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Eginhard Schick, Roland F Staack, Markus Haak, Gregor Jordan, Uwe Dahl, Julia Heinrich, Herbert Birnboeck, Apollon Papadimitriou
AIM: Active drug assays are becoming increasingly important in protein drug development. We describe the validation of a ligand-binding assay for active protein drug quantification and address practical challenges as well as regulatory implications. RESULTS: A bioanalytical method for active protein drug quantification was successfully validated. Validation data prove that this method can be routinely used applying the commonly accepted acceptance criteria for ligand-binding assays...
November 3, 2016: Bioanalysis
Yongliang Sun, Katherine Yang, Terry Bridal, Anka G Ehrhardt
AIM: Ki67 is a prognostic and/or predictive biomarker in patients with malignancies. Flow cytometry is a powerful technology for single-cell multiparameter analysis. RESULTS: We developed and validated a multicolor quantitative flow cytometry assay for detection of intracellular Ki67 expression in various immune cell subsets from human blood. The assay was optimized and showed excellent precisions. Assessment of the sample stability indicated that percentage changes from the fresh sample for the reportable results of interest were within 20%, up to 72 h after blood collection in the Cyto-Chex(®) BCT tube...
November 3, 2016: Bioanalysis
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
Raúl González-Domínguez, Ana Sayago, Ángeles Fernández-Recamales
Metabolomics based on direct mass spectrometry (MS) analysis, either by direct infusion or flow injection of crude sample extracts, shows a great potential for metabolic fingerprinting because of its high-throughput screening capability, wide metabolite coverage and reduced time of analysis. Considering that numerous metabolic pathways are significantly perturbed during the initiation and progression of diseases, these metabolomic tools can be used to get a deeper understanding about disease pathogenesis and discover potential biomarkers for early diagnosis...
January 2017: Bioanalysis
Georgios Moros, Anastasia Chrysovalantou Chatziioannou, Helen G Gika, Nikolaos Raikos, Georgios Theodoridis
AIM: Metabolomics applications represent an emerging field where significant efforts are directed. Derivatization consists prerequisite for GC-MS metabolomics analysis. METHODS: Common silylation agents were tested for the derivatization of blood plasma. Optimization of methoxyamination and silylation reactions was performed on a mixture of reference standards, consisting of 46 different metabolites. Stability of derivatized metabolites was tested at 4°C. RESULTS: Optimum results were achieved using N-methyl-N-(trimethylsilyl)trifluoroacetamide...
January 2017: Bioanalysis
C Virgiliou, L Valianou, M Witting, F Moritz, C Fotakis, P Zoumpoulakis, A C Chatziioannou, L Lazaros, G Makrydimas, K Chatzimeletiou, N Raikos, G A Theodoridis
AIM: Till now there is very limited knowledge on the molecular content of coelomic fluid and cells. This study presents the first attempt to elucidate the metabolic profile of such samples. METHODOLOGY: Samples were collected via coelocentesis from 41 women during the first trimester of gestation. Metabolic content was assessed using four different analytical platforms. For targeted analysis a hydrophilic interaction chromatography ultra high performance LC-MS/MS method was applied...
January 2017: Bioanalysis
Olga Deda, Helen Gika, Theodoros Panagoulis, Ioannis Taitzoglou, Nikolaos Raikos, Georgios Theodoridis
AIM: Physical exercise can reduce adverse conditions during aging, while both exercise and aging act as metabolism modifiers. The present study investigates rat fecal and cecal metabolome alterations derived from exercise during rats' lifespan. METHODS & RESULTS: Groups of rats trained life-long or for a specific period of time were under study. The training protocol consisted of swimming, 15-18 min per day, 3-5 days per week, with load of 4-0% of rat's weight. Fecal samples and cecal extracts were analyzed by targeted and untargeted metabolic profiling methods (GC-MS and LC-MS/MS)...
January 2017: Bioanalysis
Antonia García, Joanna Godzien, Ángeles López-Gonzálvez, Coral Barbas
Highly polar and ionic metabolites, such as sugars, most amino acids, organic acids or nucleotides are not retained by conventional reversed-phase LC columns and polar stationary phases and hydrophilic-interaction LC lacks of robustness, which is still limiting their applications for untargeted metabolomics where reproducibility is a must. Biological samples such as blood, urine or even tissues include many hydrophilic compounds secreted from cells, their analysis is essential for biomarker discovery, disease progression or treatment effects...
January 2017: Bioanalysis
Hiroaki Takeda, Yoshihiro Izumi, Atsumi Tomita, Tomonari Koike, Masashi Shiomi, Eiichiro Fukusaki, Fumio Matsuda, Takeshi Bamba
AIM: Abnormal lipid metabolism results in the alteration of lipid compositions in lipoproteins; therefore an accurate and quantitative analytical approach is required for the detailed structural characterization of lipoproteins. However, the specific lipid composition of each lipoprotein particle is poorly understood. MATERIALS & METHODS: Lipid composition of very-low-density lipoprotein and low-density lipoprotein particles derived from myocardial infarction-prone rabbits was determined by normalization of lipidomics data using apoB-100 levels...
January 2017: Bioanalysis
Ian Wilson
No abstract text is available yet for this article.
January 2017: Bioanalysis
Thomas O Metz, Erin S Baker, Emma L Schymanski, Ryan S Renslow, Dennis G Thomas, Tim J Causon, Ian K Webb, Stephan Hann, Richard D Smith, Justin G Teeguarden
Measuring the exposome remains a challenge due to the range and number of anthropogenic molecules that are encountered in our daily lives, as well as the complex systemic responses to these exposures. One option for improving the coverage, dynamic range and throughput of measurements is to incorporate ion mobility spectrometry (IMS) into current MS-based analytical methods. The implementation of IMS in exposomics studies will lead to more frequent observations of previously undetected chemicals and metabolites...
January 2017: Bioanalysis
Udi Jumhawan, Toshiyuki Yamashita, Kazuya Ishida, Eiichiro Fukusaki, Takeshi Bamba
AIM: There is urgent need to develop a new protocol for the evaluation of chemical substances to potentially interact with the endocrine system and induce numerous pathological issues. The recently validated in vitro screening assay is limited on monitoring two steroid hormones. Methodology & results: The H295R model cell was exposed to seven endocrine disrupting chemicals (EDCs). The levels of 17 steroid hormones in cell extracts were subsequently determined by a quantitative targeted GC/MS/MS method...
January 2017: Bioanalysis
Adam P Rosebrock
No abstract text is available yet for this article.
January 2017: Bioanalysis
Stefan Kiesgen, Armin Schröder, Thomas Schwarz, Oliver Czupalla, Manuela Braun, Mark Jean Gnoth, Joanna Grudzinska-Goebel
Determination of concentration-time profiles in cynomolgus monkeys of a therapeutic monoclonal antibody against a soluble target revealed a substantial discrepancy between a generic anti-human IgG capture/detection and target bridging assay with the target bridging assay leading to dose- and time-dependent underquantification of drug concentrations, lack of parallelism and subsequently different pharmacokinetic parameters. In contrast, plasma levels derived from a target capture and an anti-idiotypic antibody bridging assay were in close concordance with the generic assay and demonstrated parallelism with high precision across several dilutions...
December 2016: Bioanalysis
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