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Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics

PloS one, 2016-08, Vol.11 (8), p.e0159328-e0159328

2016

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Classification and Characterization of Therapeutic Antibody Aggregates

The Journal of biological chemistry, 2011-07, Vol.286 (28), p.25118-25133

2011

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Chemical Modifications in Therapeutic Protein Aggregates Generated under Different Stress Conditions

The Journal of biological chemistry, 2011-07, Vol.286 (28), p.25134-25144

2011

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Characterization of Subvisible Particles in Biotherapeutic Prefilled Syringes: The Role of Polysorbate and Protein on the Formation of Silicone Oil and Protein Subvisible Particles After Drop Shock

Journal of pharmaceutical sciences, 2020-01, Vol.109 (1), p.640-645

2020

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High throughput thermostability screening of monoclonal antibody formulations

Journal of pharmaceutical sciences, 2010-04, Vol.99 (4), p.1707-1720

2010

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High‐Throughput Assessment of Thermal and Colloidal Stability Parameters for Monoclonal Antibody Formulations

Journal of pharmaceutical sciences, 2011-12, Vol.100 (12), p.5126-5141

2011

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

Analytical biochemistry, 2010-04, Vol.399 (1), p.141-143

2010

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Effect of Ions on Agitation- and Temperature-Induced Aggregation Reactions of Antibodies

Pharmaceutical research, 2009-04, Vol.26 (4), p.903-913

2009

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Development of a Human Antibody Tolerant Mouse Model to Assess the Immunogenicity Risk Due to Aggregated Biotherapeutics

Journal of pharmaceutical sciences, 2013-10, Vol.102 (10), p.3545-3555

2013

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Classification of protein aggregates

Journal of pharmaceutical sciences, 2012-02, Vol.101 (2), p.493-498

2012

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Screening of Monoclonal Antibody Formulations Based on High-Throughput Thermostability and Viscosity Measurements: Design of Experiment and Statistical Analysis

Journal of pharmaceutical sciences, 2011-04, Vol.100 (4), p.1330-1340

2011

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Immunogenicity of Therapeutic Protein Aggregates

Journal of pharmaceutical sciences, 2016-02, Vol.105 (2), p.417-430

2016

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Detection of IgG Aggregation by a High Throughput Method Based on Extrinsic Fluorescence

Journal of pharmaceutical sciences, 2010-06, Vol.99 (6), p.2598-2608

2010

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Effect of pH, Temperature, and Salt on the Stability of Escherichia coli- and Chinese Hamster Ovary Cell-Derived IgG1 Fc

Biochemistry (Easton), 2012-12, Vol.51 (50), p.10056-10065

2012

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Stress Factors in mAb Drug Substance Production Processes: Critical Assessment of Impact on Product Quality and Control Strategy

Journal of pharmaceutical sciences, 2020-01, Vol.109 (1), p.116-133

2020

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Stress Factors in Primary Packaging, Transportation and Handling of Protein Drug Products and Their Impact on Product Quality

Journal of pharmaceutical sciences, 2022-04, Vol.111 (4), p.887-902

2022

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Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality

Journal of pharmaceutical sciences, 2022-04, Vol.111 (4), p.868-886

2022

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Highly Aggregated Antibody Therapeutics Can Enhance the in Vitro Innate and Late-stage T-cell Immune Responses

The Journal of biological chemistry, 2012-07, Vol.287 (30), p.25266-25279

2012

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A Cluster of Articles in Memory of Wim Jiskoot, Ph.D

Journal of pharmaceutical sciences, 2022-04, Vol.111 (4), p.859-860

2022

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Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges

Journal of pharmaceutical sciences, 2016-05, Vol.105 (5), p.1567-1575

2016

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Silicone Oil Particles in Prefilled Syringes With Human Monoclonal Antibody, Representative of Real-World Drug Products, Did Not Increase Immunogenicity in In Vivo and In Vitro Model Systems

Journal of pharmaceutical sciences, 2020-01, Vol.109 (1), p.845-853

2020

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Ion‐specific modulation of protein interactions: Anion‐induced, reversible oligomerization of a fusion protein

Protein science, 2009-01, Vol.18 (1), p.169-179

2009

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A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic

Pharmaceutical research, 2024-04, Vol.41 (4), p.651-672

2024

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Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products

Journal of pharmaceutical sciences, 2024-05, Vol.113 (5), p.1401-1414

2024

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A critical review of analytical methods for subvisible and visible particles

Current pharmaceutical biotechnology, 2009-06, Vol.10 (4), p.373-381

2009

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Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics

Classification and Characterization of Therapeutic Antibody Aggregates

Chemical Modifications in Therapeutic Protein Aggregates Generated under Different Stress Conditions

Characterization of Subvisible Particles in Biotherapeutic Prefilled Syringes: The Role of Polysorbate and Protein on the Formation of Silicone Oil and Protein Subvisible Particles After Drop Shock

High throughput thermostability screening of monoclonal antibody formulations

High‐Throughput Assessment of Thermal and Colloidal Stability Parameters for Monoclonal Antibody Formulations

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

Effect of Ions on Agitation- and Temperature-Induced Aggregation Reactions of Antibodies

Development of a Human Antibody Tolerant Mouse Model to Assess the Immunogenicity Risk Due to Aggregated Biotherapeutics

Classification of protein aggregates

Screening of Monoclonal Antibody Formulations Based on High-Throughput Thermostability and Viscosity Measurements: Design of Experiment and Statistical Analysis

Immunogenicity of Therapeutic Protein Aggregates

Detection of IgG Aggregation by a High Throughput Method Based on Extrinsic Fluorescence

Effect of pH, Temperature, and Salt on the Stability of Escherichia coli- and Chinese Hamster Ovary Cell-Derived IgG1 Fc

Stress Factors in mAb Drug Substance Production Processes: Critical Assessment of Impact on Product Quality and Control Strategy

Stress Factors in Primary Packaging, Transportation and Handling of Protein Drug Products and Their Impact on Product Quality

Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality

Highly Aggregated Antibody Therapeutics Can Enhance the in Vitro Innate and Late-stage T-cell Immune Responses

A Cluster of Articles in Memory of Wim Jiskoot, Ph.D

Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges

Silicone Oil Particles in Prefilled Syringes With Human Monoclonal Antibody, Representative of Real-World Drug Products, Did Not Increase Immunogenicity in In Vivo and In Vitro Model Systems

Ion‐specific modulation of protein interactions: Anion‐induced, reversible oligomerization of a fusion protein

A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic

Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products

A critical review of analytical methods for subvisible and visible particles

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