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

[1]  M. Borkovec,et al.  Interaction Forces and Aggregation Rates of Colloidal Latex Particles in the Presence of Monovalent Counterions. , 2015, The journal of physical chemistry. B.

[2]  Jared S. Bee,et al.  Gelation of a monoclonal antibody at the silicone oil-water interface and subsequent rupture of the interfacial gel results in aggregation and particle formation. , 2015, Journal of pharmaceutical sciences.

[3]  M. Morbidelli,et al.  Kinetics and cluster morphology evolution of shear-driven aggregation of well-stabilized colloids. , 2015, Langmuir : the ACS journal of surfaces and colloids.

[4]  Malgorzata B. Tracka,et al.  The role of electrostatics in protein-protein interactions of a monoclonal antibody. , 2014, Molecular pharmaceutics.

[5]  Theodore W Randolph,et al.  Protein aggregation and particle formation in prefilled glass syringes. , 2014, Journal of pharmaceutical sciences.

[6]  Jared S. Bee,et al.  Partial unfolding of a monoclonal antibody: role of a single domain in driving protein aggregation. , 2014, Biochemistry.

[7]  Vincenzo Martorana,et al.  Protein–Protein Interactions in Dilute to Concentrated Solutions: α-Chymotrypsinogen in Acidic Conditions , 2014, The journal of physical chemistry. B.

[8]  M. Borkovec,et al.  Predicting aggregation rates of colloidal particles from direct force measurements. , 2013, The journal of physical chemistry. B.

[9]  Theodore W Randolph,et al.  The effects of excipients on protein aggregation during agitation: an interfacial shear rheology study. , 2013, Journal of pharmaceutical sciences.

[10]  W. Jiskoot,et al.  Micro-flow imaging and resonant mass measurement (Archimedes)--complementary methods to quantitatively differentiate protein particles and silicone oil droplets. , 2013, Journal of pharmaceutical sciences.

[11]  A. D. Nielsen,et al.  Viscosity of high concentration protein formulations of monoclonal antibodies of the IgG1 and IgG4 subclass - prediction of viscosity through protein-protein interaction measurements. , 2013, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[12]  J. Ježek,et al.  Biopharmaceutical formulations for pre-filled delivery devices , 2013, Expert opinion on drug delivery.

[13]  Theodore W Randolph,et al.  IgG1 aggregation and particle formation induced by silicone-water interfaces on siliconized borosilicate glass beads: a model for siliconized primary containers. , 2013, Journal of pharmaceutical sciences.

[14]  Jared S. Bee,et al.  Ionic strength affects tertiary structure and aggregation propensity of a monoclonal antibody adsorbed to silicone oil-water interfaces. , 2013, Journal of pharmaceutical sciences.

[15]  K. Fukui,et al.  Effects of Ionic Strength and Sugars on the Aggregation Propensity of Monoclonal Antibodies: Influence of Colloidal and Conformational Stabilities , 2013, Pharmaceutical Research.

[16]  Theodore W Randolph,et al.  Excipient effects on humanized monoclonal antibody interactions with silicone oil emulsions. , 2012, Journal of pharmaceutical sciences.

[17]  R. Mezzenga,et al.  Simultaneous control of pH and ionic strength during interfacial rheology of β-lactoglobulin fibrils adsorbed at liquid/liquid Interfaces. , 2012, Langmuir : the ACS journal of surfaces and colloids.

[18]  Theodore W Randolph,et al.  Physical stability of albinterferon-α(2b) in aqueous solution: effects of conformational stability and colloidal stability on aggregation. , 2012, Journal of pharmaceutical sciences.

[19]  Sergii Rudiuk,et al.  Importance of the dynamics of adsorption and of a transient interfacial stress on the formation of aggregates of IgG antibodies , 2012 .

[20]  Karsten Mäder,et al.  Assessment of net charge and protein-protein interactions of different monoclonal antibodies. , 2011, Journal of pharmaceutical sciences.

[21]  Christopher J Roberts,et al.  Nonnative aggregation of an IgG1 antibody in acidic conditions: part 1. Unfolding, colloidal interactions, and formation of high-molecular-weight aggregates. , 2011, Journal of pharmaceutical sciences.

[22]  P. Wilde,et al.  Effect of gastric conditions on β-lactoglobulin interfacial networks: influence of the oil phase on protein structure. , 2010, Langmuir : the ACS journal of surfaces and colloids.

[23]  Theodore W Randolph,et al.  Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. , 2010, Journal of pharmaceutical sciences.

[24]  B. Ogunnaike,et al.  Multi-variate approach to global protein aggregation behavior and kinetics: effects of pH, NaCl, and temperature for alpha-chymotrypsinogen A. , 2010, Journal of pharmaceutical sciences.

[25]  Theodore W Randolph,et al.  Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. , 2009, Journal of pharmaceutical sciences.

[26]  D. Wuttke,et al.  High concentration formulations of recombinant human interleukin-1 receptor antagonist: I. Physical characterization. , 2008, Journal of pharmaceutical sciences.

[27]  Nitin Rathore,et al.  Current Perspectives on Stability of Protein Drug Products during Formulation, Fill and Finish Operations , 2008, Biotechnology progress.

[28]  C. R. Middaugh,et al.  Silicone oil induced aggregation of proteins. , 2005, Journal of pharmaceutical sciences.

[29]  Igor Polikarpov,et al.  Average protein density is a molecular‐weight‐dependent function , 2004, Protein science : a publication of the Protein Society.

[30]  Theodore W Randolph,et al.  Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony‐stimulating factor , 2003, Protein science : a publication of the Protein Society.

[31]  Grigor B. Bantchev,et al.  Surface Shear Rheology of β-Casein Layers at the Air/Solution Interface: Formation of a Two-Dimensional Physical Gel , 2003 .

[32]  John F. Carpenter,et al.  Physical Stability of Proteins in Aqueous Solution: Mechanism and Driving Forces in Nonnative Protein Aggregation , 2003, Pharmaceutical Research.

[33]  J. Prausnitz,et al.  Protein-protein interactions in concentrated electrolyte solutions: Hofmeister-series effects , 2002 .

[34]  C. Kruif,et al.  Stability of casein micelles in milk , 2002 .

[35]  Vladimiros Nikolakis,et al.  Zeolite Growth by Addition of Subcolloidal Particles: Modeling and Experimental Validation , 2000 .

[36]  Curtis W. Frank,et al.  An Interfacial Stress Rheometer To Study Rheological Transitions in Monolayers at the Air-Water Interface , 1999 .

[37]  P. Wyatt Light scattering and the absolute characterization of macromolecules , 1993 .

[38]  J. Fuller European Community Concerted Action Programme in Diabetes (EURODIAB) , 1989, Diabetic medicine : a journal of the British Diabetic Association.

[39]  A. Rosenberg,et al.  A risk-based approach to immunogenicity concerns of therapeutic protein product, Pat III , 2004 .

[40]  Douglas W. Fuerstenau,et al.  Mutual coagulation of colloidal dispersions , 1966 .