Advances and challenges in analytical characterization of biotechnology products: mass spectrometry-based approaches to study properties and behavior of protein therapeutics

scientific article

Advances and challenges in analytical characterization of biotechnology products: mass spectrometry-based approaches to study properties and behavior of protein therapeutics is …
instance of (P31):
review articleQ7318358
scholarly articleQ13442814

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P356DOI10.1016/J.BIOTECHADV.2011.05.006
P932PMC publication ID3176981
P698PubMed publication ID21619926
P5875ResearchGate publication ID51172237

P2093author name stringIgor A Kaltashov
Rinat R Abzalimov
Cedric E Bobst
Guanbo Wang
Shunhai Wang
Burcu Baykal
P2860cites workElectrospray ionization mass spectrometry of highly heterogeneous protein systems: protein ion charge state assignment via incomplete charge reductionQ84788287
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Analysis of posttranslational modifications of proteins by tandem mass spectrometry.Q30354938
Beyond gene sequencing: analysis of protein structure with mass spectrometry.Q30371170
Mass spectrometry combined with oxidative labeling for exploring protein structure and folding.Q30379641
Post-translational modifications differentially affect IgG1 conformation and receptor binding.Q30384877
The utility of hydrogen/deuterium exchange mass spectrometry in biopharmaceutical comparability studiesQ30401825
De novo sequencing of peptides by MS/MS.Q30938649
Peptide and protein de novo sequencing by mass spectrometryQ31014914
Glycosaminoglycans as naturally occurring combinatorial libraries: developing a mass spectrometry-based strategy for characterization of anti-thrombin interaction with low molecular weight heparin and heparin oligomersQ33292010
Mass spectrometry for structural characterization of therapeutic antibodiesQ33362439
Toward top-down determination of PEGylation site using MALDI in-source decay MS analysisQ33385574
Mass spectrometric analysis of innovator, counterfeit, and follow-on recombinant human growth hormoneQ33410181
Determination of the mechanism of action of anti-FasL antibody by epitope mapping and homology modelingQ33480207
H/D exchange and mass spectrometry in the studies of protein conformation and dynamics: is there a need for a top-down approach?Q33585139
MALDI linear TOF mass spectrometry of PEGylated (glyco)proteinsQ33596015
Characterization of the glycosylation occupancy and the active site in the follow-on protein therapeutic: TNK-tissue plasminogen activatorQ33605997
Assessment of the quality and structural integrity of a complex glycoprotein mixture following extraction from the formulated biopharmaceutical drug productQ33676479
Conformation and dynamics of biopharmaceuticals: transition of mass spectrometry-based tools from academe to industryQ33684631
Noncanonical interactions between serum transferrin and transferrin receptor evaluated with electrospray ionization mass spectrometryQ33929235
Acid-catalyzed oxygen-18 labeling of peptidesQ33943921
Protein-peptide affinity determination using an h/d exchange dilution strategy: application to antigen-antibody interactionsQ34101341
Existence of a noncanonical state of iron-bound transferrin at endosomal pH revealed by hydrogen exchange and mass spectrometryQ34102858
Mass spectrometric analysis of intact human monoclonal antibody aggregates fractionated by size-exclusion chromatography.Q34127391
Mass spectrometry of oligosaccharides.Q34299101
Structural and functional characterization of the trifunctional antibody catumaxomabQ34619043
Studies of biomolecular conformations and conformational dynamics by mass spectrometryQ34811742
Phenotype, diagnosis, and treatment of Gaucher's diseaseQ34907714
Effective drug delivery by PEGylated drug conjugatesQ35058925
Mass spectrometry and glycomicsQ35097817
Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologiesQ35232337
Hydrogen exchange methods to study protein foldingQ35850714
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Hydrogen exchange and mass spectrometry: A historical perspectiveQ36550545
A review of quantitative methods for proteomic studiesQ36680048
Applications of mass spectrometry for the structural characterization of recombinant protein pharmaceuticalsQ36780879
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Top-down MS, a powerful complement to the high capabilities of proteolysis proteomics.Q37004962
Detection and characterization of altered conformations of protein pharmaceuticals using complementary mass spectrometry-based approaches.Q37065997
Obstacles and pitfalls in the PEGylation of therapeutic proteins.Q37088095
Principles, approaches, and challenges for predicting protein aggregation rates and shelf lifeQ37236306
The impact of PEGylation on biological therapiesQ37263179
IgG glycosylation analysisQ37391496
Emerging methods for the production of homogeneous human glycoproteinsQ37417435
18O2-labeling in quantitative proteomic strategies: a status reportQ37429056
Bioanalysis of recombinant proteins and antibodies by mass spectrometryQ37452812
Strategies for analysis of the glycosylation of proteins: current status and future perspectivesQ37511909
Pharmacokinetics of biotech drugs: peptides, proteins and monoclonal antibodiesQ37585356
Carbohydrate analysis throughout the development of a protein therapeuticQ37627225
Pharmacological significance of glycosylation in therapeutic proteinsQ37628240
Protein aggregation--pathways and influencing factorsQ37699481
A systematic approach to protein glycosylation analysis: a path through the mazeQ37790268
Critical comparison of MS and immunoassays for the bioanalysis of therapeutic antibodiesQ37810155
Discrimination among IgG1-kappa monoclonal antibodies produced by two cell lines using charge state distributions in nanoESI-TOF mass spectraQ39878491
Insertion of the designed helical linker led to increased expression of tf-based fusion proteinsQ39918619
Do ionic charges in ESI MS provide useful information on macromolecular structure?Q40074233
Probing molecular interactions in intact antibody: antigen complexes, an electrospray time-of-flight mass spectrometry approachQ40198247
Conformational changes in oxidatively stressed monoclonal antibodies studied by hydrogen exchange mass spectrometryQ40454983
Positional isomers of monopegylated interferon alpha-2a: isolation, characterization, and biological activityQ41112762
Impact of oxidation on protein therapeutics: conformational dynamics of intact and oxidized acid-β-glucocerebrosidase at near-physiological pH.Q41454207
Studying noncovalent protein complexes by electrospray ionization mass spectrometryQ41671168
Structural characterization of the maytansinoid-monoclonal antibody immunoconjugate, huN901-DM1, by mass spectrometryQ42122777
Potential aggregation prone regions in biotherapeutics: A survey of commercial monoclonal antibodies.Q43070206
Resolving disulfide structural isoforms of IgG2 monoclonal antibodies by ion mobility mass spectrometryQ43778556
High resolution, high-throughput amide deuterium exchange-mass spectrometry (DXMS) determination of protein binding site structure and dynamics: utility in pharmaceutical design.Q43884669
Dissociations of disulfide-linked gaseous polypeptide/protein anions: ion chemistry with implications for protein identification and characterizationQ44367851
Isolation, structural characterization, and antiviral activity of positional isomers of monopegylated interferon alpha-2a (PEGASYS).Q44487898
Evidence for trisulfide bonds in a recombinant variant of a human IgG2 monoclonal antibody.Q45932901
Mass spectrometry detection and characterization of noncovalent protein complexesQ46110253
Gas-phase proton-transfer chemistry coupled with TOF mass spectrometry and ion mobility-MS for the facile analysis of poly(ethylene glycols) and PEGylated polypeptide conjugatesQ46341961
Analysis of the composition of immunoconjugates using size-exclusion chromatography coupled to mass spectrometryQ46536053
Towards absolute quantification of therapeutic monoclonal antibody in serum by LC-MS/MS using isotope-labeled antibody standard and protein cleavage isotope dilution mass spectrometryQ46605479
Preparation and characterization of monopegylated human granulocyte-macrophage colony-stimulating factorQ46750776
Mass measurement and top-down HPLC/MS analysis of intact monoclonal antibodies on a hybrid linear quadrupole ion trap-Orbitrap mass spectrometerQ46905334
Optimization of a reversed-phase high-performance liquid chromatography/mass spectrometry method for characterizing recombinant antibody heterogeneity and stabilityQ46920795
A sensitive and high-throughput LC-MS/MS method for the quantification of pegylated-interferon-alpha2a in human serum using monolithic C18 solid phase extraction for enrichmentQ47785048
Expression, purification, and characterization of rat interferon-beta, and preparation of an N-terminally PEGylated form with improved pharmacokinetic parametersQ47995804
Direct monitoring of heat-stressed biopolymers with temperature-controlled electrospray ionization mass spectrometry.Q50684953
A universal strategy for development of a method for absolute quantification of therapeutic monoclonal antibodies in biological matrices using differential dimethyl labeling coupled with ultra performance liquid chromatography-tandem mass spectrometQ51608443
Rapid whole monoclonal antibody analysis by mass spectrometry: An ultra scale-down study of the effect of harvesting by centrifugation on the post-translational modification profile.Q51773472
Molecular mass analysis of antibodies by on-line SEC-MS.Q51791478
Identification of intermolecular disulfide linkages in underivatised peptides using negative ion electrospray mass spectrometry. A joint experimental and theoretical study.Q53572951
Characterisation of a novel growth hormone variant comprising a thioether link between Cys182 and Cys189.Q54439520
Bio-affinity characterization mass spectrometryQ58069446
Comment on Houde, D; Berkowitz, S. A; Engen, J. R, The utility of hydrogen/deuterium exchange mass spectrometry in biopharmaceutical comparability studies. J. Pharm. Sci. 2011, 100, 2071-2086Q58557043
Identification of sites of degradation in a therapeutic monoclonal antibody by peptide mappingQ67977680
Localization of O-glycosylation sites in peptides by electron capture dissociation in a Fourier transform mass spectrometerQ73144880
Direct identification of intramolecular disulfide links in peptides using negative ion electrospray mass spectra of underivatised peptides. A joint experimental and theoretical studyQ81300702
Single particle reconstruction of the human apo-transferrin-transferrin receptor complexQ81606083
Quantification of sifuvirtide in monkey plasma by an on-line solid-phase extraction procedure combined with liquid chromatography/electrospray ionization tandem mass spectrometryQ81657723
Top-down N-terminal sequencing of Immunoglobulin subunits with electrospray ionization time of flight mass spectrometryQ82205512
Characterization of trisulfide modification in antibodiesQ82565568
Elucidation of PEGylation site with a combined approach of in-source fragmentation and CID MS/MSQ83067154
Epitope mapping by amide hydrogen/deuterium exchange coupled with immobilization of antibody, on-line proteolysis, liquid chromatography and mass spectrometryQ83240189
P433issue1
P921main subjectbiotechnologyQ7108
P304page(s)210-222
P577publication date2011-05-17
P1433published inBiotechnology AdvancesQ4915328
P1476titleAdvances and challenges in analytical characterization of biotechnology products: mass spectrometry-based approaches to study properties and behavior of protein therapeutics
P478volume30

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cites work (P2860)
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