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Derek L Chappell, Anita Yh Lee, Harold S Bernstein, Michael E Lassman, Omar F Laterza
AIM: Patients with elevated levels of B-type natriuretic peptide (BNP) and/or NT-proBNP as measured by clinical tests have an elevated risk of heart failure (HF). Despite utility in large clinical studies, both assays are plagued by large biological variability and specificity issues. To address these concerns and further investigate BNP in the HF setting, we developed an LC/MS assay to characterize the ratio of active to total BNP. RESULTS: We have developed and validated a novel immunoaffinity LC/MS assay to measure BNP-derived fragments, as well as 'total BNP' in human plasma...
October 7, 2016: Bioanalysis
Zhenhao Qi, Lisu Wang, Aiqing He, Manling Ma-Edmonds, John Cogswell
AIM: Formalin-fixed, paraffin-embedded (FFPE) clinical tissue samples have the potential to provide valuable gene-expression data for the development of cancer biomarkers. However, FFPE RNA is extensively fragmented, presenting a significant challenge for reliably detecting gene expression using traditional qPCR methods. RESULTS: We evaluated three novel methodologies along with the traditional qPCR method for their ability to detect Notch pathway gene expression in colorectal cancer FFPE tissue RNAs...
October 7, 2016: Bioanalysis
Kyra Cowan, Xiaoying Gao, Vaishali Parab, Trung Nguy, Lawren Wu, Joseph R Arron, Michael Townsend, Jeffrey Wallin, Melissa Cheu, Alyssa Morimoto, Eric Wakshull
AIM: To improve on the efficiency of biomarker assay readiness, and for reliable biomarker data to support three drug programs, we implemented a fit-for-purpose approach, qualifying two biomarker assays and validating a third. Results/methodology: The qualification strategy and selection of experiments for two exploratory biomarkers (CXCL1, CCL19) was determined by the intended use of the biomarker data. The third biomarker, IL-6, was validated as the data would be used in monitoring patient safety during dose-escalation studies in a Phase I trial...
October 7, 2016: Bioanalysis
Eric Yang, Jan Welink, Stephanie Cape, Eric Woolf, Jens Sydor, Christopher James, Dina Goykhman, Mark Arnold, Neil Addock, Ronald Bauer, Michael Buonarati, Eugene Ciccimaro, Raj Dodda, Christopher Evans, Fabio Garofolo, Nicola Hughes, Rafiq Islam, Corey Nehls, Amanda Wilson, Chad Briscoe, Mark Bustard, Laura Coppola, Stephanie Croft, Dieter Drexler, Luca Ferrari, Daniela Fraier, Rand Jenkins, John Kadavil, Lloyd King, Wenkui Li, Gustavo Mendes Lima Santos, Adrien Musuku, Ragu Ramanathan, Yoshiro Saito, Natasha Savoie, Scott Summerfield, Rachel Sun, Nilufer Tampal, Steve Vinter, Jason Wakelin-Smith, Qin Yue
The 2016 10(th) Workshop on Recent Issues in Bioanalysis (10(th) WRIB) took place in Orlando, Florida with participation of close to 700 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 including 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 LBA approaches, with the focus on biomarkers and immunogenicity...
October 7, 2016: Bioanalysis
Saloumeh K Fischer, Montserrat Carrasco-Triguero, Kyu Hong, Jeremy Good, Teresa Davancaze, Trung Nguy, Jessica Li, Walter Darbonne, Alyssa Morimoto, Yuda Zhu
AIM: Commercial kits can provide a convenient solution for measuring circulating biomarkers to support drug development. However, their suitability should be assessed in the disease matrix of interest. METHODOLOGY: Twelve biomarkers were evaluated in samples from patients with rheumatoid arthritis. We used immunoassay kits from five vendors on three multiplexed platforms. Kit suitability was evaluated on the basis of detectability and prespecified performance acceptance criteria...
October 5, 2016: Bioanalysis
Richard King, Carmen Fernandez-Metzler, Lorin M Bachmann
No abstract text is available yet for this article.
October 5, 2016: Bioanalysis
Patrick Bennett
No abstract text is available yet for this article.
October 5, 2016: Bioanalysis
Mark E Arnold, Hendrik Neubert, Lauren F Stevenson, Fabio Garofolo
No abstract text is available yet for this article.
November 2016: Bioanalysis
Lauren F Stevenson
No abstract text is available yet for this article.
November 2016: Bioanalysis
Derek Stevenson, Hazim F El-Sharif, Subrayal M Reddy
The accurate determination of intact macromolecules in biological samples, such as blood, plasma, serum, urine, tissue and feces is a challenging problem. The increased interest in macromolecules both as candidate drugs and as biomarkers for diagnostic purposes means that new method development approaches are needed. This review charts developments in the use of molecularly imprinted polymers first for small-molecular-mass compounds then for proteins and other macromolecules. Examples of the development of molecularly imprinted polymers for macromolecules are highlighted...
November 2016: Bioanalysis
Anne-Marie Miller, Aleksandra Rutkowska, Justyna M Bahl, Sanna-Kaisa Herukka, Marleen Ja Koel-Simmelink, Niels Kruse, Brit Mollenhauer, Maritta Siloaho, Anders Skinningsrud, Henrik Zetterberg, Charlotte E Teunissen, Brian A Lawlor
AIM: Neurofilament light (NfL) chain, a putative cerebrospinal fluid biomarker, can support neurodegenerative disease diagnosis and indicate disease severity and prognosis. Universal validation protocols when used to measure biomarkers can reduce pre and analytical laboratory variation, thus increasing end-user confidence in the consistency of validation data across sites. METHODOLOGY: Here, a commercially available NfL ELISA (UmanDiagnostics, UmeƄ, Sweden) was validated in a multicentered setting using comprehensive newly developed standard operating procedures...
November 2016: Bioanalysis
Brian Rago, Tracey Clark, Lindsay King, Jenny Zhang, L Nathan Tumey, Fengping Li, Frank Barletta, Cong Wei, Mauricio Leal, Steve Hansel, Xiaogang Han
AIM: Complex nature of bioconjugates require multiple bioanalytical approaches to support PK and absorption, distribution, metabolism and excretion characterization. For antibody-drug conjugate (ADC) bioanalysis both LC-MS and ligand-binding assays (LBAs) are employed. RESULTS: A method consisting of immunocapture extraction of ADC from biomatrices followed by LC-MS analysis of light and heavy chain is described. Drug antibody ratio (DAR) profiles of ADC Tras-mcVC-PF06380101 dosed at 0...
November 2016: Bioanalysis
Fawzia A Ibrahim, Amira F El-Yazbi, Magda A Barary, Mira M Wagih
AIM: Recently, polytherapy regimen has been introduced for the treatment of epileptic patients for better seizure control with lesser side effects and better control of multiple seizure types. METHODOLOGY: A simple, sensitive and highly specific reversed-phase HPLC method was developed for simultaneous determination of four antiepileptic drugs (AEDs), levetiracetam, lamotrigine, oxcarbazepine and carbamazepine, in real human plasma without interference from endogenous components of plasma...
November 2016: Bioanalysis
Robert MacNeill, Vishva Acharya, Neha Patel, Gregory Parisi, Kim Katto, Robert Lovich
AIM: This work set out to realize an idea for a novel means of extracting the peptide therapeutic bivalirudin from human plasma in what would be a uniquely selective means of SPE, a mixed-mode protocol involving electrostatic interactions followed by HILIC. RESULTS: Inter and intra-assay relative error ranged from 3.52 to 8.23%, and 2.37 to 6.90%, respectively. Inter and intra-assay precision ranged from 2.64 to 7.12%, and 0.855 to 2.90%, respectively. Recoveries of 80% were attained, and there was no hint of discernible manifestation of matrix effects...
November 2016: Bioanalysis
Sajad Azizi, Aziz Shahrisa, Maryam Khoubnasabjafari, Khalil Ansarin, Mehry Khoubnasabjafari, Jafar Soleymani, Abolghasem Jouyban
No abstract text is available yet for this article.
November 2016: Bioanalysis
Suzanne L Parker, Yarmarly C Guerra Valero, Jeffrey Lipman, Jason A Roberts, Steven C Wallis
The reliability of extraction recovery of an analyte in bioanalysis is fundamentally important for downstream analytical testing. For dried format microsamples, if the recovery changes with time the concentration in clinical samples, derived from calibration standards and alongside quality control samples prepared following different drying protocols, may not reflect the true result. The purpose of this paper was therefore to evaluate changes to extraction recovery across time for one analyte, the glycopeptide antibiotic vancomycin, in plasma using two dried microsampling formats, dried plasma spots and volumetric absorptive microsampling...
November 2016: Bioanalysis
Ioanna Athanasiadou, Sven Voss, Emmanouil Lyris, Amina Aljaber, Mohammed Alsayrafi, Costas Georgakopoulos
The 2016 Olympic and Paralympic Games, the biggest event in human sports, was held in Rio de Janeiro with more than 10,500 athletes from 206 countries over the world competing for the highest of sports honors, an Olympic medal. With the hope that the Olympic ideal accompanies all aspects of the XXXI Olympiad, WADA accredited antidoping laboratories use the spearhead of analytical technology as a powerful tool in the fight against doping. This review summarizes the main analytical developments applied in antidoping testing methodology combined with the main amendments on the WADA regulations regarding analytical testing starting from the 2012 London Olympics until the 2016 Olympic Games in Rio de Janeiro...
November 2016: Bioanalysis
Erik C Burns, Jeff Moran, Sheila Breidinger, Stacy Ho, Randy Guthrie, Lakshmi Amaravardi
17th Annual Land O'Lakes Bioanalytical Conference, Madison, WI, USA, 11-14 July 2016 The 17th Annual Land O'Lakes Bioanalytical Conference, titled 'Biomarker Validation, Stability, and Regulatory Concerns', was held on 11-14 July 2016 (Monday through Thursday) in Madison, WI, USA. The Land O'Lakes Conference is presented each year by the Division of Pharmacy Professional Development within the School of Pharmacy at the University of Wisconsin-Madison (USA). The purpose of this 3-day conference is to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices...
November 2016: Bioanalysis
Neil Spooner, Stephanie Cape, Roger Hayes, Surinder Kaur, John Kolman, Stephen Lowes, Scott Summerfield, Amanda Wilson, Eric Woolf
No abstract text is available yet for this article.
November 2016: Bioanalysis
(no author information available yet)
No abstract text is available yet for this article.
November 2016: Bioanalysis
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