publication venue for

• Lipid-free, thermostable mRNA vaccines prepared using atomic layer deposition. 2025
• Superior immune responses from thermostable, single-administration rabies vaccines prepared using atomic layer deposition 2025
• Representative training data sets are critical for accurate machine-learning classification of microscopy images of particles formed by lipase-catalyzed polysorbate hydrolysis 2025
• Formulation of three tailed bacteriophages by spray-drying and atomic layer deposition for thermal stability and controlled release 2024
• Stabilization of an Infectious Enveloped Virus by Spray-Drying and Lyophilization 2024
• Stain-Free Approach to Determine and Monitor Cell Heath Using Supervised and Unsupervised Image-Based Deep Learning 2024
• Features in Backgrounds of Microscopy Images Introduce Biases in Machine Learning Analyses 2024
• Interfacial Adsorption Controls Particle Formation in Antibody Formulations Subjected to Extensional Flows and Hydrodynamic Shear 2023
• A Single Dose, Thermostable, Trivalent Human Papillomavirus Vaccine Formulated Using Atomic Layer Deposition 2023
• Lyophilized Filovirus Glycoprotein Vaccines: Peroxides in a Vaccine Formulation with Polysorbate 80-Containing Adjuvant are Associated with Reduced Neutralizing Antibody Titers in Both Mice and Non-Human Primates 2022
• Machine Learning Analysis Provides Insight into Mechanisms of Protein Particle Formation Inside Containers During Mechanical Agitation 2022
• Atomic-Layer Deposition Processes Applied to Phage lambda and a Phage-like Particle Platform Yield Thermostable, Single-Shot Vaccines 2022
• An Interlaboratory Comparison on the Characterization of a Sub-micrometer Polydisperse Particle Dispersion 2022
• Machine learning and accelerated stress approaches to differentiate potential causes of aggregation in polyclonal antibody formulations during shipping 2021
• Preservation of Quaternary Structure in Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search for Stability-Indicating Assays 2020
• Aggregation and Particle Formation During Pumping of an Antibody Formulation Are Controlled by Electrostatic Interactions Between Pump Surfaces and Protein Molecules 2020
• Container Surfaces Control Initiation of Cavitation and Resulting Particle Formation in Protein Formulations After Application of Mechanical Shock 2020
• DEHP Nanodroplets Leached From Polyvinyl Chloride IV Bags Promote Aggregation of IVIG and Activate Complement in Human Serum 2020
• Nanobubbles in Reconstituted Lyophilized Formulations: Interaction With Proteins and Mechanism of Formation 2020
• Subvisible Particles in IVIg Formulations Activate Complement in Human Serum 2020
• Conjugation of Emtansine Onto Trastuzumab Promotes Aggregation of the Antibody-Drug Conjugate by Reducing Repulsive Electrostatic Interactions and Increasing Hydrophobic Interactions 2019
• Rapid Quantification of Protein Particles in High-Concentration Antibody Formulations 2019
• Steric Repulsion Forces Contributed by PEGylation of Interleukin-1 Receptor Antagonist Reduce Gelation and Aggregation at the Silicone Oil-Water Interface 2019
• Postproduction Handling and Administration of Protein Pharmaceuticals and Potential Instability Issues 2018
• Urea Improves Stability of Inactivated Polio Vaccine Serotype 3 During Lyophilization and Storage in Dried Formulations 2018
• Protein Nanoparticles Promote Microparticle Formation in Intravenous Immunoglobulin Solutions During Freeze-Thawing and Agitation Stresses 2018
• Flow Microscopy Imaging Is Sensitive to Characteristics of Subvisible Particles in Peginesatide Formulations Associated With Severe Adverse Reactions 2018
• Deep Convolutional Neural Network Analysis of Flow Imaging Microscopy Data to Classify Subvisible Particles in Protein Formulations 2018
• Immunogenicity of Structurally Perturbed Hen Egg Lysozyme Adsorbed to Silicone Oil Microdroplets in Wild-Type and Transgenic Mouse Models 2017
• Microflow Imaging Analyses Reflect Mechanisms of Aggregate Formation: Comparing Protein Particle Data Sets Using the Kullback-Leibler Divergence 2017
• Particle Formation and Aggregation of a Therapeutic Protein in Nanobubble Suspensions 2016
• Colloidal Instability Fosters Agglomeration of Subvisible Particles Created by Rupture of Gels of a Monoclonal Antibody Formed at Silicone Oil-Water Interfaces 2016
• Reduced Subvisible Particle Formation in Lyophilized Intravenous Immunoglobulin Formulations Containing Polysorbate 20 2016
• Formation of Stable Nanobubbles on Reconstituting Lyophilized Formulations Containing Trehalose 2016
• Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges 2016
• Silicone Oil Microdroplets Can Induce Antibody Responses Against Recombinant Murine Growth Hormone in Mice 2016
• Surfactant Effects on Particle Generation in Antibody Formulations in Pre-filled Syringes 2015
• The Role of Protein Excipient in Driving Antibody Responses to Erythropoietin 2015
• In Vivo Analysis of the Potency of Silicone Oil Microdroplets as Immunological Adjuvants in Protein Formulations 2015
• Analysis of Diffusion-Controlled Dissolution from Polydisperse Collections of Drug Particles with an Assessed Mathematical Model. 2015
• Hydrodynamic Effects on Drug Dissolution and Deaggregation in the Small Intestine-A Study with Felodipine as a Model Drug. 2015
• Dose Levels in Particulate-Containing Formulations Impact Anti-drug Antibody Responses to Murine Monoclonal Antibody in Mice 2015
• Effect of the Siliconization Method on Particle Generation in a Monoclonal Antibody Formulation in Pre-filled Syringes 2015
• 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
• Do Not Drop: Mechanical Shock in Vials Causes Cavitation, Protein Aggregation, and Particle Formation 2015
• Glassy-State Stabilization of a Dominant Negative Inhibitor Anthrax Vaccine Containing Aluminum Hydroxide and Glycopyranoside Lipid A Adjuvants 2015
• The Effect of Protein PEGylation on Physical Stability in Liquid Formulation 2014
• Effects of Phenol and meta-Cresol Depletion on Insulin Analog Stability at Physiological Temperature 2014
• Freezing-Induced Perturbation of Tertiary Structure of a Monoclonal Antibody 2014
• Protein Aggregation and Particle Formation in Prefilled Glass Syringes 2014
• Protein Quantity on the Air-Solid Interface Determines Degradation Rates of Human Growth Hormone in Lyophilized Samples 2014
• Investigations into the Fouling Mechanism of Parvovirus Filters During Filtration of Freeze-Thawed mAb Drug Substance Solutions 2014
• Albinterferon alpha(2b) Adsorption to Silicone Oil-Water Interfaces: Effects on Protein Conformation, Aggregation, and Subvisible Particle Formation 2014
• Antibody Responses in Mice to Particles Formed from Adsorption of a Murine Monoclonal Antibody onto Glass Microparticles 2014
• Preformulation Study of Highly Purified Inactivated Polio Vaccine, Serotype 3 2014
• Recombinant Murine Growth Hormone Particles are More Immunogenic with Intravenous than Subcutaneous Administration 2014
• The effects of excipients on protein aggregation during agitation: An interfacial shear rheology study 2013
• IgG1 aggregation and particle formation induced by silicone-water interfaces on siliconized borosilicate glass beads: A model for siliconized primary containers 2013
• Effects of solution conditions on methionine oxidation in albinterferon alfa-2b and the role of oxidation in its conformation and aggregation 2013
• Ionic strength affects tertiary structure and aggregation propensity of a monoclonal antibody adsorbed to silicone oil-water interfaces 2013
• Excipient effects on humanized monoclonal antibody interactions with silicone oil emulsions 2012
• Particles shed from syringe filters and their effects on agitation-induced protein aggregation 2012
• Physical stability of albinterferon-alpha(2b) in aqueous solution: Effects of conformational stability and colloidal stability on aggregation 2012
• Accelerated Stability Studies of Abatacept Formulations: Comparison of Freeze-Thawing- and Agitation-Induced Stresses 2012
• Selective domain stabilization as a strategy to reduce human serum albumin-human granulocyte colony stimulating factor aggregation rate 2012
• Selective domain stabilization as a strategy to reduce fusion protein aggregation 2012
• The role of adjuvant in mediating antigen structure and stability 2012
• Protein instability and immunogenicity: Roadblocks to clinical application of injectable protein delivery systems for sustained release 2012
• Immunogenicity of recombinant human interferon beta interacting with particles of glass, metal, and polystyrene 2012
• Glass Particles as an Adjuvant: A Model for Adverse Immunogenicity of Therapeutic Proteins 2011
• Effect of Benzyl Alcohol on Recombinant Human Interleukin-1 Receptor Antagonist Structure and Hydrogen-Deuterium Exchange 2011
• Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals 2011
• Aggregation of Recombinant Human Botulinum Protein Antigen Serotype C in Varying Solution Conditions: Implications of Conformational Stability for Aggregation Kinetics 2011
• 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 2011
• Adsorption of Monoclonal Antibodies to Glass Microparticles 2011
• Buffer-Dependent Fragmentation of a Humanized Full-Length Monoclonal Antibody 2010
• 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 2010
• Protein Adsorption and Excipient Effects on Kinetic Stability of Silicone Oil Emulsions 2010
• Inhibition of Agitation-Induced Aggregation of an IgG-Antibody by Hydroxypropyl-β-Cyclodextrin 2010
• Understanding and Modulating Opalescence and Viscosity in a Monoclonal Antibody Formulation 2010
• Evaluation of Chemical Degradation of a Trivalent Recombinant Protein Vaccine Against Botulinum Neurotoxin by LysC Peptide Mapping and MALDI-TOF Mass Spectrometry 2009
• Immunogenicity of Aggregates of Recombinant Human Growth Hormone in Mouse Models 2009
• Mixing Properties of Lyophilized Protein Systems: A Spectroscopic and Calorimetric Study 2009
• Monoclonal Antibody Interactions With Micro- and Nanoparticles: Adsorption, Aggregation, and Accelerated Stress Studies 2009
• Precipitation of a Monoclonal Antibody by Soluble Tungsten 2009
• Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution 2009
• Stability of a Trivalent Recombinant Protein Vaccine Formulation Against Botulinum Neurotoxin During Storage in Aqueous Solution 2009
• Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality 2009
• Common Excipients Impair Detection of Protein Aggregates during Sedimentation Velocity Analytical Ultracentrifugation 2009
• IgG Particle Formation during Filling Pump Operation: A Case Study of Heterogeneous Nucleation on Stainless Steel Nanoparticles 2009
• Influence of Protein Conformation and Adjuvant Aggregation on the Effectiveness of Aluminum Hydroxide Adjuvant in a Model Alkaline Phosphatase Vaccine 2009
• Effect of pH on Stability of Recombinant Botulinum Serotype A Vaccine in Aqueous Solution and During Storage of Freeze-Dried Formulations 2008
• Influence of Particle Size and Antigen Binding on Effectiveness of Aluminum Salt Adjuvants in a Model Lysozyme Vaccine 2008
• High concentration formulations of recombinant human interleukin-1 receptor antagonist: I. Physical characterization 2008
• High concentration formulations of recombinant human interleukin-1 receptor antagonist: II. Aggregation kinetics 2008
• Inhibition of aggregation of aluminum hydroxide adjuvant during freezing and drying 2008
• Effects of solution conditions, processing parameters, and container materials on aggregation of a monoclonal antibody during freeze-thawing 2008
• Characterization of amorphous solids with weak glass transitions using high ramp rate differential scanning calorimetry 2008
• Effects of solution conditions and surface chemistry on the adsorption of three recombinant botulinum neurotoxin antigens to aluminum salt Adjuvants 2007
• Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity 2007
• Effects of pH, temperature, and sucrose on benzyl alcohol-induced aggregation of recombinant human granulocyte colony stimulating factor 2006
• Population balance modeling of aggregation kinetics of recombinant human interleukin-1 receptor antagonist 2005
• Supercritical fluid crystallization of griseofulvin: Crystal habit modification with a selective growth inhibitor 2005
• Effects of Tween 20® and Tween 80® on the stability of albutropin during agitation 2005
• Effects of benzyl alcohol on aggregation of recombinant human interleukin-1-receptor antagonist in reconstituted lyophilized formulations 2005
• Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation 2005
• Mechanism for benzyl alcohol-induced aggregation of recombinant human interleukin-1 receptor antagonist in aqueous solution 2004
• Degradation kinetics of high molecular weight poly (L-lactide) microspheres and release mechanism of lipid:DNA complexes 2004
• Protein-solute interactions affect the outcome of ultrafiltration/diafiltration operations 2004
• Optimizing storage stability of lyophilized recombinant human interleukin-11 with disaccharide/hydroxyethyl starch mixtures 2004
• Effects of annealing lyophilized and spray-lyophilized formulations of recombinant human interferon-γ 2003
• Hydrophobic ion pairing of isoniazid using a prodrug approach 2002
• Surface adsorption of recombinant human interferon-γ in lyophilized and spray-lyophilized formulations 2002
• A new mechanism for decreasing aggregation of recombinant human interferon-γ by a surfactant:: Slowed dissolution of lyophilized formulations in a solution containing 0.03% polysorbate 20 2002
• The effects of tween 20 and sucrose on the stability of anti-L-selectin during lyophilization and reconstitution 2001
• Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T_g′ in pharmaceutical lyophilization 2001
• The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf 2001
• Dry powders of stable protein formulations from aqueous solutions prepared using supercritical CO₂-assisted aerosolization 2001
• Effect of zinc binding and precipitation on structures of recombinant human growth hormone and nerve growth factor 2000
• Optimization of storage stability of lyophilized actin using combinations of disaccharides and dextran 2000
• Photopolymerized, multilaminated matrix devices with optimized nonuniform initial concentration profiles to control drug release 2000
• Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid 1999
• Conformational stability of lyophilized PEGylated proteins in a phase-separating system 1999
• Effect of Tween 20 on freeze-thawing- and agitation-induced aggregation of recombinant, human factor XIII 1998
• Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions 1998
• Aggregation of recombinant human interferon gamma: Kinetics and structural transitions 1998
• Effects of tween 80 and sucrose on acute short-term stability and long-term storage at -20 degrees C of a recombinant hemoglobin 1998
• Preparation and in vitro characterization of gentamycin-impregnated biodegradable beads suitable for treatment of osteomyelitis 1998
• Phase separation of excipients during lyophilization: Effects on protein stability 1997
• Effects of phase separating systems on lyophilized hemoglobin 1996