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List of works by Theodore W Randolph

A new mechanism for decreasing aggregation of recombinant human interferon-gamma by a surfactant: slowed dissolution of lyophilized formulations in a solution containing 0.03% polysorbate 20.

scientific article published on February 2002

Accelerated Stability Studies of Abatacept Formulations: Comparison of Freeze–Thawing- and Agitation-induced Stresses ⬇️

scientific article published on 04 April 2012

Adsorption of monoclonal antibodies to glass microparticles

scientific article

Aggregation of a monoclonal antibody induced by adsorption to stainless steel

scientific article published on January 2010

Aggregation of granulocyte colony stimulating factor under physiological conditions: characterization and thermodynamic inhibition

scientific article

Albinterferon α2b adsorption to silicone oil-water interfaces: effects on protein conformation, aggregation, and subvisible particle formation

scientific article published on 30 December 2013

Antibody responses in mice to particles formed from adsorption of a murine monoclonal antibody onto glass microparticles.

scientific article published on 13 November 2013

BIOTECHNOLOGY: Aggregation of Recombinant Human Botulinum Protein Antigen Serotype C in Varying Solution Conditions: Implications of Conformational Stability for Aggregation Kinetics ⬇️

scientific article published on September 22, 2010

Buffer-dependent fragmentation of a humanized full-length monoclonal antibody

scientific article

Ca2+-surfactant interactions affect enzyme stability in detergent solutions

scientific article published in November 2005

Characterization of amorphous solids with weak glass transitions using high ramp rate differential scanning calorimetry

scientific article published on 01 February 2008

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

scientific article published on 12 July 2016

Common excipients impair detection of protein aggregates during sedimentation velocity analytical ultracentrifugation

scientific article published on January 2009

Congo red populates partially unfolded states of an amyloidogenic protein to enhance aggregation and amyloid fibril formation

scientific article published on 15 January 2003

Degradation kinetics of high molecular weight poly(L-lactide) microspheres and release mechanism of lipid:DNA complexes

scientific article published in October 2004

Dose levels in particulate-containing formulations impact anti-drug antibody responses to murine monoclonal antibody in mice.

scientific article published on 3 March 2015

Effect of pH on stability of recombinant botulinum serotype A vaccine in aqueous solution and during storage of freeze-dried formulations

scientific article published in December 2008

Effect of the siliconization method on particle generation in a monoclonal antibody formulation in pre-filled syringes

scientific article published on 03 March 2015

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

scientific article published in May 2008

Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals ⬇️

scientific article published on April 26, 2011

Effects of benzyl alcohol on aggregation of recombinant human interleukin-1-receptor antagonist in reconstituted lyophilized formulations

scientific article published in February 2005

Effects of pH, temperature, and sucrose on benzyl alcohol-induced aggregation of recombinant human granulocyte colony stimulating factor

scientific article published in July 2006

Effects of phenol and meta-cresol depletion on insulin analog stability at physiological temperature

scientific article published on 6 June 2014

Effects of solutes on solubilization and refolding of proteins from inclusion bodies with high hydrostatic pressure

scientific article published on 29 December 2005

Effects of solution conditions and surface chemistry on the adsorption of three recombinant botulinum neurotoxin antigens to aluminum salt adjuvants

scientific article

Effects of sucrose on conformational equilibria and fluctuations within the native-state ensemble of proteins

scientific article published on June 2003

Evaluation of chemical degradation of a trivalent recombinant protein vaccine against botulinum neurotoxin by LysC peptide mapping and MALDI-TOF mass spectrometry

scientific article

Excipient Effects on Humanized Monoclonal Antibody Interactions with Silicone oil Emulsions ⬇️

scientific article published on September 16, 2012

Flow cytometry: A promising technique for the study of silicone oil-induced particulate formation in protein formulations ⬇️

scientific article published on December 10, 2010

Formation of Stable Nanobubbles on Reconstituting Lyophilized Formulations Containing Trehalose

scientific article published on 8 June 2016

Freezing-induced perturbation of tertiary structure of a monoclonal antibody

scientific article

Glass particles as an adjuvant: A model for adverse immunogenicity of therapeutic proteins ⬇️

scientific article published on June 30, 2011

Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation

scientific article published in February 2005

High concentration formulations of recombinant human interleukin-1 receptor antagonist: II. Aggregation kinetics

scientific article published in August 2008

High-pressure refolding of bikunin: efficacy and thermodynamics

scientific article published in October 2004

High-pressure refolding of disulfide-cross-linked lysozyme aggregates: thermodynamics and optimization

scientific article published in May 2002

High-pressure studies of aggregation of recombinant human interleukin-1 receptor antagonist: thermodynamics, kinetics, and application to accelerated formulation studies

scientific article published on 4 August 2005

High-pressure studies on protein aggregates and amyloid fibrils

scientific article published in January 2006

Hydrophobic ion pairing of isoniazid using a prodrug approach

scientific article

IgG particle formation during filling pump operation: a case study of heterogeneous nucleation on stainless steel nanoparticles

scientific article published on 01 January 2009

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

scientific article published on December 29, 2012

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

scientific article

Immunogenicity of aggregates of recombinant human growth hormone in mouse models

scientific article published on 01 September 2009

Immunogenicity of recombinant human interferon beta interacting with particles of glass, metal, and polystyrene

scientific article published on 14 September 2011

Influence of particle size and antigen binding on effectiveness of aluminum salt adjuvants in a model lysozyme vaccine

scientific article published in December 2008

Influence of protein conformation and adjuvant aggregation on the effectiveness of aluminum hydroxide adjuvant in a model alkaline phosphatase vaccine

scientific article published on January 2009

Inhibition of aggregation of aluminum hydroxide adjuvant during freezing and drying

scientific article published in June 2008

Inhibition of agitation-induced aggregation of an IgG-antibody by hydroxypropyl-beta-cyclodextrin

scientific article published in March 2010

Investigations into the fouling mechanism of parvovirus filters during filtration of freeze-thawed mAb drug substance solutions

scientific article published on 24 January 2014

Kinetics and energetics of assembly, nucleation, and growth of aggregates and fibrils for an amyloidogenic protein. Insights into transition states from pressure, temperature, and co-solute studies

scientific article published on 21 May 2002

Long-term storage of proteins

scientific article published on 01 May 2002

Measurement of the second osmotic virial coefficient for protein solutions exhibiting monomer-dimer equilibrium

scientific article published on 22 March 2008

Mechanism for benzyl alcohol-induced aggregation of recombinant human interleukin-1 receptor antagonist in aqueous solution

scientific article published in December 2004

Mixing properties of lyophilized protein systems: a spectroscopic and calorimetric study

scientific article published in September 2009

Monoclonal antibody interactions with micro- and nanoparticles: adsorption, aggregation, and accelerated stress studies

scientific article published on September 2009

Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges

scientific article published on April 2016

Optimizing storage stability of lyophilized recombinant human interleukin-11 with disaccharide/hydroxyethyl starch mixtures

scientific article published in March 2004

Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality

scientific article published on April 2009

Oxidation of methionine residues in recombinant human interleukin-1 receptor antagonist: implications of conformational stability on protein oxidation kinetics

scientific article published on 5 May 2007

Oxidative dimer formation is the critical rate-limiting step for Parkinson's disease alpha-synuclein fibrillogenesis

scientific article

Particle Formation and Aggregation of a Therapeutic Protein in Nanobubble Suspensions

scientific article published on 31 July 2016

Particles Shed from Syringe Filters and Their Effects on Agitation-Induced Protein Aggregation ⬇️

scientific article published on 06 June 2012

Physical instability of a therapeutic Fc fusion protein: domain contributions to conformational and colloidal stability

scientific article published on December 2009

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

scientific article published on September 1, 2003

Population balance modeling of aggregation kinetics of recombinant human interleukin-1 receptor antagonist

scientific article published in December 2005

Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability Issues

scientific article published on 14 April 2018

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

scientific article published in May 2010

Precipitation of a monoclonal antibody by soluble tungsten

scientific article published on September 2009

Preformulation study of highly purified inactivated polio vaccine, serotype 3.

scientific article

Protein Instability and Immunogenicity: Roadblocks to Clinical Application of Injectable Protein Delivery Systems for Sustained Release ⬇️

scientific article published on December 14, 2011

Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions

scientific article published in April 2010

Protein-protein interactions controlling interfacial aggregation of rhIL-1ra are not described by simple colloid models

scientific article published in February 2018

Protein-solute interactions affect the outcome of ultrafiltration/diafiltration operations

scientific article

Quantification of isoniazid and acetylisoniazid in rat plasma and alveolar macrophages by liquid chromatography-tandem mass spectrometry with on-line extraction

scientific article published on 27 October 2006

Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity

scientific article published in February 2007

Quaternary conformational stability: the effect of reversible self-association on the fibrillation of two insulin analogs

scientific article published on 27 April 2011

Rational design of stable lyophilized protein formulations: theory and practice.

scientific article

Recombinant murine growth hormone particles are more immunogenic with intravenous than subcutaneous administration

scientific article

Reduced Subvisible Particle Formation in Lyophilized Intravenous Immunoglobulin Formulations Containing Polysorbate 20.

scientific article published on 9 June 2016

Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony‐stimulating factor ⬇️

scientific article published on May 1, 2003

Sedimentation velocity analytical ultracentrifugation and SEDFIT/c(s): limits of quantitation for a monoclonal antibody system

scientific article published on 28 November 2006

Selective Domain Stabilization as a Strategy to Reduce Fusion Protein Aggregation ⬇️

scientific article published on January 10, 2012

Selective Domain Stabilization as a Strategy to Reduce Human Serum Albumin–Human Granulocyte Colony Stimulating Factor Aggregation Rate ⬇️

scientific article published on March 15, 2012

Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution

scientific article published on September 2009

Specific volume and adiabatic compressibility measurements of native and aggregated recombinant human interleukin-1 receptor antagonist: density differences enable pressure-modulated refolding

scientific article published in October 2007

Steric repulsion forces contributed by PEGylation of interleukin-1 receptor antagonist (rhIL-1ra) reduce gelation and aggregation at the silicone oil-water interface

article

Subvisible Particle Counting Provides a Sensitive Method of Detecting and Quantifying Aggregation of Monoclonal Antibody Caused by Freeze-Thawing: Insights Into the Roles of Particles in the Protein Aggregation Pathway ⬇️

scientific article published on August 27, 2010

Surface adsorption of recombinant human interferon-gamma in lyophilized and spray-lyophilized formulations

scientific article

Surfactant Effects on Particle Generation in Antibody Formulations in Pre-filled Syringes

scientific article published on 28 September 2015

Surfactant-induced unfolding of cellulase: kinetic studies

scientific article published in January 2006

Temperature dependence of benzyl alcohol- and 8-anilinonaphthalene-1-sulfonate-induced aggregation of recombinant human interleukin-1 receptor antagonist

scientific article published in March 2006

The Role of Protein Excipient in Driving Antibody Responses to Erythropoietin

scientific article published on 16 September 2015

The effects of excipients on protein aggregation during agitation: an interfacial shear rheology study

scientific article published on 27 May 2013

Understanding and modulating opalescence and viscosity in a monoclonal antibody formulation

scientific article published on January 2010

Urea Improves Stability of Inactivated Polio Vaccine Serotype 3 During Lyophilization and Storage in Dried Formulations

scientific article published on 27 April 2018

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