Journal of Applied Bioanalysis最新文献

{"title":"Fast analysis of potassium, sodium, calcium, and magnesium cations in total parenteral nutrition formulations with the Wyn-CE Capillary Electrophoresis System coupled with a contactless conductivity detection","authors":"Cédric Sarazin, P. Riollet","doi":"10.17145/JAB.16.010","DOIUrl":"https://doi.org/10.17145/JAB.16.010","url":null,"abstract":"The compounding of Total Parenteral Nutrition (TPN) formulations in hospital pharmacies needs a high quality analytical control due to the risk incurred by the patient [1]. Errors in the electrolyte concentrations can lead to important damages on health patient, especially for babies, in neonatology services. For babies and children, some hospitals used commercial TPN but others preferred Individual Parenteral Nutrition directly prepared in pharmaceutical laboratory manually or with an automated compounding device. An important control of the formulation qualities is today mandatory before the administration to the patient in order to eliminate conception errors which can have serious clinical consequences. Capillary electrophoresis coupled with indirect UV detection was already developed for the analysis of cations in TPN [2] and appeared as a valuable alternative to flame spectrometry or IC. Indirect UV detection for routine analysis can be difficult to implement due to the obligation to create a detection window on the capillary and the use of complex buffers containing most often carcinogen and mutagen chromophore agents. The apparition of contactless conductivity detectors offered to users an easy handling of capillary and a simpler buffer conception. Nussbaumer et al. already presented a CE method dedicated to the problematic of cation in TPN analyses [3]. This method used a hydro-organic Background Electrolyte (BGE) composed by 100 mM Tris/acetate buffer at pH 4.5 and acetonitrile (80/20, v/v). The separation was obtained in 4 min with limits of detection was estimated at 0.02 mM for all cations. This application note focused on the validation of a faster and more sensitive CE method with C4D detection for the JOURNAL OF APPLIED BIOANALYSIS, April 2016, p. 76-80. http://dx.doi.org/10.17145/jab.16.010 (ISSN 2405-710X) Vol. 2, No. 2","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"156 1","pages":"76-80"},"PeriodicalIF":0.0,"publicationDate":"2016-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74151849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ion-pair HPLC method for the quantification of metformin in human urine","authors":"E. Troja, L. Deda, G. Boçari","doi":"10.17145/JAB.16.004","DOIUrl":"https://doi.org/10.17145/JAB.16.004","url":null,"abstract":"Metformin is an oral antidiabetic drug that has been used in the treatment of non-insulin-dependent diabetes, which improves glycemic control by primarily inhibiting hepatic gluconeogenesis and glucogenolysis [1]. Metformin is slowly absorbed after oral administration, about 60% of an oral dose is excreted in the urine as unchanged drug within 24 h, and about 30% of the dose is nonabsorbed and eliminated unchanged in feces [2]. Previous studies have shown a plasma elimination half-life ranging from 2.0 to 6.0 h after oral administration of varying doses (0.5 to 1.5 g/dose) [3]. Urine provides a non-invasive sample collection method, and determination of drug levels in urine is comparatively less complex than plasma and other body fluids [4]. Several reports indicate that urinary excretion data can be used to arrive at bioequivalence decision of different drug formulations [4-6]. Chemically, it is 1,1-dimethyl biguanide (Figure 1). Metformin is a small highly polar molecule (pKa=2.8, 11.5, log P octanol:water= −2.6), which has great solubility in water and poor solubility in lipids; it is also possible to retain in reversed-phase (RP) columns using ion-pairing reagents. Numerous methods for the quantitation of metformin in urine have been utilized over years. They include capillary electrophoresis with contactless conductivity detection [7], voltammetric method [8], cation exchange high-performance liquid chromatography (HPLC) [9], reverse phase RP-HPLC [10-12] and liquid chromatography (LC)–mass spectrometry (MS) [13]. Most of the methods have been based on HPLC with spectrophotometric detection in the range of 230–240 nm (Table 1). Chemical derivatization of metformin has been used JOURNAL OF APPLIED BIOANALYSIS, January 2016, p. 16-24. http://dx.doi.org/10.17145/jab.16.004 (ISSN 2405-710X) Vol. 2, No. 1","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"35 1","pages":"16-24"},"PeriodicalIF":0.0,"publicationDate":"2016-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81056820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bioanalytical evaluation of dried plasma spot microsampling methodologies in pharmacokinetic studies applying Acetaminophen as model drug","authors":"Mayra Parra, J. R. Pabon, R. Meesters","doi":"10.17145/JAB.16.005","DOIUrl":"https://doi.org/10.17145/JAB.16.005","url":null,"abstract":"This paper reports the development and validation of different types of dried plasma spot bioassays and their application in a pharmacokinetic study. The pharmacokinetic study involved a single oral dose of the drug acetaminophen and post-dose blood samples were collected by finger prick. Plasma was separated for dried plasma spot preparation and thereafter quantitatively analyzed by liquid chromatography-accurate mass high resolution mass spectrometry. Comparison of results from bioanalytical performance experiments indicated that the two dried plasma spot bioassays worked well and observed acetaminophen pharmacokinetic values were found not to be statistically significantly different between the evaluated two dried plasma spot bioassays. More over, pharmacokinetic values observed were also not statistically significant different from values reported in literature. Overall, it was concluded that dried plasma spot bioassays could have a great potential as alternative sampling technique in pharmacokinetic studies.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"15 1","pages":"25-37"},"PeriodicalIF":0.0,"publicationDate":"2016-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88329792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In vivo characterization of therapeutic monoclonal antibodies","authors":"Xiaobin Xu","doi":"10.17145/JAB.16.003","DOIUrl":"https://doi.org/10.17145/JAB.16.003","url":null,"abstract":"Therapeutic monoclonal antibodies (mAbs) are complex drug molecules with a high degree of heterogeneity, including charge variants, aggregates, fragments, and post-translational modifications (PTMs). PTMs can be introduced by chemical or enzymatic modifications over the lifespan of mAbs during production, storage, and in vivo circulation. Common PTMs in mAbs include glycosylation, deamidation, oxidation, glycation, N-terminal glutamine cyclization, and C-terminal lysine processing. These product-related modifications are termed as product quality attributes (PQAs). A given PQA has the potential to impact the safety and/or efficacy of a therapeutic mAb. A PQA may enhance immunogenicity or off-target bindings, resulting in changes of the safety profile of a therapeutic mAb. A PQA may change the interaction of a therapeutic mAb to its target antigen, and therefore alter the efficacy. The PQAs that impact on drug safety and/or efficacy are considered as critical quality attributes (CQAs). Control of PQAs, especially CQAs, within predefined acceptance criteria is required by regulatory agencies to ensure product quality, consistency, and stability. During drug development, manufacturing processes aim to maximize the production of a desired product in high purity with minimal and consistent levels of variant forms. Formulation development seeks to stabilize mAb products and minimize additional formation of variants during storage. The modifications occurred during mAb production and storage can be reliably monitored and controlled. However, additional modifications can occur after a mAb is administered to patients. mAbs are typically administered intravenously or subcutaneously, and quickly get into the circulation of patients. The circulating half-life of a typical mAb in human blood system is 2-3 weeks. The blood environment is remarkably different from formulation buffers and storage temperatures. Typical mAb drug products are formulated at a pH of 5-6 with multiple excipients, such as sugars, salts, amino acids, and surfactants. The formulation buffer, pH, and excipients are optimized to enhance mAb solubility/stability and to reduce viscosity as well as the formation of aggregates/particulates. In contrast, blood is a dynamic environment with thousands of proteins including many protein-modifying enzymes, and is tightly regulated at a pH of 7.4 and a temperature of 37 °C. The clearance and modification of a mAb in blood circulation may result in changes of the PQA profile, leading to increased attribute exposure and decreased effective drug exposure to patients, and therefore causing the concerns of immune responses and loss of efficacy. To this end, a recent FDA guidance for industry recommends sponsors to evaluate susceptibilities of therapeutic protein products to modifications in the in vivo milieu as early as in product design and development, in order to facilitate product engineering for enhancing the product stability under in vivo conditi","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"23 1","pages":"10-15"},"PeriodicalIF":0.0,"publicationDate":"2016-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86364648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HSPA-A universal graphical user interface for the Hamilton Microlab STAR liquid handler","authors":"Leimin Fan","doi":"10.17145/JAB.16.006","DOIUrl":"https://doi.org/10.17145/JAB.16.006","url":null,"abstract":"Automated liquid handlers are widely used in sample extraction procedures in bioanalysis. Compared to manual liquid transfer, automated liquid transfer, using a 96-well format, significantly improves efficiency, accuracy, and precision. In addition, automated liquid handlers are evolving constantly through technological advancements in functionality and reliability to address the analytical challenges relevant to Bioanalytical work. The new technology of the Hamilton Microlab STAR liquid handler has unique advantages as a liquid handler desgned to provide the analyst with additional flexibility, such as independent liquid aspiration/dispense in each channel, and untethered access to and from any given location on the machine deck layout.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"5 1","pages":"38-44"},"PeriodicalIF":0.0,"publicationDate":"2016-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86091686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A perspective on the sensitivity of paper-analytical devices for bioanalysis","authors":"Basant Giri","doi":"10.17145/JAB.16.002","DOIUrl":"https://doi.org/10.17145/JAB.16.002","url":null,"abstract":"","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"16 1","pages":"6-9"},"PeriodicalIF":0.0,"publicationDate":"2016-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74166254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Top-down proteomics: applications, recent developments and perspectives","authors":"A. Pamreddy, N. Panyala","doi":"10.17145/JAB.16.009","DOIUrl":"https://doi.org/10.17145/JAB.16.009","url":null,"abstract":"Now-a-days, top-down proteomics (TDP) is a booming approach for the analysis of intact proteins and it is attaining significant interest in the field of protein biology. The term has emerged as an alternative to the well-established, bottom-up strategies for analysis of peptide fragments derived from either enzymatically or chemically digestion of intact proteins. TDP is applied to mass spectrometric analysis of intact large biomolecules that are constituents of protein complexes and assemblies. This article delivers an overview of the methodologies in top-down mass spectrometry, mass spectrometry instrumentation and an extensive review of applications covering the venomics, biomedical research, protein biology including the analysis of protein post-translational modifications (PTMs), protein biophysics, and protein complexes. In addition, limitations of top-down proteomics, challenges and future directions of TDP are also discussed.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"31 1","pages":"52-75"},"PeriodicalIF":0.0,"publicationDate":"2016-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90555131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First anniversary of the Journal of Applied Bioanalysis","authors":"R. Meesters","doi":"10.17145/JAB.16.001","DOIUrl":"https://doi.org/10.17145/JAB.16.001","url":null,"abstract":"","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"70 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2016-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74853790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High throughput analysis at microscale:performance of ionKey/MS with Xevo G2-XS QTof under rapid gradient conditions","authors":"Yun Alelyunas, Gregory T Roman, Jay S. Johnson, C. Doneanu, M. Wrona","doi":"10.17145/JAB.15.021","DOIUrl":"https://doi.org/10.17145/JAB.15.021","url":null,"abstract":"In this paper, high throughput analysis with 3 minute, rapid gradient conditions is described using the ionKey/MS™ System with an integrated ACQUITY UPLC® M-Class System and the Xevo® G2-XS QTof Mass Spectrometer. Extensive testing of representative small molecules and a peptide shows that the system is well-tolerated and exhibits excellent reproducibility and linear response. The iKey™ HSS T3 Separation Device used is robust, withstanding ~2200 injections of prepared human plasma with excellent peak shape and system pressure profile. A 99% solvent savings was realized when compared with an analytical system using a 2.1 mm column with flow rate ranging from 0.6 mL/min to 1.5 mL/min. These data, coupled with examples from the literature, illustrate that the ionKey/MS System with Xevo G2-XS QTof can be used as a full service platform for high throughput analysis and high sensitivity analysis to support all phases of drug discovery and development.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"52 1","pages":"128-135"},"PeriodicalIF":0.0,"publicationDate":"2015-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81379257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimisation of the sensitivity of an immunoassay analysis for tobramycin in serum","authors":"M. Hoppentocht, Onno W Akkeman, A. Voerman, B. Greijdanus, D. Touw, J. Alffenaar","doi":"10.17145/JAB.15.020","DOIUrl":"https://doi.org/10.17145/JAB.15.020","url":null,"abstract":"Tobramycin is an aminoglycoside antimicrobial drug frequently used in anti-pseudomonal therapy in cystic fibrosis and non-cystic fibrosis bronchiectasis patients. Therapeutic drug monitoring is routinely performed to increase efficacy and reduce the chance of toxicity. The most frequently used method to quantify tobramycin in serum or plasma is with an immunoassay method. However, immunoassays lack sensitivity to evaluate the lower concentrations of tobramycin for pharmacokinetic studies of for instance inhaled tobramycin. The aim of this study was to optimise the Syva® Emit® 2000 Tobramycin Assay combined with the ARCHITECT c8000. This adapted method was validated for accuracy and precision, having within-run, between-run variation. The adapted tobramycin immunoassay method has a linear range of 0.03 to 0.6 mg/L, which is comparable to liquid chromatography-mass spectrometry methods. The immunoassay method was validated with representative samples and has been implemented in routine analysis.","PeriodicalId":15014,"journal":{"name":"Journal of Applied Bioanalysis","volume":"12 1","pages":"123-127"},"PeriodicalIF":0.0,"publicationDate":"2015-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87555995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}