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    2187 results match your criteria Bioanalysis [Journal]

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    Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments.
    Bioanalysis 2017 Sep 18. Epub 2017 Sep 18.
    Biologics Development Sciences, Janssen BioTherapeutics, Janssen R&D, LLC, 1400 McKean Road, PO Box 776, Spring House, PA 19477, USA.
    Bioanalytical methods must enable the delivery of data that meet sound, scientifically justified, fit-for-purpose criteria. At early phases of biotherapeutic drug development, suitable criteria of a ligand-binding assay could be met for pharmacokinetic (PK) in-study sample testing without a full validation defined by regulatory guidelines. To ensure fit-for-purpose methods support PK testing through all phases of biotherapeutic development, three tiers of method validation - regulatory, scientific and research validations - are proposed. Read More

    Investigation of O-glycosylation heterogeneity of recombinant coagulation factor IX using LC-MS/MS.
    Bioanalysis 2017 Sep 18. Epub 2017 Sep 18.
    Asia Glycomics Reference Site, Daejeon, Korea.
    Aim: Recombinant coagulation factor IX (rFIX) has extraordinarily multiple post-translational modifications including N-glycosylation and O-glycosylation which have a drastic effect on biological functions and in vivo recovery. Unlike N-glycosylation extensively characterized, there are a few studies on O-glycosylation due to its intrinsic complexity. In-depth O-glycosylation analysis is necessary to better understand and assess pharmacological activity of rFIX. Read More

    Sensitive and comprehensive analysis of O-glycosylation in biotherapeutics: a case study of novel erythropoiesis stimulating protein.
    Bioanalysis 2017 Sep 18. Epub 2017 Sep 18.
    Asia Glycomics Reference Site, Chungnam National University, Daejeon, Korea.
    Aim: Glycosylation of recombinant human erythropoietins (rhEPOs) is significantly associated with drug's quality and potency. Thus, comprehensive characterization of glycosylation is vital to assess the biotherapeutic quality and establish the equivalency of biosimilar rhEPOs. However, current glycan analysis mainly focuses on the N-glycans due to the absence of analytical tools to liberate O-glycans with high sensitivity. Read More

    Challenges and opportunities in bioanalytical support for gene therapy medicinal product development.
    Bioanalysis 2017 Sep 18. Epub 2017 Sep 18.
    Bioanalytical Sciences, Bristol-Myers Squibb, Lawrenceville, NJ 08543, USA.
    Gene and nucleic acid therapies have demonstrated patient benefits to address unmet medical needs. Beside considerations regarding the biological nature of the gene therapy, the quality of bioanalytical methods plays an important role in ensuring the success of these novel therapies. Inconsistent approaches among bioanalytical labs during preclinical and clinical phases have been observed. Read More

    Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.
    Bioanalysis 2017 Sep 18. Epub 2017 Sep 18.
    Fresenius-Kabi (SwissBiosim), Z.I. de l'Ouriettaz, 1170 Aubonne, Switzerland.
    Biosimilar drug development has brought new challenges to bioanalytical ligand-binding assays used to determine drug concentration, antidrug antibodies and neutralizing antibodies. One particular challenge is how to demonstrate that the antidrug antibody assay can adequately detect antibodies against both biosimilar and originator. In this paper, we review the current guidelines and literature for practical recommendations and present a gap analysis. Read More

    LC-MS determination of fentanyl in human serum and application to a fentanyl transdermal delivery pharmacokinetic study.
    Bioanalysis 2017 Sep 15. Epub 2017 Sep 15.
    Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
    Aim: Fentanyl is an opioid agonist used for acute and chronic pain management. In this report, a highly sensitive and simple LC-MS/MS method using Hydrophilic Interaction Chromatography (HILIC) column was validated and used for fentanyl quantification in human serum.

    Results: The isocratic mobile phase was composed of acetonitrile: 10 mM ammonium formate buffer (pH = 3. Read More

    Evaluation of an FcRn affinity chromatographic method for IgG1-type antibodies and evaluation of IgG variants.
    Bioanalysis 2017 Sep 13. Epub 2017 Sep 13.
    Pharma Technical Development Analytics Biologics, F. Hoffmann-La Roche Ltd, 4070 Basel, Switzerland.
    Aim: The neonatal Fc-receptor (FcRn) mediates long serum half-life of therapeutic IgG-type antibodies. This interaction represents a critical quality attribute in terms of pharmacokinetics and should be covered by respective quality control strategies. Antibodies are taken up by cells unspecifically and can bind to FcRn in early endosomes preventing lysosomal degradation and allowing release back into circulation. Read More

    Comparative study on microsampling techniques in metabolic fingerprinting studies applying gas chromatography-MS analysis.
    Bioanalysis 2017 Sep 13. Epub 2017 Sep 13.
    Department of Chemistry, Grupo de Investigación en Química Analítica y Bioanalítica (GABIO), Universidad de los Andes, Cra. 1 No. 18ª-10, Bogotá D.C., Colombia.
    Aim: Sample collection and preparation are important steps in the metabolomics workflow. Any improvement should be aimed toward making them simpler, faster and more reproducible. This paper describes the evaluation of different types of whole blood microsampling techniques applied in a metabolic fingerprinting study of breast cancer patients. Read More

    LC-MS/MS analysis of lipidized analogs of prolactin-releasing peptide utilizing a monolithic column and simple sample preparation.
    Bioanalysis 2017 Sep 13. Epub 2017 Sep 13.
    Department of Biochemistry and Molecular Biology, Institute of Organic Chemistry & Biochemistry AS CR, Flemingovo náměstí 2, 16610 Prague, Czech Republic.
    Aim: Novel compounds for obesity treatment are currently being studied employing lipidized analogs of anorexigenic neuropeptides. Various analogs of prolactin-releasing peptide have demonstrated their ability to decrease food intake. Adequate analytical tools are required to support corresponding research. Read More

    Development of a plug and play ImmunoPCR technique for the analysis of biomolecules.
    Bioanalysis 2017 Sep 13. Epub 2017 Sep 13.
    Global Biomarker Discovery & Development, Biogen Inc, Cambridge, MA 02142, USA.
    Aim: ImmunoPCR technology combines the advantages of specificity and robustness of a ligand binding assay with the amplification potential of PCR. We describe through three case studies a plug-and-play immuno polymerase chain reaction (iPCR) technique to measure biomolecules.

    Results: Case Study 1 demonstrated feasibility of measurement of IgG1 in cerebrospinal fluid at the desired level of sensitivity with minimal cost and timelines of clinical assay implementation. Read More

    Outsourcing in bioanalysis: a CRO perspective.
    Bioanalysis 2017 Aug;9(15):1161-1164
    Bioanalytical & ADME Laboratories, Q2 Solutions, 19 Brown Road, Ithaca, NY 14850, USA.
    Steve Lowes from Q(2) Solutions speaks to Sankeetha Nadarajah, Managing Commissioning Editor: about outsourcing strategy implementation. Steve started his industrial career at VG Biotech in the UK that became the LC-MS instrument entity of Waters Corporation. Since joining the CRO group that became Advion and then Q(2) Solutions, his career has focused on regulated bioanalysis with particular emphasis on LC-MS. Read More

    Post-acquisition data mining techniques for LC-MS/MS-acquired data in drug metabolite identification.
    Bioanalysis 2017 Aug 17;9(16):1265-1278. Epub 2017 Aug 17.
    National Institute of Pharmaceutical Education & Research - Ahmedabad, Opposite Air force Station, Palaj, Gandhinagar-382355, Gujarat, India.
    Metabolite identification is a crucial part of the drug discovery process. LC-MS/MS-based metabolite identification has gained widespread use, but the data acquired by the LC-MS/MS instrument is complex, and thus the interpretation of data becomes troublesome. Fortunately, advancements in data mining techniques have simplified the process of data interpretation with improved mass accuracy and provide a potentially selective, sensitive, accurate and comprehensive way for metabolite identification. Read More

    Development and validation of an enzyme-linked immunosorbent assay to measure free eculizumab concentration in serum.
    Bioanalysis 2017 Aug 2;9(16):1227-1235. Epub 2017 Aug 2.
    Université François Rabelais de Tours, CNRS UMR 7292 GICC, Tours, France.
    Aim: Eculizumab is a monoclonal antibody toward C5 fraction of the complement system. It is approved to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. To perform pharmacokinetic studies and therapeutic drug monitoring, a validated assay is required. Read More

    Overcoming disease-specific matrix effect in a clinical pharmacokinetic assay using a microfluidic immunoassay technology.
    Bioanalysis 2017 Aug 2;9(16):1207-1216. Epub 2017 Aug 2.
    Assay Development & Technology, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
    Aim: Etrolizumab, a humanized monoclonal antibody, has demonstrated clinical remission in a Phase II study of ulcerative colitis patients. In the Phase III program, a second indication, Crohn's disease was added. The pharmacokinetic ELISA used in the Phase I/II studies in normal human and ulcerative colitis sera exhibited matrix interference in the Crohn's disease population, necessitating implementation of a new technology. Read More

    A comparison study of bioanalytical methods for characterization of anti-idursulfase antibodies.
    Bioanalysis 2017 Aug 2;9(16):1237-1246. Epub 2017 Aug 2.
    Bioanalytical & Biomarker Development, Shire, Lexington, MA 02421 USA.
    Aim: Legacy methods with complex testing scheme for characterization of anti-idursulfase antibodies (ADA) were simplified and optimized in order to meet current regulatory guidance and provide more timely and cost-effective support for routine patient care.

    Results: To compare the performance of the original and updated methods, patient samples receiving commercially prescribed Elaprase treatment were analyzed by both test methods. The ADA and neutralizing antibody results obtained by both methods were highly correlated and the updated method had an overall higher ADA and neutralizing antibody positive rates and higher ADA titers. Read More

    Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum.
    Bioanalysis 2017 Aug 2;9(16):1253-1264. Epub 2017 Aug 2.
    Novo Nordisk A/S, Måløv, Denmark.
    Flow cytometry is a powerful tool that can be used for the support of (pre)clinical studies. Although various white papers are available that describe the set-up and validation of the instrumentation (the flow cytometer) and validation of flow cytometry methods, to date no guidelines exist that address the requirements for performing flow cytometry in a regulated environment. In this manuscript, the European Bioanalysis Forum presents additional practice guidance on the use of flow cytometry in the support of drug development programs and addresses areas that are not covered in the previous publications. Read More

    Changing shape: evolving an outsourced bioanalytical strategy to support the changing needs of drug development.
    Bioanalysis 2017 Aug 1;9(15):1135-1137. Epub 2017 Aug 1.
    Translational Biomarkers & Bioanalysis, Drug Safety & Metabolism, IMED, AstraZeneca, Fleming Building (B623), Babraham Research Campus, C/O Darwin Building 310, Milton Science Park, Cambridge, CB4 OWG, UK.

    Outsourcing bioanalytical services at Janssen Research and Development: the sequel anno 2017.
    Bioanalysis 2017 Aug 1;9(15):1195-1201. Epub 2017 Aug 1.
    Development Bioanalysis, Janssen R&D, Turnhoutseweg 30, 2340 Beerse, Belgium.
    The strategy of outsourcing bioanalytical services at Janssen has been evolving over the last years and an update will be given on the recent changes in our processes. In 2016, all internal GLP-related activities were phased out and this decision lead to the re-orientation of the in-house bioanalytical activities. As a consequence, in-depth experience with the validated bioanalytical assays for new drug candidates is currently gained together with the external partner, since development and validation of the assay and execution of GLP preclinical studies are now transferred to the CRO. Read More

    AstraZeneca and Covance Laboratories Clinical Bioanalysis Alliance: an evolutionary outsourcing model.
    Bioanalysis 2017 Aug 1;9(15):1181-1194. Epub 2017 Aug 1.
    Bioanalytical Services, Covance Laboratory Services, Harrogate, HG3 1PY, UK.
    The AstraZeneca and Covance Laboratories Clinical Bioanalysis Alliance (CBioA) was launched in 2011 after a period of global economic recession. In this challenging environment, AstraZeneca elected to move to a full and centralized outsourcing model that could optimize the number of people supporting bioanalytical work and reduce the analytical cost. This paper describes the key aspects of CBioA, the innovative operational model implemented, and our ways of ensuring this was much more than simply a cost reduction exercise. Read More

    Workshop on Recent Issues in Bioanalysis (WRIB) Poster Award winners 2017.
    Bioanalysis 2017 Jul;9(14):1065-1068
    Ablynx NV, Zwijnaarde, Belgium.
    The 11th WRIB held in Los Angeles, CA, USA in April 2017. It drew over 750 professionals representing large Pharmas, Biotechs, CROs and multiple regulatory agencies from around the world, from the global bioanalytical community. Bioanalysis and Bioanalysis Zone are very proud to be supporting the WRIB Poster Awards again this year, and we feature the profiles of the authors of the winning posters. Read More

    Preclinical pharmacokinetics and biodistribution studies of asenapine maleate using novel and sensitive RP-HPLC method.
    Bioanalysis 2017 Jul 24;9(14):1037-1047. Epub 2017 Jul 24.
    Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, Karnataka State, India.
    Aim: Asenapine maleate (ASPM) is a newer antipsychotic drug available as a sublingual tablet in the market.

    Experimental: To investigate the pharmacokinetic and tissue distribution study of ASPM following oral administration in rats, reversed-phase HPLC method was developed and validated.

    Results: ASPM was extracted from plasma and tissue matrix by liquid-liquid extraction technique and analyzed using mobile phase consisted of phosphate buffer pH 3. Read More

    Parallelism experiments to evaluate matrix effects, selectivity and sensitivity in ligand-binding assay method development: pros and cons.
    Bioanalysis 2017 Jul 24;9(14):1107-1122. Epub 2017 Jul 24.
    Biomarker Services, PPD Laboratories, 2244 Dabney Road, Richmond, VA 23230, USA.
    Parallelism is an essential experiment characterizing relative accuracy for a ligand-binding assay (LBA). By assessing the effects of dilution on the quantitation of endogenous analyte(s) in matrix, selectivity, matrix effects, minimum required dilution, endogenous levels of healthy and diseased populations and the LLOQ are assessed in a single experiment. This review compares and discusses all available approaches that can be used to assess key assay parameters for pharmacokinetic and biomarker LBAs, as well as the advantages and disadvantages of each approach. Read More

    Chromatographic determination of zonisamide, topiramate and sulpiride in plasma by a fluorescent 'turn-on' chemosensor.
    Bioanalysis 2017 Jul 24;9(14):1049-1064. Epub 2017 Jul 24.
    Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Alexandria University, Alexandria 21521, Egypt.
    Aim: Antiepileptics (AEDs) and antipsychotics are often coprescribed. Interactions between these drugs may affect both efficacy and toxicity. Therefore, drug monitoring is necessary for appropriate dosage adjustments. Read More

    Mass spectrometric techniques for the analysis of volatile organic compounds emitted from bacteria.
    Bioanalysis 2017 Jul 24;9(14):1069-1092. Epub 2017 Jul 24.
    Department of Environmental Chemistry & Bioanalytics, Faculty of Chemistry, Interdisciplinary Centre of Modern Technologies, Nicolaus Copernicus University, 7 Gagarina Str., 87-100 Torun, Poland.
    Bacteria are the main cause of many human diseases. Typical bacterial identification methods, for example culture-based, serological and genetic methods, are time-consuming, delaying the potential for an early and accurate diagnosis and the appropriate subsequent treatment. Nevertheless, there is a stringent need for in situ tests that are rapid, noninvasive and sensitive, which will greatly facilitate timely treatment of the patients. Read More

    Matrix effect management in liquid chromatography mass spectrometry: the internal standard normalized matrix effect.
    Bioanalysis 2017 Jul 24;9(14):1093-1105. Epub 2017 Jul 24.
    Laboratory of Clinical Pharmacology & Pharmacogenetics, Unit of Infectious Diseases, Department of Medical Sciences, 'Amedeo di Savoia' Hospital, University of Turin, 10149 Turin, Italy.
    LC-MS is becoming a standard for many applications, thanks to high sensitivity and selectivity; nevertheless, some issues are still present, particularly due to matrix effect (ME). Considering this, the use of optimal internal standards (ISs, usually stable-isotope labeled) is important, but not always possible because of cost or availability. Therefore, a deep investigation of the inter-lot variability of the ME and of the correcting power of the chosen IS (isotope-labeled or not) is mandatory. Read More


    Improving the sensitivity and specificity of a bioanalytical assay for the measurement of certolizumab pegol.
    Bioanalysis 2017 Aug 14;9(16):1217-1226. Epub 2017 Jul 14.
    UCB Pharma, Department of Bioanalytical Sciences, Slough, UK.
    Aim: In order to evaluate placental transfer of certolizumab pegol (CZP), a more sensitive and selective bioanalytical assay was required to accurately measure low CZP concentrations in infant and umbilical cord blood. Results & methodology: A new electrochemiluminescence immunoassay was developed to measure CZP levels in human plasma. Validation experiments demonstrated improved selectivity (no matrix interference observed) and a detection range of 0. Read More

    The validation of an LC-MS/MS assay for perhexiline and major hydroxy metabolites, and its application to therapeutic monitoring in patient plasma.
    Bioanalysis 2017 Jul 10;9(13):1011-1025. Epub 2017 Jul 10.
    Medpace, Inc., 5375 Medpace Way, Cincinnati, OH 45227 USA.
    Aim: Perhexiline (PEX), being developed to treat hypertrophic cardiomyopathy, is toxic at levels above the therapeutic range. Plasma level monitoring is therefore essential. The absence of a UV-absorbing chromophore has in the past required quantitative analysis of PEX in plasma using lengthy derivatization methods, followed by HPLC and fluorescence detection. Read More

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