectal cancer. To investigate its pharmacokinetics and concentration-response relationship, a validated assay is required. RESULTS: An ELISA assay was developed and validated according to international recommendations. Six calibrators (ranging from 0.1 to 20 mg/l) plus one anchor point (50 mg/l) and three quality controls (0.45, 2 and 8 mg/l) were defined...
January 18, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29345502/extended-3d-and-4d-cumulative-plots-for-evaluation-of-unmatched-incurred-sample-reanalysis
#12
Piotr J Rudzki, Michał Kaza, Przemysław Biecek
AIM: Incurred sample reanalysis (ISR) helps ensure the reliability of pharmacokinetic studies. An appropriate graph may facilitate the evaluation of an unmatched reanalyses or a failed ISR test. METHODS: We evaluated different ways of visualizing multidimensional ISR data using an extended cumulative ISR plot. RESULTS: 3D and 4D cumulative ISR plots enable comprehensive data analysis using a single plot. We propose to use color for percentage difference classes in bar and XY-scatter plots...
January 18, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29345496/feedback-from-the-european-bioanalysis-forum-focus-workshop-on-current-analysis-of-immunogenicity-best-practices-and-regulatory-hurdles
#13
Joanne Goodman, Simon Cowen, Viswanath Devanarayan, David Egging, Thomas Emrich, Michaela Golob, Daniel Kramer, Jim McNally, James Munday, Robert Nelson, João A Pedras-Vasconcelos, Timo Piironen, Denise Sickert, Venke Skibeli, Marianne Scheel Fjording, Philip Timmerman
European Bioanalysis Forum Workshop, Lisbon, Spain, September 2016: At the recent European Bioanalysis Forum Focus Workshop, 'current analysis of immunogenicity: best practices and regulatory hurdles', several important challenges facing the bioanalytical community in relation to immunogenicity assays were discussed through a mixture of presentations and panel sessions. The main areas of focus were the evolving regulatory landscape, challenges of assay interferences from either drug or target, cut-point setting and whether alternative assays can be used to replace neutralizing antibody assays...
January 18, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29345151/emerging-technologies-for-biotherapeutic-bioanalysis-from-a-high-throughput-and-multiplexing-perspective-insights-from-an-aaps-emerging-technology-action-program-committee
#14
Shobha Purushothama, Mark Dysinger, Yao Chen, Karolina Österlund, Johanna Mora, Allison Given Chunyk, Russ Peloquin
This manuscript aims to provide insights and updates on emerging technologies from a throughput and multiplexing perspective and to update readers on changes in previously reported technologies. The technologies discussed range from nascent (ultrasensitive Cira, Intellicyt®, Dynaxi and Captsure™) to the more established (Ella and SQIDlite™). For the nascent technologies, there was an emphasis on user interviews and reviews, where available, to help provide an unbiased view to our readers. For the Ella, a review of published user data as well as author and other user experiences are summarized...
January 18, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29333875/ultrafast-determination-of-vitamin-e-using-lc-esi-ms-ms-for-preclinical-development-of-new-nutraceutical-formulations
#15
Noemi Villaseca-González, Virginia Rodríguez Robledo, Lucía Castro-Vázquez, María Victoria Lozano, Manuel J Santander-Ortega, Joaquín González-Fuentes, Pilar Marcos, María Del Mar Arroyo-Jiménez
AIM: We proposed a rapid and high quality method to determine α-tocopherol (α-T) in different biopharmaceutical samples using liquid chromatography-diode array detector on-line ESI-MS/MS. MATERIALS & METHODS: A working standard solution of α-T and internal standard, phenyl-5,7-dimethyl-d6-α-tocopherol, were used for optimization and validation of the method. Levels of α-T in nanoemulsions, serum and plasma samples were evaluated. RESULTS & CONCLUSION: Precision (1% for retention time, 5% for peak area and 3% for relative peak area), linearity range (among 0...
January 15, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29333871/drug-monitoring-by-volumetric-absorptive-microsampling-method-development-considerations-to-mitigate-hematocrit-effects
#16
Kasie Fang, Chester L Bowen, John Kellie, Molly Karlinsey, Christopher Evans
AIM: GSKA is a compound that was in development in clinical trials. A bioanalysis method to quantify GSKA using volumetric absorptive microsampling (VAMS) was developed and hematocrit (HCT) related assay bias was investigated. METHODOLOGY: After accurate sampling of 10 μl blood, VAMS tips were air dried approximately 18 h and desorbed by an aqueous solution containing internal standard. The recovered blood underwent liquid-liquid extraction in ethyl acetate to minimize matrix suppression...
January 15, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29333869/quantitation-of-saxitoxin-in-human-urine-using-immunocapture-extraction-and-lc-ms
#17
William A Bragg, Alaine Garrett, Elizabeth I Hamelin, Rebecca M Coleman, Katrina Campbell, Christopher T Elliott, Rudolph C Johnson
AIM: An immunomagnetic capture protocol for use with LC-MS was developed for the quantitation of saxitoxin (STX) in human urine. MATERIALS & METHODS: This method uses monoclonal antibodies coupled to magnetic beads. STX was certified reference material grade from National Research Council, Canada. Analysis was carried out using LC-MS. RESULTS: With an extraction efficiency of 80%, accuracy and precision of 93.0-100.2% and 5.3-12.6%, respectively, and a dynamic range of 1...
January 15, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29333868/drug-detection-in-biological-specimens-recent-colorimetric-methods
#18
Samin Hamidi
No abstract text is available yet for this article.
January 15, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29333866/offline-derivatization-lc-ms-ms-method-for-simultaneous-estimation-of-vanillin-and-vanillic-acid-in-guinea-pig-plasma
#19
Priyadeep Bhutani, Senthilkumar Murugesan, Anoop Kumar, Murali Subramanian, Koiram Rajanna Prabhakar
AIM: Vanillin used as a positive control substrate of aldehyde oxidase activity gets metabolized to vanillic acid. Low MW and low sensitivity in negative ion mode are challenges with these analytes. Our objective was to develop a simple offline derivatization LC-MS/MS method to address these challenges. METHODOLOGY/RESULTS: A simple dansyl chloride derivatization of the phenolic groups on vanillin and vanillic acid was adopted to enable easy ionization in commonly used acidic mobile phases...
January 15, 2018: Bioanalysis
https://www.readbyqxmd.com/read/29333863/principles-of-vaccine-potency-assays
#20
Thorsten Verch, Jeremiah J Trausch, Mary Shank-Retzlaff
Compared with biologics, vaccine potency assays represent a special challenge due to their unique compositions, multivalency, long life cycles and global distribution. Historically, vaccines were released using in vivo potency assays requiring immunization of dozens of animals. Modern vaccines use a variety of newer analytical tools including biochemical, cell-based and immunochemical methods to measure potency. The choice of analytics largely depends on the mechanism of action and ability to ensure lot-to-lot consistency...
January 15, 2018: Bioanalysis
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