Characterizing biological products and assessing comparability following manufacturing changes. (Q30344134)

20 June 2017

title

Characterizing biological products and assessing comparability following manufacturing changes. (English)

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20 June 2017

Arthur J Chirino

1

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20 June 2017

Anthony Mire-Sluis

series ordinal

2

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20 June 2017

publication date

1 November 2004

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20 June 2017

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20 June 2017

volume

22

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20 June 2017

issue

11

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20 June 2017

page(s)

1383-1391

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The trials and tribulations of producing the first genetically engineered drug

20 June 2017

cites work

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Hyperosmotic stress and elevated pCO2 alter monoclonal antibody charge distribution and monosaccharide content

21 January 2018

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Effects of glucose, insulin, and cAMP on transcription of the serine dehydratase gene in rat liver

21 January 2018

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Optimizing the use of erythropoietic agents-- pharmacokinetic and pharmacodynamic considerations

21 January 2018

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In vivo trafficking and catabolism of IgG1 antibodies with Fc associated carbohydrates of differing structure

21 January 2018

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Effect of glycosylation on antibody function: implications for genetic engineering

21 January 2018

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Mapping of the C1q binding site on rituxan, a chimeric antibody with a human IgG1 Fc

21 January 2018

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Lack of fucose on human IgG1 N-linked oligosaccharide improves binding to human Fcgamma RIII and antibody-dependent cellular toxicity

21 January 2018

1 reference

The absence of fucose but not the presence of galactose or bisecting N-acetylglucosamine of human IgG1 complex-type oligosaccharides shows the critical role of enhancing antibody-dependent cellular cytotoxicity

21 January 2018

1 reference

Thrombocytopenia caused by the development of antibodies to thrombopoietin

21 January 2018

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Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin

21 January 2018

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Bioequivalence and the immunogenicity of biopharmaceuticals

21 January 2018

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Minimizing the immunogenicity of protein therapeutics

21 January 2018

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Degradation products of factor VIII which can lead to increased immunogenicity

21 January 2018

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Differential effects of three interferon betas on neutralising antibodies in patients with multiple sclerosis: a follow up study in an independent laboratory.

21 January 2018

1 reference

Development of a cytokine analog with enhanced stability using computational ultrahigh throughput screening

21 January 2018

1 reference

Carbohydrate analysis of a chimeric recombinant monoclonal antibody by capillary electrophoresis with laser-induced fluorescence detection

21 January 2018

1 reference

Multi-target PCR analysis by capillary electrophoresis and laser-induced fluorescence

21 January 2018

1 reference

Quantitative analysis of sugar constituents of glycoproteins by capillary electrophoresis

21 January 2018

1 reference

Species-specific variation in glycosylation of IgG: evidence for the species-specific sialylation and branch-specific galactosylation and importance for engineering recombinant glycoprotein therapeutics

21 January 2018

1 reference

Noncovalent labeling of proteins in capillary electrophoresis with laser-induced fluorescence detection

21 January 2018

1 reference

Rapid, sensitive sequencing of oligosaccharides from glycoproteins

21 January 2018

1 reference

Characterization of asparagine deamidation and aspartate isomerization in recombinant human interleukin-11.

21 January 2018

1 reference

Evaluation of genetic stability of recombinant human factor VIII by peptide mapping and on-line mass spectrometric analysis

21 January 2018

1 reference

NMR structure of the bovine prion protein

21 January 2018

1 reference

Modern applications of analytical ultracentrifugation

21 January 2018

1 reference

Modern analytical ultracentrifugation in protein science: a tutorial review

21 January 2018

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A method for directly fitting the time derivative of sedimentation velocity data and an alternative algorithm for calculating sedimentation coefficient distribution functions.

21 January 2018

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Assays for tumour necrosis factor and related cytokines

21 January 2018

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Kinase receptor activation (KIRA): a rapid and accurate alternative to end-point bioassays

21 January 2018

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A bead-based method for multiplexed identification and quantitation of DNA sequences using flow cytometry

21 January 2018

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The use of laser scanning cytometry to assess depth of penetration of adenovirus p53 gene therapy in human xenograft biopsies

21 January 2018

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Determinants of autoantibody induction by conjugated papillomavirus virus-like particles

21 January 2018

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Antigen presentation and T cell stimulation by dendritic cells

21 January 2018

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Helper T-cell-regulated B-cell immunity

21 January 2018

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Monitoring of immune responses to CA125 with an IFN-gamma ELISPOT assay

21 January 2018

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Strategies for detection, measurement and characterization of unwanted antibodies induced by therapeutic biologicals

21 January 2018

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Detection and characterization of antibodies to PEG-IFN-alpha2b using surface plasmon resonance

21 January 2018

1 reference

Advances in surface plasmon resonance biosensor analysis

21 January 2018

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Immunogenicity of biopharmaceuticals in laboratory animals

21 January 2018

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Expression of factor VIII in recombinant and transgenic systems

21 January 2018

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'Top down' protein characterization via tandem mass spectrometry

21 January 2018

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Processing of C-terminal lysine and arginine residues of proteins isolated from mammalian cell culture.

21 January 2018

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Rational design of a potent, long-lasting form of interferon: a 40 kDa branched polyethylene glycol-conjugated interferon alpha-2a for the treatment of hepatitis C.

21 January 2018

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PEGylated antibodies and antibody fragments for improved therapy: a review

21 January 2018

1 reference

NMR structure determination of proteins and protein complexes larger than 20 kDa

21 January 2018

1 reference

Purification and characterization of three forms of differently glycosylated recombinant human granulocyte-macrophage colony-stimulating factor

21 January 2018

1 reference

7 January 2021

The asialoglycoprotein receptor: relationships between structure, function, and expression

1 reference

7 January 2021

The effect of the removal of sialic acid, galactose and total carbohydrate on the functional activity of Campath-1H

1 reference

7 January 2021

Immune responses to therapeutic proteins in humans--clinical significance, assessment and prediction

1 reference

7 January 2021

Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-alpha) in normal and transgenic mice

1 reference

7 January 2021

Interferon beta neutralizing antibodies in multiple sclerosis: neutralizing activity and cross-reactivity with three different preparations

1 reference

7 January 2021

Capillary electrophoresis for the analysis of biopolymers

1 reference

7 January 2021

High-sensitivity laser-induced fluorescence detection of native proteins in capillary electrophoresis

1 reference

7 January 2021

Laser-induced fluorescence technique for DNA and proteins separated by capillary electrophoresis

1 reference

7 January 2021

Validation of an HPLC method for the analysis of the charge heterogeneity of the recombinant monoclonal antibody IDEC-C2B8 after papain digestion

1 reference

7 January 2021

Isolation and characterization of a monomethioninesulfoxide variant of interferon alpha-2b

1 reference

7 January 2021

Peptide mapping on HIV polypeptides expressed in Escherichia coli. Quality control of different batches and identification of tryptic fragments containing residues of aromatic amino acids or cysteine

1 reference

7 January 2021

Structure determination of the intact major sialylated oligosaccharide chains of recombinant human erythropoietin expressed in Chinese hamster ovary cells

1 reference

7 January 2021

Structure of the saponin adjuvant QS-21 and its base-catalyzed isomerization product by 1H and natural abundance 13C NMR spectroscopy

1 reference

7 January 2021

Comparative structural study of the mannosylated-lipoarabinomannans from Mycobacterium bovis BCG vaccine strains: characterization and localization of succinates

1 reference

7 January 2021

The use of circular dichroism in the investigation of protein structure and function.

1 reference

7 January 2021

Interleukin-1 receptor (IL-1R) liquid formulation development using differential scanning calorimetry

1 reference

7 January 2021

The stability factor: importance in formulation development

1 reference

7 January 2021

Light scattering and viscosity study of heat aggregation of insulin

1 reference

7 January 2021

Size-distribution analysis of proteins by analytical ultracentrifugation: strategies and application to model systems

1 reference

7 January 2021

A case study and use of sedimentation equilibrium analytical ultracentrifugation as a tool for biopharmaceutical development

1 reference

7 January 2021

M-07e human leukemic factor-dependent cell line provides a rapid and sensitive bioassay for the human cytokines GM-CSF and IL-3.

1 reference

7 January 2021

Simultaneous measurement of six cytokines in a single sample of human tears using microparticle-based flow cytometry: allergics vs. non-allergics

1 reference

7 January 2021

EGF induces nuclear translocation of STAT2 without tyrosine phosphorylation in intestinal epithelial cells

1 reference

7 January 2021

Comparison of flow cytometry and laser scanning cytometry for the intracellular evaluation of adenoviral infectivity and p53 protein expression in gene therapy

1 reference

7 January 2021

Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

1 reference

7 January 2021

A sensitive radioimmunoprecipitation assay for the detection and quantitation of antibodies to the envelope glycoprotein gp120 of the human immunodeficiency virus (HIV-1).

1 reference

7 January 2021

Evaluation of methods to detect and characterize antibodies against recombinant human erythropoietin

1 reference

7 January 2021

Identification of multiple sources of charge heterogeneity in a recombinant antibody.

1 reference

7 January 2021

Antioxidants for Prevention of Methionine Oxidation in Recombinant Monoclonal Antibody HER2

1 reference

7 January 2021

Identifiers

DOI

10.1038/NBT1030

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Dimensions Publication ID

20 June 2017

1023090889

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