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Potential induction of anti-PEG antibodies and complement activation toward PEGylated therapeutics

Drug discovery today, 2014-12, Vol.19 (12), p.1945-1952

2014

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Colloidal Instability Fosters Agglomeration of Subvisible Particles Created by Rupture of Gels of a Monoclonal Antibody Formed at Silicone Oil-Water Interfaces

Journal of pharmaceutical sciences, 2016-08, Vol.105 (8), p.2338-2348

2016

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Impact of Ethylene Oxide Sterilization of Polymer-Based Prefilled Syringes on Chemical Degradation of a Model Therapeutic Protein During Storage

Journal of pharmaceutical sciences, 2019-01, Vol.108 (1), p.770-774

2019

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Gelation of a Monoclonal Antibody at the Silicone Oil–Water Interface and Subsequent Rupture of the Interfacial Gel Results in Aggregation and Particle Formation

Journal of pharmaceutical sciences, 2015-04, Vol.104 (4), p.1282-1290

2015

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Conjugation of Emtansine Onto Trastuzumab Promotes Aggregation of the Antibody–Drug Conjugate by Reducing Repulsive Electrostatic Interactions and Increasing Hydrophobic Interactions

Journal of pharmaceutical sciences, 2019-06, Vol.108 (6), p.1973-1983

2019

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Microparticles and Nanoparticles Delivered in Intravenous Saline and in an Intravenous Solution of a Therapeutic Antibody Product

Journal of pharmaceutical sciences, 2017-02, Vol.106 (2), p.511-520

2017

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Immunogenicity of aggregates of recombinant human growth hormone in mouse models

Journal of pharmaceutical sciences, 2009-09, Vol.98 (9), p.3247-3264

2009

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Effects of Product Handling Parameters on Particle Levels in a Commercial Factor VIII Product: Impacts and Mitigation

Journal of pharmaceutical sciences, 2019-01, Vol.108 (1), p.775-786

2019

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Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution

Journal of pharmaceutical sciences, 2009-09, Vol.98 (9), p.3167-3181

2009

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Silicone oil microdroplets and protein aggregates in repackaged bevacizumab and ranibizumab: effects of long-term storage and product mishandling

Investigative ophthalmology & visual science, 2011-02, Vol.52 (2), p.1023-1034

2011

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Analytical approaches to assess the degradation of therapeutic proteins

TrAC, Trends in analytical chemistry (Regular ed.), 2013-09, Vol.49, p.118-125

2013

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Some Lessons Learned From a Comparison Between Sedimentation Velocity Analytical Ultracentrifugation and Size Exclusion Chromatography to Characterize and Quantify Protein Aggregates

Journal of pharmaceutical sciences, 2017-08, Vol.106 (8), p.2178-2186

2017

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The Effects of Excipients on Protein Aggregation During Agitation: An Interfacial Shear Rheology Study

Journal of pharmaceutical sciences, 2013-08, Vol.102 (8), p.2460-2470

2013

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Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation

Pharmaceutical research, 2003-09, Vol.20 (9), p.1325-1336

2003

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Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: Essential need to use orthogonal methods to assure the quality of therapeutic protein products

Journal of pharmaceutical sciences, 2010-05, Vol.99 (5), p.2200-2208

2010

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Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals

Journal of pharmaceutical sciences, 2011-10, Vol.100 (10), p.4158-4170

2011

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In Vivo Analysis of the Potency of Silicone Oil Microdroplets as Immunological Adjuvants in Protein Formulations

Journal of pharmaceutical sciences, 2015-11, Vol.104 (11), p.3681-3690

2015

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Effects of Solution Conditions, Processing Parameters, and Container Materials on Aggregation of a Monoclonal Antibody during Freeze-Thawing

Journal of pharmaceutical sciences, 2008-05, Vol.97 (5), p.1801-1812

2008

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Investigation of the Immunogenicity of Different Types of Aggregates of a Murine Monoclonal Antibody in Mice

Pharmaceutical research, 2015-02, Vol.32 (2), p.430-444

2015

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Effect of the Siliconization Method on Particle Generation in a Monoclonal Antibody Formulation in Pre-filled Syringes

Journal of pharmaceutical sciences, 2015-05, Vol.104 (5), p.1601-1609

2015

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IgG1 Aggregation and Particle Formation Induced by Silicone–water Interfaces on Siliconized Borosilicate Glass Beads: A Model for Siliconized Primary Containers

Journal of pharmaceutical sciences, 2013-03, Vol.102 (3), p.852-865

2013

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Ionic Strength Affects Tertiary Structure and Aggregation Propensity of a Monoclonal Antibody Adsorbed to Silicone Oil–Water Interfaces

Journal of pharmaceutical sciences, 2013-02, Vol.102 (2), p.429-440

2013

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Response of a concentrated monoclonal antibody formulation to high shear

Biotechnology and bioengineering, 2009-08, Vol.103 (5), p.936-943

2009

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Understanding and Modulating Opalescence and Viscosity in a Monoclonal Antibody Formulation

Journal of pharmaceutical sciences, 2010-01, Vol.99 (1), p.82-93

2010

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Immunogenicity of Structurally Perturbed Hen Egg Lysozyme Adsorbed to Silicone Oil Microdroplets in Wild-Type and Transgenic Mouse Models

Journal of pharmaceutical sciences, 2017-06, Vol.106 (6), p.1519-1527

2017

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Potential induction of anti-PEG antibodies and complement activation toward PEGylated therapeutics

Colloidal Instability Fosters Agglomeration of Subvisible Particles Created by Rupture of Gels of a Monoclonal Antibody Formed at Silicone Oil-Water Interfaces

Impact of Ethylene Oxide Sterilization of Polymer-Based Prefilled Syringes on Chemical Degradation of a Model Therapeutic Protein During Storage

Gelation of a Monoclonal Antibody at the Silicone Oil–Water Interface and Subsequent Rupture of the Interfacial Gel Results in Aggregation and Particle Formation

Conjugation of Emtansine Onto Trastuzumab Promotes Aggregation of the Antibody–Drug Conjugate by Reducing Repulsive Electrostatic Interactions and Increasing Hydrophobic Interactions

Microparticles and Nanoparticles Delivered in Intravenous Saline and in an Intravenous Solution of a Therapeutic Antibody Product

Immunogenicity of aggregates of recombinant human growth hormone in mouse models

Effects of Product Handling Parameters on Particle Levels in a Commercial Factor VIII Product: Impacts and Mitigation

Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution

Silicone oil microdroplets and protein aggregates in repackaged bevacizumab and ranibizumab: effects of long-term storage and product mishandling

Analytical approaches to assess the degradation of therapeutic proteins

Some Lessons Learned From a Comparison Between Sedimentation Velocity Analytical Ultracentrifugation and Size Exclusion Chromatography to Characterize and Quantify Protein Aggregates

The Effects of Excipients on Protein Aggregation During Agitation: An Interfacial Shear Rheology Study

Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation

Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: Essential need to use orthogonal methods to assure the quality of therapeutic protein products

Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals

In Vivo Analysis of the Potency of Silicone Oil Microdroplets as Immunological Adjuvants in Protein Formulations

Effects of Solution Conditions, Processing Parameters, and Container Materials on Aggregation of a Monoclonal Antibody during Freeze-Thawing

Investigation of the Immunogenicity of Different Types of Aggregates of a Murine Monoclonal Antibody in Mice

Effect of the Siliconization Method on Particle Generation in a Monoclonal Antibody Formulation in Pre-filled Syringes

IgG1 Aggregation and Particle Formation Induced by Silicone–water Interfaces on Siliconized Borosilicate Glass Beads: A Model for Siliconized Primary Containers

Ionic Strength Affects Tertiary Structure and Aggregation Propensity of a Monoclonal Antibody Adsorbed to Silicone Oil–Water Interfaces

Response of a concentrated monoclonal antibody formulation to high shear

Understanding and Modulating Opalescence and Viscosity in a Monoclonal Antibody Formulation

Immunogenicity of Structurally Perturbed Hen Egg Lysozyme Adsorbed to Silicone Oil Microdroplets in Wild-Type and Transgenic Mouse Models

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