Accelerated formulation development of monoclonal antibodies (mAbs) and mAb-based modalities: review of methods and tools (Q38313350)

2 September 2017

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title

Accelerated formulation development of monoclonal antibodies (mAbs) and mAb-based modalities: review of methods and tools (English)

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2 September 2017

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Vladimir I Razinkov

1

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PubMed ID

25576149

2 September 2017

Michael J Treuheit

series ordinal

2

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PubMed ID

25576149

2 September 2017

Gerald W Becker

series ordinal

3

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2 September 2017

9 January 2015

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Journal of Biomolecular Screening

2 September 2017

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2 September 2017

20

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2 September 2017

4

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2 September 2017

468-483

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Potent antibody therapeutics by design

2 September 2017

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https://api.crossref.org/works/10.1177%2F1087057114565593

Upping the ante on antibodies.

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Advances in the production and downstream processing of antibodies

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Antibody structure, instability, and formulation

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Formulation and delivery issues for monoclonal antibody therapeutics

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Stability of protein pharmaceuticals: an update

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Forced degradation of therapeutic proteins.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

The thermal stability of immunoglobulin: unfolding and aggregation of a multi-domain protein

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Salting the charged surface: pH and salt dependence of protein G B1 stability

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Comparison of high-throughput biophysical methods to identify stabilizing excipients for a model IgG2 monoclonal antibody: conformational stability and kinetic aggregation measurements

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Evaluation of fluorescence-based thermal shift assays for hit identification in drug discovery

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

High throughput thermostability screening of monoclonal antibody formulations

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

High-throughput melting-temperature analysis of a monoclonal antibody by differential scanning fluorimetry in the presence of surfactants

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

A high throughput protein formulation platform: case study of salmon calcitonin

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

High-throughput thermal stability analysis of a monoclonal antibody by attenuated total reflection FT-IR spectroscopic imaging

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies.

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Auristatin antibody drug conjugate physical instability and the role of drug payload

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Engineered antibody-drug conjugates with defined sites and stoichiometries of drug attachment.

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Bispecific antibodies with native chain structure.

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

A broad range of Fab stabilities within a host of therapeutic IgGs.

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Biophysical properties of human antibody variable domains

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Stability engineering of the human antibody repertoire

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Effect of additives on protein aggregation.

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Molecular origins of osmotic second virial coefficients of proteins

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Colloidal behavior of proteins: effects of the second virial coefficient on solubility, crystallization and aggregation of proteins in aqueous solution

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

High throughput formulation screening for global aggregation behaviors of three monoclonal antibodies

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

A critical evaluation of self-interaction chromatography as a predictive tool for the assessment of protein-protein interactions in protein formulation development: a case study of a therapeutic monoclonal antibody

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Effects of ionic strength and sugars on the aggregation propensity of monoclonal antibodies: influence of colloidal and conformational stabilities

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

High-throughput assessment of thermal and colloidal stability parameters for monoclonal antibody formulations

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Coarse-grained model for colloidal protein interactions, B(22), and protein cluster formation

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Native-state solubility and transfer free energy as predictive tools for selecting excipients to include in protein formulation development studies

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Application of a high-throughput screening procedure with PEG-induced precipitation to compare relative protein solubility during formulation development with IgG1 monoclonal antibodies

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Quantitative evaluation of colloidal stability of antibody solutions using PEG-induced liquid-liquid phase separation.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

A critical review of methods for size characterization of non-particulate protein aggregates

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Modern analytical ultracentrifugation in protein science: a tutorial review

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Size-exclusion chromatography with on-line light-scattering, absorbance, and refractive index detectors for studying proteins and their interactions.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Phase transitions in human IgG solutions

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Classification and characterization of therapeutic antibody aggregates

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Developing novel therapeutic approaches to frailty

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Anion binding mediated precipitation of a peptibody

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Comparison of soluble decoy IgG fusion proteins of BAFF-R and BCMA as antagonists for BAFF.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Monoclonal antibody conjugates of doxorubicin prepared with branched peptide linkers: inhibition of aggregation by methoxytriethyleneglycol chains

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Prediction of posttranslational modification of proteins from their amino acid sequence

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Prediction of reversibly oxidized protein cysteine thiols using protein structure properties

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Formation of pyroglutamic acid from N-terminal glutamic acid in immunoglobulin gamma antibodies

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Selective deamidation of recombinant human stem cell factor during in vitro aging: isolation and characterization of the aspartyl and isoaspartyl homodimers and heterodimers

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Determination of haemoglobin A(1c) by liquid chromatography using a new cation-exchange column

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Effect of methionine oxidation of a recombinant monoclonal antibody on the binding affinity to protein A and protein G.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Methionine, tryptophan, and histidine oxidation in a model protein, PTH: mechanisms and stabilization

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Process analytics for purification of monoclonal antibodies

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

A high-throughput UPLC method for the characterization of chemical modifications in monoclonal antibody molecules

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Multiproduct high-resolution monoclonal antibody charge variant separations by pH gradient ion-exchange chromatography

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Automated tryptic digestion procedure for HPLC/MS/MS peptide mapping of immunoglobulin gamma antibodies in pharmaceutics

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

A platform for characterizing therapeutic monoclonal antibody breakdown products by 2D chromatography and top-down mass spectrometry

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Mass spectrometric-based stable isotopic 2-aminobenzoic acid glycan mapping for rapid glycan screening of biotherapeutics

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Nanobodies: natural single-domain antibodies

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

The influence of charge distribution on self-association and viscosity behavior of monoclonal antibody solutions

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Weak interactions govern the viscosity of concentrated antibody solutions: high-throughput analysis using the diffusion interaction parameter

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Measurement of rheologic property of blood by a falling-ball blood viscometer

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Viscosity of concentrated therapeutic protein compositions

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Factors affecting the viscosity in high concentration solutions of different monoclonal antibodies.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

High-throughput dynamic light scattering method for measuring viscosity of concentrated protein solutions

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Viscosity measurements of antibody solutions by photon correlation spectroscopy: an indirect approach - limitations and applicability for high-concentration liquid protein solutions

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

High-throughput screening and stability optimization of anti-streptavidin IgG1 and IgG2 formulations

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Formulation development of antibodies using robotic system and high-throughput laboratory (HTL).

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Future of antibody purification

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Downstream processing of monoclonal antibodies--application of platform approaches

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

An efficient method for the detection and elimination of systematic error in high-throughput screening.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

A Simple Statistical Parameter for Use in Evaluation and Validation of High Throughput Screening Assays

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Characterization of a monoclonal antibody cell culture production process using a quality by design approach.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Quality by design: impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Screening of monoclonal antibody formulations based on high-throughput thermostability and viscosity measurements: design of experiment and statistical analysis

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Radar chart array analysis to visualize effects of formulation variables on IgG1 particle formation as measured by multiple analytical techniques

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Improved data visualization techniques for analyzing macromolecule structural changes

21 January 2018

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https://api.crossref.org/works/10.1177%2F1087057114565593

Using empirical phase diagrams to understand the role of intramolecular dynamics in immunoglobulin G stability

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Formulation design and high-throughput excipient selection based on structural integrity and conformational stability of dilute and highly concentrated IgG1 monoclonal antibody solutions

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

High-throughput biophysical analysis and data visualization of conformational stability of an IgG1 monoclonal antibody after deglycosylation

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Aspartate isomerization in the complementarity-determining regions of two closely related monoclonal antibodies.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Isoaspartate in peptides and proteins: formation, significance, and analysis

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Dimers and multimers of monoclonal IgG1 exhibit higher in vitro binding affinities to Fcgamma receptors

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Fragmentation of a highly purified monoclonal antibody attributed to residual CHO cell protease activity

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Structure-immunogenicity relationships of therapeutic proteins

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Incorporating post-translational modifications and unnatural amino acids into high-throughput modeling of protein structures.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Prediction of posttranslational modification sites from amino acid sequences with kernel methods.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Studying post-translational modifications with protein interaction networks

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Prediction of post-translational glycosylation and phosphorylation of proteins from the amino acid sequence

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

PASTA 2.0: an improved server for protein aggregation prediction

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

GAP: towards almost 100 percent prediction for β-strand-mediated aggregating peptides with distinct morphologies.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Conformational stability as a design target to control protein aggregation.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Design of therapeutic proteins with enhanced stability.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Structure based descriptors for the estimation of colloidal interactions and protein aggregation propensities

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Phase separation in solutions with specific and nonspecific interactions.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Concentration dependent viscosity of monoclonal antibody solutions: explaining experimental behavior in terms of molecular properties.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

High-throughput thermal scanning for protein stability: making a good technique more robust.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Temperature-ramped studies on the aggregation, unfolding, and interaction of a therapeutic monoclonal antibody.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Biophysical characterization of influenza virus subpopulations using field flow fractionation and multiangle light scattering: correlation of particle counts, size distribution and infectivity

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Improved particle counting and size distribution determination of aggregated virus populations by asymmetric flow field-flow fractionation and multiangle light scattering techniques

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Liquid formulations for stabilizing IgMs during physical stress and long-term storage

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Enlarging the repertoire of therapeutic monoclonal antibodies platforms: domesticating half molecule exchange to produce stable IgG4 and IgG1 bispecific antibodies

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Characterization of biopharmaceuticals by NMR spectroscopy

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Why forces between proteins follow different Hofmeister series for pH above and below pI

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Nanoelectrospray peptide mapping revisited: Composite survey spectra allow high dynamic range protein characterization without LCMS on an orbitrap mass spectrometer

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

Dipole-dipole interaction in antibody solutions: correlation with viscosity behavior at high concentration

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1087057114565593

21 January 2018

Identifiers

DOI

10.1177/1087057114565593

1 reference

2 September 2017

1 reference

PubMed ID

25576149