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https://www.readbyqxmd.com/read/29236519/supercritical-fluid-chromatography-a-promising-alternative-to-current-bioanalytical-techniques
#1
Amandine Dispas, Hugues Jambo, Sébastien André, Eva Tyteca, Philippe Hubert
During the last years, chemistry was involved in the worldwide effort toward environmental problems leading to the birth of green chemistry. In this context, green analytical tools were developed as modern Supercritical Fluid Chromatography in the field of separative techniques. This chromatographic technique knew resurgence a few years ago, thanks to its high efficiency, fastness and robustness of new generation equipment. These advantages and its easy hyphenation to MS fulfill the requirements of bioanalysis regarding separation capacity and high throughput...
December 13, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29231056/the-application-of-control-charts-in-regulated-bioanalysis-for-monitoring-long-term-reproducibility
#2
Michel van Bruijnsvoort, John Meijer, Cas van den Beld
In regulated bioanalysis, the acceptance of results is batch-wise. When during clinical development derived pharmacokinetic or pharmacodynamic results from different studies will be combined or compared, it is recommendable to monitor the long-term reproducibility of bioanalytical assays. Long-term reproducibility can be evaluated by control charts generated from control samples included in each batch. We present a methodology for the implementation, construction and evaluation of control charts next to the regular batch acceptance of bioanalytical results...
December 2017: Bioanalysis
https://www.readbyqxmd.com/read/29215666/sample-preparation-for-polar-metabolites-in-bioanalysis
#3
Nicolas Drouin, Serge Rudaz, Julie Schappler
Sample preparation is a primary step of any bioanalytical workflow, especially in metabolomics analysis where maximum information has to be obtained without spoiling the analytical instrument. Because of their biological implication, highly polar metabolites, such as amino acids, nucleobases, and catecholamines seem to attract growing interest in the field of comprehensive metabolomics analysis although their extraction from the matrix remains a real challenge. In this paper, we discuss about the actual practice and issues of hydrophilic metabolites' extraction, including new solutions and perspectives to improve their phase transfer from a complex biological sample to a clean extract prior to analysis...
December 7, 2017: Analyst
https://www.readbyqxmd.com/read/29205064/2017-white-paper-on-recent-issues-in-bioanalysis-a-global-perspective-on-immunogenicity-guidelines-biomarker-assay-performance-part-3-lba-immunogenicity-biomarkers-and-pk-assays
#4
Shalini Gupta, Susan Richards, Lakshmi Amaravadi, Steven Piccoli, Binodh Desilva, Renuka Pillutla, Lauren Stevenson, Devangi Mehta, Montserrat Carrasco-Triguero, Robert Neely, Michael Partridge, Roland F Staack, Xuemei Zhao, Boris Gorovits, Gerry Kolaitis, Giane Sumner, Kay-Gunnar Stubenrauch, Linglong Zou, Shashi Amur, Chris Beaver, Isabella Berger, Flora Berisha, Herbert Birnboeck, Joe Bower, Seongeun Julia Cho, Isabelle Cludts, Laurent Cocea, Lorella Di Donato, Saloumeh Fischer, Stephanie Fraser, Fabio Garofolo, Sam Haidar, Jonathan Haulenbeek, Charles Hottenstein, Jenny Hu, Akiko Ishii-Watabe, Rafiq Islam, Darshana Jani, John Kadavil, John Kamerud, Daniel Kramer, Pekka Kurki, Stephen MacMannis, Jim McNally, Ashley Mullan, Apollon Papadimitriou, João Pedras-Vasconcelos, Soma Ray, Afshin Safavi, Yoshiro Saito, Natasha Savoie, Marianne Scheel Fjording, Kara Scheibner, John Smeraglia, An Song, Bruce Stouffer, Nilufer Tampal, Barry van der Strate, Thorsten Verch, Jan Welink, Yuanxin Xu, Tong-Yuan Yang, Lilian Yengi, Jianing Zeng, Yan Zhang, Yanhua Zhang, Stephen Zoog
The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule analysis involving LC-MS, hybrid ligand-binding assay (LBA)/LC-MS and LBA approaches...
December 2017: Bioanalysis
https://www.readbyqxmd.com/read/29205056/ocular-bioanalysis-challenges-and-advancements-in-recent-years-for-these-rare-matrices
#5
Katja Heinig, Enric Bertran, Julian Potter, Daniela Fraier
There are many ocular diseases still presenting unmet medical needs. Therefore, new ophthalmologic drugs are being developed. Bioanalysis of eye compartments (along with plasma and other tissues) is important to determine exposure of the target organ to the drug and to help interpret local pharmacological or toxic effects. This review article identifies several challenges that occur within ocular bioanalysis. They include sample collection and preparation, analytical issues, sourcing control matrix, data interpretation and regulatory requirements...
December 5, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29205053/2017-white-paper-rise-of-hybrid-lba-lcms-immunogenicity-assays-part-2-hybrid-lba-lcms-biotherapeutics-biomarkers-immunogenicity-assays-and-regulatory-agencies-inputs
#6
Hendrik Neubert, An Song, Anita Lee, Cong Wei, Jeff Duggan, Keyang Xu, Eric Woolf, Chris Evans, Joe Palandra, Omar Laterza, Shashi Amur, Isabella Berger, Mark Bustard, Mark Cancilla, Shang-Chiung Chen, Seongeun Julia Cho, Eugene Ciccimaro, Isabelle Cludts, Laurent Cocea, Celia D'Arienzo, Lieza Danan-Leon, Lorella Di Donato, Fabio Garofolo, Sam Haidar, Akiko Ishii-Watabe, Hao Jiang, John Kadavil, Sean Kassim, Pekka Kurki, Olivier Le Blaye, Kai Liu, Rod Mathews, Gustavo Mendes Lima Santos, Makoto Niwa, João Pedras-Vasconcelos, Mark Qian, Brian Rago, Ola Saad, Yoshiro Saito, Natasha Savoie, Dian Su, Matthew Szapacs, Nilufer Tampal, Stephen Vinter, Jian Wang, Jan Welink, Emma Whale, Amanda Wilson, Y-J Xue
The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid ligand binding assay (LBA)/LCMS and LBA approaches...
December 2017: Bioanalysis
https://www.readbyqxmd.com/read/29205052/microspray-and-microflow-liquid-chromatography-the-way-forward-for-lc-ms-bioanalysis
#7
Shane R Needham
No abstract text is available yet for this article.
December 5, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29204581/allergic-fungal-sinusitis-caused-by-schizophyllum-commune
#8
Xiang Liu, Hua Zou, Qiu-Jian Chen, Chang-Ming Lu
A case of allergic fungal sinusitis (AFS) due to Schizophyllum commune was reported. The pathogen was identified using molecular bioanalysis. The patient underwent the functional endoscopic sinus surgery followed by the radical maxillary sinusotomy with canine fossa trephine. This case suggested that complete surgery allowed optimal disease clearance for AFS caused by Schizophyllum commune.
March 2017: World Journal of Otorhinolaryngology—Head and Neck Surgery
https://www.readbyqxmd.com/read/29201591/optofluidic-bioanalysis-fundamentals-and-applications
#9
Damla Ozcelik, Hong Cai, Kaelyn D Leake, Aaron R Hawkins, Holger Schmidt
Over the past decade, optofluidics has established itself as a new and dynamic research field for exciting developments at the interface of photonics, microfluidics, and the life sciences. The strong desire for developing miniaturized bioanalytic devices and instruments, in particular, has led to novel and powerful approaches to integrating optical elements and biological fluids on the same chip-scale system. Here, we review the state-of-the-art in optofluidic research with emphasis on applications in bioanalysis and a focus on waveguide-based approaches that represent the most advanced level of integration between optics and fluidics...
July 2017: Nanophotonics
https://www.readbyqxmd.com/read/29196830/a-multi-site-in-depth-evaluation-of-the-quanterix-simoa-from-a-user-s-perspective
#10
Allison Given Chunyk, Alison Joyce, Saloumeh K Fischer, Mark Dysinger, Alvydas Mikulskis, Andreas Jeromin, Rosemary Lawrence-Henderson, Dana Baker, David Yeung
An in-depth evaluation of the Quanterix© Simoa™ platform was undertaken by scientists from the AAPS Emerging Technologies Focus Group to determine the overall performance of the technology as well as provide guidance to future users. In order to test the platform in a non-GLP bioanalytical setting, a cross-site evaluation of the Quanterix IL-6 biomarker kit was performed. Parameters tested during this evaluation included sensitivity, accuracy and precision, and parallelism in human serum from normal individuals...
December 1, 2017: AAPS Journal
https://www.readbyqxmd.com/read/29194932/paper-based-polymer-electrodes-for-bioanalysis-and-electrochemistry-of-neurotransmitters
#11
Raphaël Trouillon, Martin Gijs
This article describes the preparation and characterization of PEDOT-coated paper electrodes. Their specific behavior was investigated, especially the impact of electrode shape on the electrochemical properties. It was found that different electrode geometries promote different results, largely because of a potential drop in the bulk of the electrode material. More importantly, the suitability of these substrates for bio- and neurochemical analyses was investigated. The paper electrodes were found to offer better resistance to both protein and neurotransmitter foulings, in comparison to a planar electrode...
November 30, 2017: Chemphyschem: a European Journal of Chemical Physics and Physical Chemistry
https://www.readbyqxmd.com/read/29171771/icp-ms-determination-of-serum-aluminum-in-monkeys-subcutaneously-administered-an-alhydrogel-formulated-drug-candidate
#12
Wenkui Li, Jiawei Gong, Chuan Wang, Zhongping John Lin, Jimmy Flarakos
AIM: To develop and validate an inductively coupled plasma-mass spectrometry method for quantitative bioanalysis of aluminum (Al) in monkey serum in support of a GLP TOX study with alhydrogel-formulated drug candidate. METHODS & RESULTS: The method was linear over a dynamic range of 10-1000 ng/ml using a 50-μl sample volume. The intra-/inter-run precision (%CV) of the quality control sample results were ≤7.9% (CV) and the accuracy (%bias) within ±11.0% across all quality control concentrations evaluated...
November 24, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29171758/toward-best-practices-in-data-processing-and-analysis-for-intact-biotherapeutics-by-ms-in-quantitative-bioanalysis
#13
John F Kellie, Jonathan R Kehler, Molly Z Karlinsey, Scott G Summerfield
AIM: Typically, quantitation of biotherapeutics from biological matrices by LC-MS is based on a surrogate peptide approach to determine molecule concentration. Recent efforts have focused on quantitation of the intact protein molecules or larger mass subunits of monoclonal antibodies. To date, there has been limited guidance for large or intact protein mass quantitation for quantitative bioanalysis. METHODOLOGY: Intact- and subunit-level analyses of biotherapeutics from biological matrices are performed at 12-25 kDa mass range with quantitation data presented...
November 24, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29164851/an-integrated-redox-cycling-for-electrochemical-enzymatic-signal-enhancement
#14
Md Rajibul Akanda, Huangxian Ju
Highly sensitive analytical methods for the detection of proteins are still an urgent demand in early medical diagnosis and discovery of biomarkers with ultralow abundance. Here an integrated electrochemical-chemical-enzymatic redox cycling is designed for significant enhancement of electrochemical enzymatic signal in biorecognition. This strategy efficiently utilizes the high specificity of outer-sphere to inner-sphere redox reaction to mediate the enzymatic redox cycling with the nonenzymatic redox cycling...
November 22, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/29154197/investigation-of-the-effect-of-blood-hematocrit-and-lipid-content-on-the-blood-volume-deposited-by-a-disposable-dried-blood-spot-collection-device
#15
N Spooner, A Olatunji, K Webbley
When using dried blood spot (DBS) sampling for the quantitative bioanalysis of circulating concentrations of drugs, metabolites and endogenous analytes, it is important that a fixed volume of blood is deposited to overcome the issues associated with blood hematocrit (HCT) and homogeneity. The volumetric performance of the KTH DBS collection device was tested with radiolabelled [(14)C]-diclofenac. It was demonstrated that the device deposits a fixed volume of blood (13.5μL) regardless of the HCT (25-65%), or lipid content of the blood sample...
November 14, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29149235/isolated-complexes-of-the-amino-acid-arginine-with-polyether-and-polyamine-macrocycles-the-role-of-proton-transfer
#16
Juan Ramón Avilés-Moreno, Giel Berden, Jos Oomens, Bruno Martínez-Haya
The distinct basicity of the guanidinium side-group of arginine (Arg) sustains specific interactions involved in essential biochemical processes. The sensing of arginine is therefore key in modern biotechnology and bioanalysis. In this context, the development of molecular receptors based on crown ether building blocks has demonstrated great potential. We investigate the complexes formed by arginine with two benchmark macrocycles, 12-crown-4 (1,4,7,10-tetraoxacyclododecane) and its N-substituted analog cyclen (1,4,7,10-tetraazacyclododecane)...
November 17, 2017: Physical Chemistry Chemical Physics: PCCP
https://www.readbyqxmd.com/read/29148835/2017-white-paper-on-recent-issues-in-bioanalysis-aren-t-bmv-guidance-guidelines-scientific-part-1-lcms-small-molecules-peptides-and-small-molecule-biomarkers
#17
Jan Welink, Eric Yang, Nicola Hughes, Brian Rago, Eric Woolf, Jens Sydor, Laura Coppola, Brad Ackermann, Wenkui Li, Stephen C Alley, Mark Arnold, Isabella Berger, Chad Briscoe, Michael Buonarati, Mark Bustard, Mark Cancilla, Seongeun Julia Cho, Jeff Duggan, Daniela Fraier, Fabio Garofolo, Rachel Green, Sam Haidar, Lucinda Hittle, Akiko Ishii-Watabe, Rafiq Islam, Rand Jenkins, Barry Jones, John Kadavil, Sean Kassim, Olga Kavetska, Olivier Le Blaye, Anita Lee, Hanlan Liu, John Mehl, Gustavo Mendes Lima Santos, Adrien Musuku, Ragu Ramanathan, Yoshiro Saito, Natasha Savoie, Scott Summerfield, Sekhar Surapaneni, Matthew Szapacs, Nilufer Tampal, Tom Verhaeghe, Stephen Vinter, Emma Whale
The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis, Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS and ligand-binding assay (LBA) approaches...
November 17, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29135236/photoelectrochemical-immunoassays
#18
Wei-Wei Zhao, Jing-Juan Xu, Hong-Yuan Chen
No abstract text is available yet for this article.
November 21, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/29128290/antibody-drug-quantitation-in-coexistence-with-anti-drug-antibodies-on-nsmol-bioanalysis
#19
Noriko Iwamoto, Akinobu Hamada, Takashi Shimada
Therapeutic monoclonal antibodies (mAbs) are developed for treatment of diverse cancers and autoimmune diseases. For expansion of mAbs approval against unapproved diseases and pharmaceutical development, pharmacokinetics study is very important. Bioanalysis provides one of the most essential index against pharmacokinetics information. So far, we developed useful method for bioanalysis of mAbs in plasma or serum, nSMOL: nano-surface and molecular-orientation limited proteolysis. This method can provide accurate and reproducible value of mAbs content in plasma...
November 9, 2017: Analytical Biochemistry
https://www.readbyqxmd.com/read/29120238/incurred-sample-reanalysis-adjusted-procedure-for-sample-size-calculation
#20
Piotr J Rudzki, Katarzyna Buś-Kwaśnik, Michał Kaza
AIM: The incurred sample reanalysis (ISR) helps to assure bioanalysis reliability. The regulatory guidelines recommend the reanalysis of up to 10% of the study samples for this test, but not all reanalyses are necessary to evaluate the test result. MATERIALS & METHODS: We have optimized ISR sample size calculation to eliminate negligible reanalyses. RESULTS: Adjusted procedure eliminates negligible reanalyses - up to 66% of currently analyzed ISRs - without affecting the test outcome...
November 2017: Bioanalysis
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