Abstract：
:Despite significant analytical improvements during this last decade, characterizing the whole integrity of monoclonal antibodies during their bioproduction remains a challenge. In this study, we report a new analytical approach to evaluate the overall heterogeneity/integrity of mAbs by LC-MS after combined proteolysis at their lower- and upper-hinge sites using the immunoglobulin-degrading enzymes IdeS and IgdE respectively. The whole sample preparation did not use any harsh conditions such as low pH, high temperature or reductive conditions and enables the splitting of mAbs structure into three fragments, namely the hinge dimer, Fab and Fc/2. Using the NIST mAb reference material, this method was demonstrated to be particularly suited for the analysis of mAbs disulfide bridges. The three fragments as well as their corresponding free sulfhydryl forms were well separated by chromatography and identified online by mass spectrometry. The method was then successfully applied to several mAbs of variable hydrophobicities.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Faid V,Leblanc Y,Bihoreau N,Chevreux Gdoi
10.1016/j.jpba.2017.11.046subject
Has Abstractpub_date
2018-02-05 00:00:00pages
541-546eissn
0731-7085issn
1873-264Xpii
S0731-7085(17)31977-5journal_volume
149pub_type
杂志文章abstract：:Molecularly imprinted polymers (MIPs) for caffeic acid (CA) were prepared using 4-vinylpyridine and methacrylamide (MAM) as functional monomers, divinylbenzene as a crosslinker and acetonitrile-toluene (3:1, v/v) as a porogen by precipitation polymerization. The use of MAM as the co-monomer resulted in the formation o...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.12.052
更新日期：2016-08-05 00:00:00
abstract：:Recently it was found that normal adults excrete pipecolic acid primarily as the D-enantiomer even though it is present in the blood stream mainly as the L-enantiomer (i.e. > 98% L). This study of pipecolic acid stereochemistry was extended to subjects with peroxisomal deficiencies since they are known to have high le...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(93)80044-2
更新日期：1993-10-01 00:00:00
abstract：:In the present study, an accurate and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the determination of plasma talazoparib concentration in rats was developed and established. The purpose of chromatographic separation of talazoparib and the internal standard (bosut...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.112850
更新日期：2020-01-05 00:00:00
abstract：:A sensitive quantitative liquid chromatography-tandem mass spectrometry assay for afatinib in rat plasma was developed and validated using afatinib dimaleate as a standard. The analyte was determined to be ionized using the positive ion multiple reaction monitoring mode through electrospraying on an AB Sciex Triple Qu...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.10.043
更新日期：2019-02-05 00:00:00
abstract：:In this paper, the thermal stability of pure l-thyroxine (THY) and l-thyroxine sodium salt hydrate (THYSS) vs. two pharmaceutical solid formulations commercialized on both Romanian and European market (with a content of 100μg, respectively 200μg THYSS per tablet) were investigated. In order to determine whether the pr...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.03.026
更新日期：2016-06-05 00:00:00
abstract：:This review paper discusses the success of columns packed with superficially porous particles (SPP) in liquid chromatography for the analysis of peptides and proteins. First, it summarizes the history of SPP, including the development of different SPP generations from particles of 50 μm to sub-2 μm. It also critically...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2018.06.006
更新日期：2018-09-05 00:00:00
abstract：:A high-performance liquid chromatographic method for the determination of lomefloxacin in human plasma has been developed and validated. A solid-phase extraction procedure was used to isolate lomefloxacin from the biological matrix prior to the quantitative analysis. The compound was separated on a Vydac anion-exchang...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(93)80089-j
更新日期：1993-11-01 00:00:00
abstract：:Fentanyl, a potent analgesic drug, has traditionally been used intravenously in surgical or diagnostic operations. Formulations with fentanyl in oral transmucosal delivery system and in transdermal depot-patch have also been developed against breakthrough pain in cancer patients. In this report, LC-MS/MS methods to de...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.09.024
更新日期：2005-04-29 00:00:00
abstract：:An analytical methodology for the simultaneous determination of seven pharmaceuticals and two metabolites belonging to the non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics therapeutic groups was developed based on off-line solid-phase extraction and ultra-high performance liquid chromatography coupled to ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2014.06.017
更新日期：2015-03-15 00:00:00
abstract：:Much contemporary research of poorly water-soluble drugs focuses on amorphous solid dispersions (SDs) for oral drug delivery. Recently, a multifractal formalism has been introduced to describe the distribution of an inorganic carrier in SDs. The present work attempts to directly image model drugs by means of scanning ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.12.020
更新日期：2018-02-20 00:00:00
abstract：:The concentration of TiO(2) in a cream formulation has been non-destructively measured using Raman spectroscopy without further sample pretreatments. The distribution of TiO(2) particles in a highly viscous cream may not be homogeneous on a microscopic scale and local aggregation of the particles is possible; therefor...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2010.05.008
更新日期：2010-11-02 00:00:00
abstract：:Opiates are commonly abused substances, and forensic urine drug-testing for them requires gas chromatographic-mass spectrometric (GC-MS) confirmation. There are also medical reasons to test urine for opiates, and confirmation procedures other than GC-MS are often used for medical drug-testing. A thin-layer chromatogra...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00086-2
更新日期：1999-09-01 00:00:00
abstract：:The current importance of drugs of natural origin and their different phytotherapeutical preparations are mentioned. Analytical aspects related to vegetable drugs and their extracts are discussed. An overview is given on procedures used for the isolation of reference compounds, sample preparation for high-performance ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/0731-7085(89)80139-6
更新日期：1989-01-01 00:00:00
abstract：:Astemizole (AST), a second-generation antihistamine, is metabolized to desmethyl astemizole (DEA), and although it has been removed from the market for inducing QT interval prolongation, it has reemerged as a potential anticancer and antimalarial agent. This report describes a novel high-performance liquid chromatogra...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2015.04.036
更新日期：2015-10-10 00:00:00
abstract：:Isoniazid was subjected to different ICH prescribed stress conditions of thermal stress, hydrolysis, oxidation and photolysis. The drug was stable to dry heat (50 and 60 degrees C). It showed extensive decomposition under hydrolytic conditions, while it was only moderately sensitive to oxidation stress. The solid drug...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2006.10.013
更新日期：2007-03-12 00:00:00
abstract：:A direct enantioselective high-performance liquid chromatography was employed successfully for determination of the enantiomeric purity of levamisole. The elaborated method used S-naphthylethylcarbamoylated beta-cyclodextrin stationary phase in reversed-phase mode. The optimized mobile phase composition was acetonitri...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(00)00513-6
更新日期：2001-06-01 00:00:00
abstract：:Salvianolic acid B (SAB), tanshinone IIA (TS), ginsenoside Rb₁ (Rb₁), ginsenoside Rg₁ (Rg₁) and notoginsenoside R₁ (R₁) are major active ingredients of Fufang Danshen preparation (FDP) for its protective effects on myocardial ischemia. This study investigated the pharmacokinetics of marker compounds after oral adminis...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2012.03.058
更新日期：2012-08-01 00:00:00
abstract：:The stability of cisplatin and its monohydrated complex has been studied in blood, plasma and plasma ultrafiltrate at 37 degrees C (pH 7.4). Intact cisplatin and the monohydrated complex were determined by liquid chromatography with post-column derivatization. The half lives for cisplatin and the monohydrated complex ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(95)01292-s
更新日期：1995-04-01 00:00:00
abstract：:The analysis of carbimazole tablets in The British Pharmacopoeia, 1993, includes a quantitative thin layer chromatography (TLC) determination of methimazole. Repeated analysis of the same samples did not give similar results. The repeatability and reproducibility of the method was studied. It was proved that the resid...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(97)00119-2
更新日期：1998-01-01 00:00:00
abstract：:The use of multivariate spectrophotometric calibration is reported for the analysis of two decongestant tablets, where paracetamol is the principal component and diphenhydramine or phenylpropanolamine are the minor components. The resolution of these mixtures has been accomplished without prior separation or derivatis...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00029-1
更新日期：1999-06-01 00:00:00
abstract：:The chemical stability of ricobendazole (RBZ) was investigated using a stability-indicating high performance liquid chromatographic (HPLC) assay with ultraviolet detection. The degradation kinetics of RBZ in aqueous solution was evaluated as a function of pH, buffer strength and temperature. The oxidation reaction in ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2009.02.032
更新日期：2009-07-12 00:00:00
abstract：:A selective method for the determination of sulphobutylether-beta-cyclodextrin (SBECD) in human plasma has been developed and validated over the range 4-200 microg ml(-1). SBECD is extracted from plasma using end-capped cyclohexyl solid phase extraction cartridges. This is followed by high performance size exclusion c...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00283-6
更新日期：2000-06-01 00:00:00
abstract：:In this paper, we review recent research articles on liquid-phase microextraction of drug substances from biological fluids, such as plasma, serum, urine, and saliva. We focus on papers where liquid-phase microextraction is combined with liquid chromatography coupled with mass spectrometry (LC-MS), published in the pe...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章,评审
doi：10.1016/j.jpba.2020.113446
更新日期：2020-09-10 00:00:00
abstract：:General multistep methods are described for the screening of the chemical and the physical stability and/or reactivity of new drug candidates. The chemical reactivity is studied in aqueous buffer solutions; the rate of degradation is measured as a function of pH. The products of the reaction mixture are evaluated at s...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(90)80094-6
更新日期：1990-01-01 00:00:00
abstract：:A validated stability indicating RP-HPLC assay of doxofylline was developed by separating its related substances and degradants on LichrocartC18 (250 mm × 4.6 mm; 5 μm) column using 10 mM ammonium acetate and acetonitrile as a mobile phase in a gradient mode of elution at a flow rate of 1.0 mL/min at 30 °C. The column...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2013.02.004
更新日期：2013-05-05 00:00:00
abstract：:Methylnaltrexone (MNTX) is a novel peripherally acting μ-opioid antagonist that prevents peripheral side effects of opioid drugs such as constipation without affecting the analgesia. We developed a selective and sensitive assay to measure MTNX concentrations in human serum. The drug was measured after protein precipit...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.08.016
更新日期：2011-12-15 00:00:00
abstract：:As a preliminary study of the utility of the natural stable-isotopic differentiation of batch samples produced by different synthetic pathways, multi-stable-isotopic analyses (delta(13)C, delta(15)N, delta(18)O, deltaD) of 53 samples of the antiepileptic drug, Topiramate, produced by three different synthetic pathways...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.03.011
更新日期：2005-09-01 00:00:00
abstract：:The electrochemical behaviour of a platinum(II) anti-tumour drug (cis-platin) has been investigated at the platinised platinum and carbon paste electrodes using cyclic voltammetry. Measurements performed in neutral aqueous media at the platinised platinum electrode as a function of free chloride ions have enabled the ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(88)80011-6
更新日期：1988-01-01 00:00:00
abstract：:The application of potentiometric biosensors based on membrane ion-selective electrodes for flow injection analysis (FIA) is presented. The biosensors have been obtained by covalent binding of enzyme molecules directly to surface of ion-selective membranes. The biosensor/FIA systems enable the determination of urea an...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(98)00230-1
更新日期：1999-03-01 00:00:00
abstract：:The objective of this work was to develop and validate a rapid reversed-phase (RP) high-performance liquid chromatography (HPLC) method for the in vitro pharmaceutical characterization of dapivirine-loaded polymeric nanoparticles. Chromatographic runs were performed on a RP C18 column with a mobile phase comprising ac...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2010.01.007
更新日期：2010-06-05 00:00:00
