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Yi Jiang, Brandon Mistretta, Sarah H Elsea, Qin Sun
AIM: Molybdenum co-factor deficiencies and isolated sulfite oxidase deficiency are rare autosomal recessively inherited diseases characterized by severe psychomotor impairment, intractable seizures, dislocated lens and dysmorphic facial features. The biochemical diagnosis of these diseases requires the determination of urine sulfocysteine. MATERIALS & METHODS: Urine sulfocysteine was quantified by an ultra-high performance liquid chromatography-MS/MS assay. The method was validated for linearity, accuracy, precision, recovery and stability...
May 18, 2018: Bioanalysis
Jefferson Pereira Silva, Mauricio Yonamine
No abstract text is available yet for this article.
May 17, 2018: Bioanalysis
Prashant Tripathi, Harilal Patel, Tanuja Kulshrestha, Nuggehally R Srinivas
No abstract text is available yet for this article.
May 17, 2018: Bioanalysis
Jérôme Vialaret, Sophie Broutin, Célia Pugnier, Sophie Santelé, Aurore Jaffuel, Alan Barnes, Laurent Tiers, Laurent Pelletier, Sylvain Lehmann, Angelo Paci, Christophe Hirtz
AIM: Monoclonal antibody-based treatment of cancer has been established as one of the most successful therapeutic strategies. MATERIALS & METHODS: In this work, we developed a workflow based on an automated protein-A capture and LC-MS/MS analysis to quantify bevacizumab on patient serum during treatment. This analytical approach was fully validated and compared with a commercially available Monoclonal antibody-based treatment preparation (nanosurface and molecular-orientation limited kit)...
May 17, 2018: Bioanalysis
Robert Wilson
AIM: This paper describes the salient points in establishing robustness of the cell-based potency assay, with reference to phase-specific qualification. MATERIALS & METHODS: The methodology was qualified in a thaw for use format utilizing standard parameters. At a later stage, the assay was further developed, and concomitant with requalification the robustness was assessed by fractional factorial design of experiment, the center point data being used for qualification...
May 17, 2018: Bioanalysis
Linda Vårdal, Elisabeth L Øiestad, Astrid Gjelstad, Stig Pedersen-Bjergaard
AIM: Electromembrane extraction (EME) of weakly basic benzodiazepines was investigated (-1.47 < pKa < 5.01). MATERIALS & METHODS: 96-well EME was performed with strongly acidic conditions in the acceptor solution using 250-mM trifluoroacetic acid to maximize ionization. RESULTS & CONCLUSION: Recoveries more than 80% were obtained for analytes with pKa > 2, whereas EME was less efficient for substances with pKa < 2...
May 17, 2018: Bioanalysis
Maria A Simonova, Victor D Pivovarov, Dmitry Y Ryazantsev, Anna S Dolgova, Valentina M Berzhets, Sergei K Zavriev, Elena V Svirshchevskaya
AIM: Estimation of specific IgE is essential for the prevention of allergy progression. Quantitative immuno-PCR (qiPCR) can increase the sensitivity of IgE detection. We aimed to develop qiPCR and compare it to the conventional ELISA in identification of IgE to Alt a 1 and Fel d 1 allergens. RESULTS: Single stranded 60-mer DNA conjugated to streptavidin was used to detect antigen-IgE-biotin complex by qiPCR. In semi-logarithmic scale qiPCR data were linear in a full range of serum dilutions resulting in three- to ten-times higher sensitivity of qiPCR in comparison with ELISA in IgE estimation in low titer sera...
May 17, 2018: Bioanalysis
A David Rodrigues
No abstract text is available yet for this article.
May 16, 2018: Bioanalysis
Donna A Volpe, Praveen V Balimane
No abstract text is available yet for this article.
May 16, 2018: Bioanalysis
Hong Shen
No abstract text is available yet for this article.
May 16, 2018: Bioanalysis
Hamza Kandoussi, Jianing Zeng, Kumar Shah, Patricia Paterson, Rasa Santockyte, Pathanjali Kadiyala, Hong Shen, Petia Shipkova, Robert Langish, Richard Burrrell, John Easter, Thomas Mariannino, Punit Marathe, Yurong Lai, Yan Zhang, Renuka Pillutla
AIM: Coproporphyrins (CP-I and CP-III) have been identified as possible biomarkers to predict human hepatic organic anion-transporting polypeptides-mediated-drug-interactions for a new drug entering clinical development. RESULTS: The method is applicable to quantify plasma CP-I and CP-III within 0.078-15.0 nM. The results identify and address a number of challenges encountered with porphyrin assays such as photodegradation and interferences. To overcome interferences from ubiquitous porphyrins, a surrogate matrix was used to prepare calibration standards...
May 11, 2018: Bioanalysis
Lina Luo, Jared Kay, Jenny Zhang, Christopher L Holliman, A D Rodrigues, Martin Dowty, Christopher Banfield, Ragu Ramanathan
AIM: N1 -methylnicotinamide (1-NMN) has been proposed as a potential clinical biomarker to assess drug-drug interactions involving organic cation transporters (OCT2) and multidrug and toxin extrusion protein transporters. RESULTS: A hydrophilic interaction liquid chromatography-MS/MS assay, to quantify 1-NMN, in human plasma and urine is reported. MATERIALS & METHODS: A hydrophilic interaction chromatography (HILIC)-tandem mass spectrometry (MS/MS) assay to quantify 1-NMN in human plasma and urine is reported...
May 11, 2018: Bioanalysis
Brian Rago, Brendan Tierney, A David Rodrigues, Christopher L Holliman, Ragu Ramanathan
AIM: Selected bile acids (BAs) in plasma have been proposed as endogenous probes for assessing drug-drug interactions involving hepatic drug transporters such as the organic anion-transporting polypeptides (OATP1B1 and OATP1B3). MATERIALS & METHODS: Plasma extracts were analyzed for selected BAs using a triple TOF API6600 high-resolution mass spectrometry. RESULTS: Glycodeoxycholic acid 3-sulfate, glycochenodeoxycholic acid 3-sulfate, glycodeoxycholic acid 3-O-β-glucuronide and glycochenodeoxycholic acid 3-O-β-glucuronide are presented as potential OATP1B1/3 biomarkers...
May 11, 2018: Bioanalysis
Ragu Ramanathan, Anima Ghosal, Lakshmi Ramanathan, Kate Comstock, Helen Shen, Dil Ramanathan
AIM: Evaluation of HPLC-high-resolution mass spectrometry (HPLC-HRMS) full scan with polarity switching for increasing throughput of human in vitro cocktail drug-drug interaction assay. MATERIALS & METHODS: Microsomal incubates were analyzed using a high resolution and high mass accuracy Q-Exactive mass spectrometer to collect integrated qualitative and quantitative (Qual/Quant) data. RESULTS: Within assay, positive-to-negative polarity switching HPLC-HRMS method allowed quantification of eight and two probe compounds in the positive and negative ionization modes, respectively, while monitoring for LOR and its metabolites...
May 11, 2018: Bioanalysis
Amanda King-Ahmad, Sara Clemens, Ragu Ramanathan, Yanhua Zhang, Nancy Raha, Yizhong Zhang, Christopher Holliman, David Rodrigues, Fumin Li
AIM: A validated LC-MS/MS assay for the quantitation of coproporphyrin-I and -III (CP-I, CP-III) in human plasma has been developed to understand the utility of both as possible endogenous biomarkers for organic anion-transporting polypeptides (OATP)-mediated drug-drug interactions (DDIs). MATERIALS AND METHODS:  Human plasma extracts were analyzed for CP-I and CP-III using a 6500+ mass spectrometer. Results: The assay was utilized for plasma samples from a clinical DDI study involving a new chemical entity that presented as an OATP inhibitor in vitro...
May 11, 2018: Bioanalysis
Essam Ezzeldin, Gamal Ae Mostafa, Muzaffar Iqbal, Khalid A Al-Rashood, Yousef Asiri, Toqa El-Nahhas
AIM: Mozavaptan is a nonpeptide vasopressin receptor antagonist approved for the treatment of ectopic antidiuretic hormone secretion syndrome. METHODS & RESULTS: A simple, rapid and fully validated UPLC/MS-MS method was developed for the quantitation of mozavaptan in rat plasma. The chromatographic separation was conducted on an Acquity UPLC BEH™ C18 column with an optimum mobile phase of 10 mM ammonium acetate buffer and 0.1% formic acid in acetonitrile (30:70 v/v) at a flow rate of 0...
May 10, 2018: Bioanalysis
Jia Duo, JoAnne Bruno, Alexander Kozhich, Donata David-Brown, Linlin Luo, Suk Kwok, Rasa Santockyte, Jonathan Haulenbeek, Rong Liu, Lora Hamuro, Jon E Peterson, Steven Piccoli, Binodh DeSilva, Renuka Pillutla, Yan J Zhang
Ligand-binding assay (LBA) performance depends on quality reagents. Strategic reagent screening and characterization is critical to LBA development, optimization and validation. Application of advanced technologies expedites the reagent screening and assay development process. By evaluating surface plasmon resonance technology that offers high-throughput kinetic information, this article aims to provide perspectives on applying the surface plasmon resonance technology to strategic LBA critical reagent screening and characterization supported by a number of case studies from multiple biotherapeutic programs...
April 27, 2018: Bioanalysis
Rafiq Islam, Chad Briscoe, Joseph Bower, Stephanie Cape, Mark Arnold, Roger Hayes, Mark Warren, Shane Karnik, Bruce Stouffer, Yi Qun Xiao, Barry van der Strate, Daniel Sikkema, Xinping Fang, Ariana Tudoroniu, Rabab Tayyem, Ashley Brant, Franklin Spriggs, Colin Barry, Masood Khan, Anahita Keyhani, Jennifer Zimmer, Maria Cruz Caturla, Philippe Couerbe, Ardeshir Khadang, James Bourdage, Jim Datin, Jennifer Zemo, Nicola Hughes, Saadya Fatmi, Curtis Sheldon, Scott Fountain, Christina Satterwhite, Kelly Colletti, Jenifer Vija, Mathilde Yu, John Stamatopoulos, Jenny Lin, Jim Wilfahrt, Andrew Dinan, Susan Ohorodnik, James Hulse, Vimal Patel, Wei Garofolo, Natasha Savoie, Michael Brown, Damon Papac, Mike Buonarati, George Hristopoulos, Chris Beaver, Nadine Boudreau, Clark Williard, Yansheng Liu, Gene Ray, Dominic Warrino, Allan Xu, Rachel Green, Joanne Hayward-Sewell, John Marcelletti, Christina Sanchez, Michael Kennedy, Jessica St Charles, Mohammed Bouhajib, Corey Nehls, Edward Tabler, Jing Tu, Philip Joyce, Adriana Iordachescu, Ira DuBey, John Lindsay, Jim Yamashita, Edward Wells
The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international CRO members offering bioanalytical services were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The second CRO-Pharma Scientific Interchange Meeting was held on 7 April 2017, which included Pharma representatives' sharing perspectives on the topics discussed earlier in the week with the CRO members. The issues discussed at the meetings included cumulative stability evaluations, matrix stability evaluations, the 2016 US FDA Immunogenicity Guidance and recent and unexpected FDA Form 483s on immunogenicity assays, the bioanalytical laboratory's role in writing PK sample collection instructions, biosimilars, CRO perspectives on the use of chiral versus achiral methods, hybrid LBA/LCMS assays, applications of fit-for-purpose validation and, at the Global CRO Council Closed Forum only, the status and trend of current regulated bioanalytical practice in China under CFDA's new BMV policy...
April 27, 2018: Bioanalysis
Muzaffar Iqbal, Essam Ezzeldin, Naser L Rezk, Amal A Bajrai, Khalid A Al-Rashood
AIM: The purpose of this study was development, validation and application of ultra-performance liquid chromatography (UPLC)-ESI-MS/MS method for quantitation of flibanserin in plasma samples. METHOD & RESULTS: After extraction of analyte from plasma by diethyl ether, separation was performed on UPLC C18 column using mobile phase composition of 10 mM ammonium formate-acetonitrile (30:70, v/v) by isocratic elution of 0.3 ml/min. The multiple reaction monitoring transitions of m/z 391...
April 25, 2018: Bioanalysis
Uwe Wessels, Markus Zadak, Astrid Reiser, Janis Brockhaus, Mirko Ritter, Afsaneh Abdolzade-Bavil, Julia Heinrich, Kay Stubenrauch
AIM: High drug concentrations in ocular fluids after intravitreal administration preclude the use of drug-sensitive immunoassays. A drug-tolerant immunoassay is therefore desirable for immunogenicity testing in ophthalmology. EXPERIMENTAL: Immune complex (IC) antidrug antibody (ADA) assays were established for two species. The assays were compared with the bridging assay in ocular and plasma samples from two preclinical studies. RESULTS: The IC assays showed high drug tolerance, which enabled a reliable ADA detection in ocular fluids after intravitreal administration...
April 11, 2018: Bioanalysis
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