Publications in VIVO

Co-author Network

Randolph, Theodore W The Kenneth L. and Genevieve G. Gillespie Professor in Bioengineering

Positions

Professor, Chemical and Biological Engineering
Endowed/Named Professor, College of Engineering and Applied Science

Research Areas

Research

research overview

Dr. Randolph's research is focused on the stabilization and delivery of protein-based therapeutics and vaccines.

keywords

protein stabilization, vaccine development, drug delivery

Publications

selected publications

chapter
journal article
- Protein-protein interactions controlling interfacial aggregation of rhIL-1ra are not described by simple colloid models. Protein Science. 1191-1204. 2018
- Flow Microscopy Imaging Is Sensitive to Characteristics of Subvisible Particles in Peginesatide Formulations Associated With Severe Adverse Reactions. Journal of Pharmaceutical Sciences. 1313-1321. 2018
- Deep Convolutional Neural Network Analysis of Flow Imaging Microscopy Data to Classify Subvisible Particles in Protein Formulations. Journal of Pharmaceutical Sciences. 999-1008. 2018
- Response to Comment to the Editor. Biophysical Journal. 755-756. 2017
- Immunogenicity of Structurally Perturbed Hen Egg Lysozyme Adsorbed to Silicone Oil Microdroplets in Wild-Type and Transgenic Mouse Models. Journal of Pharmaceutical Sciences. 1519-1527. 2017
- Microflow Imaging Analyses Reflect Mechanisms of Aggregate Formation: Comparing Protein Particle Data Sets Using the Kullback-Leibler Divergence. Journal of Pharmaceutical Sciences. 1239-1248. 2017
- Aggregation of amphipathic peptides at an aqueous-organic interface using coarse-grained simulations. Molecular Simulation. 1448-1458. 2017
- Challenges in Predicting Protein-Protein Interactions from Measurements of Molecular Diffusivity. Biophysical Journal. 1831-1842. 2016
- Particle Formation and Aggregation of a Therapeutic Protein in Nanobubble Suspensions. Journal of Pharmaceutical Sciences. 3057-3063. 2016
- 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. 2338-2348. 2016
- Reduced Subvisible Particle Formation in Lyophilized Intravenous Immunoglobulin Formulations Containing Polysorbate 20. Journal of Pharmaceutical Sciences. 2302-2309. 2016
- Formation of Stable Nanobubbles on Reconstituting Lyophilized Formulations Containing Trehalose. Journal of Pharmaceutical Sciences. 2249-2253. 2016
- Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges. Journal of Pharmaceutical Sciences. 1567-1575. 2016
- Silicone Oil Microdroplets Can Induce Antibody Responses Against Recombinant Murine Growth Hormone in Mice. Journal of Pharmaceutical Sciences. 1623-1632. 2016
- Surfactant Effects on Particle Generation in Antibody Formulations in Pre-filled Syringes. Journal of Pharmaceutical Sciences. 4056-4064. 2015
- The Role of Protein Excipient in Driving Antibody Responses to Erythropoietin. Journal of Pharmaceutical Sciences. 4041-4055. 2015
- In Vivo Analysis of the Potency of Silicone Oil Microdroplets as Immunological Adjuvants in Protein Formulations. Journal of Pharmaceutical Sciences. 3681-3690. 2015
- Development of a highly thermostable, adjuvanted human papillomavirus vaccine. European Journal of Pharmaceutics and Biopharmaceutics. 220-228. 2015
- Electrostatic Interactions Influence Protein Adsorption (but Not Desorption) at the Silica-Aqueous Interface. Journal of Physical Chemistry Letters. 2583-2587. 2015
- Molecular Trajectories Provide Signatures of Protein Clustering and Crowding at the Oil/Water Interface. Langmuir. 5882-5890. 2015
- Dose Levels in Particulate-Containing Formulations Impact Anti-drug Antibody Responses to Murine Monoclonal Antibody in Mice. Journal of Pharmaceutical Sciences. 1610-1621. 2015
- Effect of the Siliconization Method on Particle Generation in a Monoclonal Antibody Formulation in Pre-filled Syringes. Journal of Pharmaceutical Sciences. 1601-1609. 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. Journal of Pharmaceutical Sciences. 1282-1290. 2015
- Do Not Drop: Mechanical Shock in Vials Causes Cavitation, Protein Aggregation, and Particle Formation. Journal of Pharmaceutical Sciences. 602-611. 2015
- Glassy-State Stabilization of a Dominant Negative Inhibitor Anthrax Vaccine Containing Aluminum Hydroxide and Glycopyranoside Lipid A Adjuvants. Journal of Pharmaceutical Sciences. 627-639. 2015
- Investigation of the Immunogenicity of Different Types of Aggregates of a Murine Monoclonal Antibody in Mice. Pharmaceutical Research. 430-444. 2015
- Storage stability of keratinocyte growth factor-2 in lyophilized formulations: Effects of formulation physical properties and protein fraction at the solid-air interface. European Journal of Pharmaceutics and Biopharmaceutics. 332-341. 2014
- The Effect of Protein PEGylation on Physical Stability in Liquid Formulation. Journal of Pharmaceutical Sciences. 3043-3054. 2014
- Effects of Phenol and meta-Cresol Depletion on Insulin Analog Stability at Physiological Temperature. Journal of Pharmaceutical Sciences. 2255-2267. 2014
- Freezing-Induced Perturbation of Tertiary Structure of a Monoclonal Antibody. Journal of Pharmaceutical Sciences. 1979-1986. 2014
- UV photodegradation of murine growth hormone: Chemical analysis and immunogenicity consequences. European Journal of Pharmaceutics and Biopharmaceutics. 395-402. 2014
- Protein Aggregation and Particle Formation in Prefilled Glass Syringes. Journal of Pharmaceutical Sciences. 1601-1612. 2014
- Partial Unfolding of a Monoclonal Antibody: Role of a Single Domain in Driving Protein Aggregation. Biochemistry. 3367-3377. 2014
- Protein Quantity on the Air-Solid Interface Determines Degradation Rates of Human Growth Hormone in Lyophilized Samples. Journal of Pharmaceutical Sciences. 1356-1366. 2014
- Investigations into the Fouling Mechanism of Parvovirus Filters During Filtration of Freeze-Thawed mAb Drug Substance Solutions. Journal of Pharmaceutical Sciences. 890-899. 2014
- Albinterferon alpha(2b) Adsorption to Silicone Oil-Water Interfaces: Effects on Protein Conformation, Aggregation, and Subvisible Particle Formation. Journal of Pharmaceutical Sciences. 427-436. 2014
- Antibody Responses in Mice to Particles Formed from Adsorption of a Murine Monoclonal Antibody onto Glass Microparticles. Journal of Pharmaceutical Sciences. 78-89. 2014
- Preformulation Study of Highly Purified Inactivated Polio Vaccine, Serotype 3. Journal of Pharmaceutical Sciences. 140-151. 2014
- Recombinant Murine Growth Hormone Particles are More Immunogenic with Intravenous than Subcutaneous Administration. Journal of Pharmaceutical Sciences. 128-139. 2014
- Impact of heat treatment on miscibility of proteins and disaccharides in frozen solutions. European Journal of Pharmaceutics and Biopharmaceutics. 177-183. 2013
- Lyophilization of a triply unsaturated phospholipid: Effects of trace metal contaminants. European Journal of Pharmaceutics and Biopharmaceutics. 306-313. 2013
- Stabilization of a recombinant ricin toxin A subunit vaccine through lyophilization. European Journal of Pharmaceutics and Biopharmaceutics. 279-286. 2013
- The effects of excipients on protein aggregation during agitation: An interfacial shear rheology study. Journal of Pharmaceutical Sciences. 2460-2470. 2013
- 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. 852-865. 2013
- Effects of solution conditions on methionine oxidation in albinterferon alfa-2b and the role of oxidation in its conformation and aggregation. Journal of Pharmaceutical Sciences. 660-673. 2013
- Ionic strength affects tertiary structure and aggregation propensity of a monoclonal antibody adsorbed to silicone oil-water interfaces. Journal of Pharmaceutical Sciences. 429-440. 2013
- Contributions of local mobility and degree of retention of native secondary structure to the stability of recombinant human growth hormone (rhGH) in glassy lyophilized formulations. Soft Matter. 7855-7865. 2013
- Excipient effects on humanized monoclonal antibody interactions with silicone oil emulsions. Journal of Pharmaceutical Sciences. 4419-4432. 2012
- Particles shed from syringe filters and their effects on agitation-induced protein aggregation. Journal of Pharmaceutical Sciences. 2952-2959. 2012
- Physical stability of albinterferon-alpha(2b) in aqueous solution: Effects of conformational stability and colloidal stability on aggregation. Journal of Pharmaceutical Sciences. 2702-2719. 2012
- Accelerated Stability Studies of Abatacept Formulations: Comparison of Freeze-Thawing- and Agitation-Induced Stresses. Journal of Pharmaceutical Sciences. 2307-2315. 2012
- Selective domain stabilization as a strategy to reduce human serum albumin-human granulocyte colony stimulating factor aggregation rate. Journal of Pharmaceutical Sciences. 2009-2016. 2012
- Selective domain stabilization as a strategy to reduce fusion protein aggregation. Journal of Pharmaceutical Sciences. 1400-1409. 2012
- Protein instability and immunogenicity: Roadblocks to clinical application of injectable protein delivery systems for sustained release. Journal of Pharmaceutical Sciences. 946-954. 2012
- Immunogenicity of recombinant human interferon beta interacting with particles of glass, metal, and polystyrene. Journal of Pharmaceutical Sciences. 187-199. 2012
- Production of particles of therapeutic proteins at the air-water interface during compression/dilation cycles. Soft Matter. 10329-10335. 2012
- The two faces of His-tag: Immune response versus ease of protein purification. Biotechnology Journal. 18-19. 2012
- Glass Particles as an Adjuvant: A Model for Adverse Immunogenicity of Therapeutic Proteins. Journal of Pharmaceutical Sciences. 4953-4964. 2011
- Effect of Benzyl Alcohol on Recombinant Human Interleukin-1 Receptor Antagonist Structure and Hydrogen-Deuterium Exchange. Journal of Pharmaceutical Sciences. 4215-4224. 2011
- Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals. Journal of Pharmaceutical Sciences. 4158-4170. 2011
- Quaternary Conformational Stability: The Effect of Reversible Self-Association on the Fibrillation of Two Insulin Analogs. Biotechnology and Bioengineering. 2359-2370. 2011
- Non-oxime pyrazole based inhibitors of B-Raf kinase. Bioorganic and Medicinal Chemistry Letters. 3488-3492. 2011
- Pyrazolopyridine Inhibitors of B-Raf(V600E). Part 1: The Development of Selective, Orally Bioavailable, and Efficacious Inhibitors. ACS Medicinal Chemistry Letters. 342-347. 2011
- Flow cytometry: A promising technique for the study of silicone oil-induced particulate formation in protein formulations. Analytical Biochemistry. 191-199. 2011
- Aggregation of Recombinant Human Botulinum Protein Antigen Serotype C in Varying Solution Conditions: Implications of Conformational Stability for Aggregation Kinetics. Journal of Pharmaceutical Sciences. 836-848. 2011
- The Discovery of furo[2,3-c]pyridine-based indanone oximes as potent and selective B-Raf inhibitors. Bioorganic and Medicinal Chemistry Letters. 1248-1252. 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. Journal of Pharmaceutical Sciences. 492-503. 2011
- Adsorption of Monoclonal Antibodies to Glass Microparticles. Journal of Pharmaceutical Sciences. 123-132. 2011
- Crystallization of Recombinant Human Growth Hormone at Elevated Pressures: Pressure Effects on PEG-Induced Volume Exclusion Interactions. Biotechnology and Bioengineering. 663-672. 2010
- Buffer-Dependent Fragmentation of a Humanized Full-Length Monoclonal Antibody. Journal of Pharmaceutical Sciences. 2962-2974. 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. Journal of Pharmaceutical Sciences. 2200-2208. 2010
- Recombinant Murine Growth Hormone from E. coli Inclusion Bodies: Expression, High-Pressure Solubilization and Refolding, and Characterization of Activity and Structure. Biotechnology Progress. 743-749. 2010
- Protein Adsorption and Excipient Effects on Kinetic Stability of Silicone Oil Emulsions. Journal of Pharmaceutical Sciences. 1721-1733. 2010
- Inhibition of Agitation-Induced Aggregation of an IgG-Antibody by Hydroxypropyl-beta-Cyclodextrin. Journal of Pharmaceutical Sciences. 1193-1206. 2010
- Aggregation of a Monoclonal Antibody Induced by Adsorption to Stainless Steel. Biotechnology and Bioengineering. 121-129. 2010
- Understanding and Modulating Opalescence and Viscosity in a Monoclonal Antibody Formulation. Journal of Pharmaceutical Sciences. 82-93. 2010
- Physical Instability of a Therapeutic Fc Fusion Protein: Domain Contributions to Conformational and Colloidal Stability. Biochemistry. 11724-11736. 2009
- Evaluation of Chemical Degradation of a Trivalent Recombinant Protein Vaccine Against Botulinum Neurotoxin by LysC Peptide Mapping and MALDI-TOF Mass Spectrometry. Journal of Pharmaceutical Sciences. 2994-3012. 2009
- Immunogenicity of Aggregates of Recombinant Human Growth Hormone in Mouse Models. Journal of Pharmaceutical Sciences. 3247-3264. 2009
- Mixing Properties of Lyophilized Protein Systems: A Spectroscopic and Calorimetric Study. Journal of Pharmaceutical Sciences. 2954-2969. 2009
- Monoclonal Antibody Interactions With Micro- and Nanoparticles: Adsorption, Aggregation, and Accelerated Stress Studies. Journal of Pharmaceutical Sciences. 3218-3238. 2009
- Precipitation of a Monoclonal Antibody by Soluble Tungsten. Journal of Pharmaceutical Sciences. 3290-3301. 2009
- Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution. Journal of Pharmaceutical Sciences. 3167-3181. 2009
- Stability of a Trivalent Recombinant Protein Vaccine Formulation Against Botulinum Neurotoxin During Storage in Aqueous Solution. Journal of Pharmaceutical Sciences. 2970-2993. 2009
- Response of a Concentrated Monoclonal Antibody Formulation to High Shear. Biotechnology and Bioengineering. 936-943. 2009
- Role of electrostatic repulsion on colloidal stability of Bacillus halmapalus alpha-amylase. BBA - Proteins and Proteomics. 1058-1065. 2009
- Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality. Journal of Pharmaceutical Sciences. 1201-1205. 2009
- Aggregation and stability characterization of abatacept (orencia), a therapeutic fusion protein. ACS National Meeting Book of Abstracts. 607-607. 2009
- Refolding of Proteins From Inclusion Bodies Is Favored by a Diminished Hydrophobic Effect at Elevated Pressures. Biotechnology and Bioengineering. 483-492. 2009
- Common Excipients Impair Detection of Protein Aggregates during Sedimentation Velocity Analytical Ultracentrifugation. Journal of Pharmaceutical Sciences. 50-62. 2009
- IgG Particle Formation during Filling Pump Operation: A Case Study of Heterogeneous Nucleation on Stainless Steel Nanoparticles. Journal of Pharmaceutical Sciences. 94-104. 2009
- Influence of Protein Conformation and Adjuvant Aggregation on the Effectiveness of Aluminum Hydroxide Adjuvant in a Model Alkaline Phosphatase Vaccine. Journal of Pharmaceutical Sciences. 114-121. 2009
- Measurement of the second osmotic virial coefficient for protein solutions exhibiting monomer-dimer equilibrium (vol 377, pg 128, 2008). Analytical Biochemistry. 349-349. 2008
- Effect of pH on Stability of Recombinant Botulinum Serotype A Vaccine in Aqueous Solution and During Storage of Freeze-Dried Formulations. Journal of Pharmaceutical Sciences. 5132-5146. 2008
- Influence of Particle Size and Antigen Binding on Effectiveness of Aluminum Salt Adjuvants in a Model Lysozyme Vaccine. Journal of Pharmaceutical Sciences. 5252-5262. 2008
- BIOT 249-Lyophilized, adjuvanted vaccines: Processing effects on particle size, protein stability, protein adsorption and efficacy. ACS National Meeting Book of Abstracts. 2008
- BIOT 29-Opalescence in antibody formulations is a solution critical phenomenon. ACS National Meeting Book of Abstracts. 2008
- BIOT 32-Buffer-dependent fragmentation of a humanized full-length monoclonal antibody. ACS National Meeting Book of Abstracts. 2008
- BIOT 338-High hydrostatic pressures as a tool to recover folded protein from aggregates and inclusion bodies. ACS National Meeting Book of Abstracts. 2008
- BIOT 94-Interactions of an IgG1 with siliconized glass beads. ACS National Meeting Book of Abstracts. 2008
- BIOT 95-The interaction of a monoclonal antibody with stainless steel, cellulose, glass, and tungsten. ACS National Meeting Book of Abstracts. 2008
- Potent and selective pyrazole-based inhibitors of B-Raf kinase. Bioorganic and Medicinal Chemistry Letters. 4692-4695. 2008
- High concentration formulations of recombinant human interleukin-1 receptor antagonist: I. Physical characterization. Journal of Pharmaceutical Sciences. 3035-3050. 2008
- High concentration formulations of recombinant human interleukin-1 receptor antagonist: II. Aggregation kinetics. Journal of Pharmaceutical Sciences. 3005-3021. 2008
- Measurement of the second osmotic virial coefficient for protein solutions exhibiting monomer-dimer equilibrium. Analytical Biochemistry. 128-133. 2008
- Inhibition of aggregation of aluminum hydroxide adjuvant during freezing and drying. Journal of Pharmaceutical Sciences. 2051-2061. 2008
- Effects of solution conditions, processing parameters, and container materials on aggregation of a monoclonal antibody during freeze-thawing. Journal of Pharmaceutical Sciences. 1801-1812. 2008
- Characterization of amorphous solids with weak glass transitions using high ramp rate differential scanning calorimetry. Journal of Pharmaceutical Sciences. 1013-1024. 2008
- Specific volume and adiabatic compressibility measurements of native and aggregated recombinant human interleukin-1 receptor antagonist: Density differences enable pressure-modulated refolding. Biotechnology and Bioengineering. 476-485. 2007
- Effects of solution conditions and surface chemistry on the adsorption of three recombinant botulinum neurotoxin antigens to aluminum salt Adjuvants. Journal of Pharmaceutical Sciences. 2375-2389. 2007
- BIOT 10-Aggregation of a monoclonal antibody induced by adsorption to microparticle surfaces. ACS National Meeting Book of Abstracts. 2007
- BIOT 227-Silicone oil contamination of therapeutic protein formulations: Surfactant and protein effects. ACS National Meeting Book of Abstracts. 2007
- BIOT 230-Discrepancies in the phase behaviors of therapeutic antibodies. ACS National Meeting Book of Abstracts. 2007
- Engineering challenges of protein formulations. AIChE Journal. 1902-1907. 2007
- Influence of hydrostatic pressure and cosolutes on RNA tertiary structure. Journal of the American Chemical Society. 9290-+. 2007
- Oxidation of methionine residues in recombinant human interleukin-1 receptor antagonist: Implications of conformational stability on protein oxidation kinetics. Biochemistry. 6213-6224. 2007
- Quantification of isoniazid and acetylisoniazid in rat plasma and alveolar macrophages by liquid chromatography-tandem mass spectrometry with on-line extraction. Journal of chromatography. B, Biomedical sciences and applications. 188-198. 2007
- Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity. Journal of Pharmaceutical Sciences. 268-279. 2007
- Sedimentation velocity analytical ultracentrifugation and SEDFIT/c(s): Limits of quantitation for a monoclonal antibody system. Analytical Biochemistry. 24-30. 2007
- Effects of pH, temperature, and sucrose on benzyl alcohol-induced aggregation of recombinant human granulocyte colony stimulating factor. Journal of Pharmaceutical Sciences. 1480-1497. 2006
- Scale-up criteria for an injector with a confined mixing chamber during precipitation with a compressed-fluid antisolvent. Journal of Supercritical Fluids. 242-253. 2006
- Temperature dependence of benzyl alcohol- and 8-anilinonaphthalene-1-sulfonate-induced aggregation of recombinant human interleukin-1 receptor antagonist. Biochemistry. 3898-3911. 2006
- Effects of solutes on solubilization and refolding of proteins from inclusion bodies with high hydrostatic pressure. Protein Science. 304-313. 2006
- High-pressure studies on protein aggregates and amyloid fibrils. Methods in Enzymology. 237-253. 2006
- Surfactant-induced unfolding of cellulase: Kinetic studies. Biotechnology Progress. 225-232. 2006
- Population balance modeling of aggregation kinetics of recombinant human interleukin-1 receptor antagonist. Journal of Pharmaceutical Sciences. 2735-2748. 2005
- Supercritical fluid crystallization of griseofulvin: Crystal habit modification with a selective growth inhibitor. Journal of Pharmaceutical Sciences. 2688-2702. 2005
- Ca2+-surfactant interactions affect enzyme stability in detergent solutions. Biotechnology Progress. 1716-1723. 2005
- Microparticle-based lung delivery of INH decreases INH metabolism and targets alveolar macrophages. Journal of Controlled Release. 288-299. 2005
- High-pressure studies of aggregation of recombinant human interleukin-1 receptor antagonist: Thermodynamics, kinetics, and application to accelerated formulation studies. Protein Science. 2258-2266. 2005
- Propagation and termination kinetics of cross-linking photopolymerizations studied using electron paramagnetic resonance spectroscopy in conjunction with near IR spectroscopy. Macromolecules. 6954-6964. 2005
- Effects of Tween 20 (R) and Tween 80 (R) on the stability of albutropin during agitation. Journal of Pharmaceutical Sciences. 1368-1381. 2005
- High-Hydrostatic pressure refolding of proteins. Genetic Engineering News. 46-47. 2005
- Effects of benzyl alcohol on aggregation of recombinant human interleukin-1-receptor antagonist in reconstituted lyophilized formulations. Journal of Pharmaceutical Sciences. 382-396. 2005
- Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation. Journal of Pharmaceutical Sciences. 256-274. 2005
- Mechanism for benzyl alcohol-induced aggregation of recombinant human interleukin-1 receptor antagonist in aqueous solution. Journal of Pharmaceutical Sciences. 3076-3089. 2004
- Degradation kinetics of high molecular weight poly (L-lactide) microspheres and release mechanism of lipid : DNA complexes. Journal of Pharmaceutical Sciences. 2573-2584. 2004
- High-pressure refolding of bikunin: Efficacy and thermodynamics. Protein Science. 2639-2650. 2004
- Protein-solute interactions affect the outcome of ultrafiltration/diafiltration operations. Journal of Pharmaceutical Sciences. 2332-2342. 2004
- Nucleation and growth rates of poly(L-lactic acid) microparticles during precipitation with a compressed-fluid antisolvent. Langmuir. 7254-7264. 2004
- Protein-solute interactions affect the outcome of ultrafiltration/diafiltration operations. Protein Science. 54-54. 2004
- Reversal of protein aggregation under high hydrostatic pressures.. ACS National Meeting Book of Abstracts. U214-U214. 2004
- Optimizing storage stability of lyophilized recombinant human interleukin-11 with disaccharide/hydroxyethyl starch mixtures. Journal of Pharmaceutical Sciences. 684-696. 2004
- Protease autolysis in heavy-duty liquid detergent formulations: effects of thermodynamic stabilizers and protease inhibitors. Enzyme and Microbial Technology. 114-125. 2004
- Manipulation of particle size distribution of poly(L-lactic acid) nanoparticles with a jet-swirl nozzle during precipitation with a compressed antisolvent. Journal of Supercritical Fluids. 317-336. 2003
- In vitro and in vivo evaluation of the effects of PLA microparticle crystallinity on cellular response. Journal of Controlled Release. 147-161. 2003
- Effect of calcium-micelle interactions on subtilisin stability in surfactant solutions.. ACS National Meeting Book of Abstracts. U372-U372. 2003
- High pressure refolding of bikunin protein aggregates - Efficacy and thermodynamics.. ACS National Meeting Book of Abstracts. U186-U186. 2003
- Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation. Pharmaceutical Research. 1325-1336. 2003
- Pressure-induced aggregation of interleukin-1 receptor antagonist (IL-1RA) - Mechanism and thermodynamics.. ACS National Meeting Book of Abstracts. U175-U175. 2003
- High-pressure refolding of bikunin protein aggregates: efficacy and thermodynamics.. Biochemistry. 8643-8643. 2003
- Pressure-induced aggregation of interleukin-1 receptor antagonist (IL-1ra): mechanism and thermodynamics. Biochemistry. 8628-8629. 2003
- Effects of sucrose on conformational equilibria and fluctuations within the native-state ensemble of proteins. Protein Science. 1252-1261. 2003
- Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony-stimulating factor. Protein Science. 903-913. 2003
- Mechanism of microparticle formation in the compressed antisolvent precipitation and photopolymerization (CAPP) process. Langmuir. 3926-3934. 2003
- Effects of annealing lyophilized and spray-lyophilized formulations of recombinant human interferon-gamma. Journal of Pharmaceutical Sciences. 715-729. 2003
- Congo red populates partially unfolded states of an amyloidogenic protein to enhance aggregation and amyloid fibril formation. Journal of Biological Chemistry. 10842-10850. 2003
- Using EPR spectroscopy in conjunction with FT-NIR spectroscopy to study crosslinking photopolymerization kinetics.. ACS National Meeting Book of Abstracts. U680-U680. 2003
- Oxidative dimer formation is the critical rate-limiting step for Parkinson's disease alpha-synuclein fibrillogenesis. Biochemistry. 829-837. 2003
- Computer simulation of convective and diffusive transport of controlled-release drugs in the vitreous humor. Pharmaceutical Research. 96-102. 2003
- Effects of drying methods and additives on the structure, function, and storage stability of subtilisin: role of protein conformation and molecular mobility. Enzyme and Microbial Technology. 765-774. 2002
- Dissolution and partitioning behavior of hydrophobic ion-paired compounds. Pharmaceutical Research. 1572-1576. 2002
- Protein aggregation at interfaces formed during lyophilization.. ACS National Meeting Book of Abstracts. U226-U226. 2002
- Protein aggregation-conformational stability and colloidal stability.. ACS National Meeting Book of Abstracts. U225-U225. 2002
- Protein refolding at high hydrostatic pressure.. ACS National Meeting Book of Abstracts. U229-U229. 2002
- 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. Journal of Biological Chemistry. 27240-27246. 2002
- Hydrophobic ion pairing of isoniazid using a prodrug approach. Journal of Pharmaceutical Sciences. 1502-1511. 2002
- Surface adsorption of recombinant human interferon-gamma in lyophilized and spray-lyophilized formulations. Journal of Pharmaceutical Sciences. 1474-1487. 2002
- Aggregation of granulocyte colony stimulating factor under physiological conditions: Characterization and thermodynamic inhibition. Biochemistry. 6422-6431. 2002
- Compressed antisolvent precipitation and photopolymerization to form highly cross-linked polymer particles. Macromolecules. 4289-4296. 2002
- High-pressure refolding of disulfide-cross-linked lysozyme aggregates: Thermodynamics and optimization. Biotechnology Progress. 565-571. 2002
- High hydrostatic pressure as a tool to study protein aggregation and amyloidosis. BBA - Proteins and Proteomics. 224-234. 2002
- 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. Journal of Pharmaceutical Sciences. 543-558. 2002
- Surfactant-protein interactions.. Pharmaceutical Biotechnology -New York-. 159-175. 2002
- High pressure refolding of recombinant human growth hormone from insoluble aggregates - Structural transformations, kinetic barriers, and energetics. Journal of Biological Chemistry. 46856-46863. 2001
- Electrochemical determination of dissolution rates of lyophilized pharmaceutical formulations. Analytical Chemistry. 5296-5301. 2001
- The effects of tween 20 and sucrose on the stability of anti-L-selectin during lyophilization and reconstitution. Journal of Pharmaceutical Sciences. 1466-1477. 2001
- Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T-g ' in pharmaceutical lyophilization. Journal of Pharmaceutical Sciences. 872-887. 2001
- The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf. Journal of Pharmaceutical Sciences. 860-871. 2001
- Partial molar volume, surface area, and hydration changes for equilibrium unfolding and formation of aggregation transition state: High-pressure and cosolute studies on recombinant human IFN-gamma. Proceedings of the National Academy of Sciences. 7259-7264. 2001
- Maintenance of quaternary structure in the frozen state stabilizes lactate dehydrogenase during freeze-drying. Archives of Biochemistry and Biophysics. 35-41. 2001
- In vivo evaluation of antibiotic impregnated beads in a rat osteomyelitis model. Journal of Bioactive and Compatible Polymers. 235-250. 2001
- Use of polymer/sugar mixtures to optimize storage stability of freeze-dried recombinant human interleukin-11.. ACS National Meeting Book of Abstracts. U109-U109. 2001
- In vivo evaluation of gentamicin impregnated polylactic acid beads implanted in sheep. Journal of Bioactive and Compatible Polymers. 119-135. 2001
- Counteracting effects of renal solutes on amyloid fibril formation by immunoglobulin light chains. Journal of Biological Chemistry. 1626-1633. 2001
- The excluding effects of sucrose on a protein chemical degradation pathway: Methionine oxidation in subtilisin. Archives of Biochemistry and Biophysics. 123-132. 2000
- Effect of zinc binding and precipitation on structures of recombinant human growth hormone and nerve growth factor. Journal of Pharmaceutical Sciences. 1480-1485. 2000
- Entrapping intermediates of thermal aggregation in alpha-helical proteins with low concentration of guanidine hydrochloride. Journal of Biological Chemistry. 27689-27693. 2000
- Stability of subtilisin and lysozyme under high hydrostatic pressure. Biotechnology Progress. 630-636. 2000
- Permeability and diffusion in vitreous humor: Implications for drug delivery. Pharmaceutical Research. 664-669. 2000
- Mechanism governing microparticle morphology during precipitation by a compressed antisolvent: Atomization vs nucleation and growth. Journal of Physical Chemistry B. 2725-2735. 2000
- Optimization of storage stability of lyophilized actin using combinations of disaccharides and dextran. Journal of Pharmaceutical Sciences. 199-214. 2000
- Thermodynamic modulation of light chain amyloid fibril formation. Journal of Biological Chemistry. 1570-1574. 2000
- Pressure dependence of subtilisin crystallization kinetics. Journal of Crystal Growth. 678-686. 2000
- High pressure fosters protein refolding from aggregates at high concentrations. Proceedings of the National Academy of Sciences. 13029-13033. 1999
- Water-in-carbon dioxide emulsions: Formation and stability. Langmuir. 6781-6791. 1999
- Pressure effect on subtilisin crystallization and solubility. Journal of Crystal Growth. 563-574. 1999
- Investigation of protein-surfactant interactions by analytical ultracentrifugation and electron paramagnetic resonance: The use of recombinant human tissue factor as an example. Pharmaceutical Research. 808-812. 1999
- Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding. Archives of Biochemistry and Biophysics. 289-298. 1999
- Protein formulation and lyophilization cycle design: Prevention of damage due to freeze-concentration induced phase separation. Biotechnology and Bioengineering. 166-174. 1999
- Role of crystallinity in retention of polymer particle morphology in the presence of compressed carbon dioxide. Macromolecules. 1890-1896. 1999
- Application of a thermodynamic model to the prediction of phase separations in freeze-concentrated formulations for protein lyophilization. Archives of Biochemistry and Biophysics. 191-201. 1999
- Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid. Journal of Pharmaceutical Sciences. 281-290. 1999
- Conformational stability of lyophilized PEGylated proteins in a phase-separating system. Journal of Pharmaceutical Sciences. 58-64. 1999
- Inhibition of stress-induced aggregation of protein therapeutics. Methods in Enzymology. 236-255. 1999
- Effect of Tween 20 on freeze-thawing- and agitation-induced aggregation of recombinant, human factor XIII. Journal of Pharmaceutical Sciences. 1597-1603. 1998
- Effects of additives on the stability of recombinant human factor XIII during freeze-drying and storage in the dried solid. Archives of Biochemistry and Biophysics. 121-134. 1998
- Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions. Journal of Pharmaceutical Sciences. 1554-1559. 1998
- A transient expansion of the native state precedes aggregation of recombinant human interferon-gamma. Proceedings of the National Academy of Sciences. 14142-14146. 1998
- Effects of drying methods and additives on structure and function of actin: Mechanisms of dehydration-induced damage and its inhibition. Archives of Biochemistry and Biophysics. 171-181. 1998
- Aggregation of recombinant human interferon gamma: Kinetics and structural transitions. Journal of Pharmaceutical Sciences. 1069-1076. 1998
- Effects of tween 80 and sucrose on acute short-term stability and long-term storage at -20 degrees C of a recombinant hemoglobin. Journal of Pharmaceutical Sciences. 1062-1068. 1998
- Preparation and in vitro characterization of gentamycin-impregnated biodegradable beads suitable for treatment of osteomyelitis. Journal of Pharmaceutical Sciences. 1149-1154. 1998
- Alveolar macrophage cell line is not activated by exposure to polymeric microspheres. International Journal of Pharmaceutics. 41-49. 1998
- Process variable implications for residual solvent removal and polymer morphology in the formation of gentamycin-loaded poly(L-lactide) microparticles. Pharmaceutical Research. 1233-1237. 1998
- Rotational relaxation in supercritical carbon dioxide.. ACS National Meeting Book of Abstracts. U187-U188. 1998
- Rotational relaxation in supercritical carbon dioxide revisited: A study of solute-induced local density augmentation. Journal of Physical Chemistry A. 1674-1681. 1998
- Effect of salts and sugars on phase separation of polyvinylpyrrolidone-dextran solutions induced by freeze-concentration. Journal of the Chemical Society, Faraday Transactions. 411-417. 1998
- Phase separation of excipients during lyophilization: Effects on protein stability. Journal of Pharmaceutical Sciences. 1198-1203. 1997
- Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: Role in restricted conformational mobility and compaction of native state. Proceedings of the National Academy of Sciences. 11917-11922. 1997
- Manipulation of lyophilization-induced phase separation: Implications for pharmaceutical proteins. Biotechnology Progress. 590-596. 1997
- Water core within perfluoropolyether-based microemulsions formed in supercritical carbon dioxide. Journal of Physical Chemistry B. 6707-6714. 1997
- Rational design of stable lyophilized protein formulations: Some practical advice. Pharmaceutical Research. 969-975. 1997
- Ultrasonic velocity measurements in supercritical jet fuel. Journal of Supercritical Fluids. 65-70. 1997
- Secondary structural protection of freeze-dried lysozyme is lost at high initial trehalose concentrations.. ACS National Meeting Book of Abstracts. 76-IEC. 1997
- Characterization of truncated forms of human tissue factor-surfactant mixed micelles by analytical ultracentrifugation and EPR spectroscopy.. Biophysical Journal. MP311-MP311. 1997
- Controlled release of ionic compounds from poly (L-lactide) microspheres produced by precipitation with a compressed antisolvent. Journal of Controlled Release. 77-85. 1997
- A discussion of limitations on the use of polymers for stabilization of proteins during the freezing portion of lyophilization. ACS Symposium Series. 90-108. 1997
- Surfactant-stabilized protein formulations: A review of protein-surfactants interactions and novel analytical methodologies. ACS Symposium Series. 206-222. 1997
- Effects of phase separating systems on lyophilized hemoglobin. Journal of Pharmaceutical Sciences. 1358-1362. 1996
- Molten globule intermediate of recombinant human growth hormone: Stabilization with surfactants. Biotechnology Progress. 801-809. 1996
- Effects of sugars and polymers on crystallization of poly(ethylene glycol) in frozen solutions: Phase separation between incompatible polymers. Pharmaceutical Research. 1393-1400. 1996
- Toxicology of a PFPE surfactant. Science. 1726-1726. 1996
- Electron paramagnetic resonance spectroscopic measurement of surfactant:protein binding stoichiometries. ACS National Meeting Book of Abstracts. 216-BIOT. 1996
- The effects of polymer liquid-liquid phase separation on hemoglobin during freezing and drying.. ACS National Meeting Book of Abstracts. 140-BIOT. 1996
- Theoretical examination of protein-polymer thermodynamic interactions during freezing.. ACS National Meeting Book of Abstracts. 139-BIOT. 1996
- Do solute-solute interactions affect activation limited reactions? A Brownian dynamics study. Journal of Supercritical Fluids. 51-55. 1996
- Molecular simulation and electron paramagnetic resonance (EPR) studies of rapid bimolecular reactions in supercritical fluids. International Journal of Thermophysics. 471-481. 1996
- Water in carbon dioxide microemulsions: An environment for hydrophiles including proteins. Science. 624-626. 1996
- Influence of local structural correlations on free-radical reactions in supercritical fluids: A hierarchical approach. Industrial && Engineering Chemistry Research. 19-27. 1996
- MOLTEN GLOBULE INTERMEDIATE OF HUMAN GROWTH-HORMONE - CHARACTERIZATION AND INTERACTION WITH SURFACTANTS. Federation proceedings. A1242-A1242. 1995
- THE EFFECTS OF TEMPERATURE AND SURFACTANT CONCENTRATION ON THE CONFORMATIONAL STABILITY OF RECOMBINANT HEMOGLOBIN. ACS National Meeting Book of Abstracts. 197-BIOT. 1995
- EFFECT OF SOLUTE-SOLUTE CORRELATIONS ON RAPID REACTIONS IN SUPERCRITICAL FLUIDS. AIChE Journal. 346-356. 1995
- STABILITY OF PROTEIN FORMULATIONS - INVESTIGATION OF SURFACTANT EFFECTS BY A NOVEL EPR SPECTROSCOPIC TECHNIQUE. Pharmaceutical Research. 2-11. 1995
- DOES CRITICAL CLUSTERING AFFECT REACTION-RATE CONSTANTS - MOLECULAR-DYNAMICS STUDIES IN PURE SUPERCRITICAL FLUIDS. The Journal of physical chemistry. 4173-4179. 1994
- MAPPING OF THE SURFACE OF RECOMBINANT HUMAN GROWTH-HORMONE TO STUDY PROTEIN-SURFACTANT INTERACTIONS. ACS National Meeting Book of Abstracts. 81-BIOT. 1994
- SURFACTANT-PROTEIN INTERACTIONS AND THEIR ROLE IN PROTEIN STABILIZATION. ACS National Meeting Book of Abstracts. 80-BIOT. 1994
- QUASICRITICAL BEHAVIOR OF DENSE-GAS SOLVENT-SOLUTE CLUSTERS AT NEAR-INFINITE DILUTION. AIChE Journal. 1061-1071. 1993
- DENSE-GAS SOLVENT-SOLUTE CLUSTERS AT NEAR-INFINITE DILUTION - EPR SPECTROSCOPIC EVIDENCE. AIChE Journal. 876-884. 1993
- EPR SPECTROSCOPIC INVESTIGATIONS OF PROTEIN-SURFACTANT INTERACTIONS. ACS National Meeting Book of Abstracts. 56-BIOT. 1993
- SUB-MICROMETER-SIZED BIODEGRADABLE PARTICLES OF POLY(L-LACTIC ACID) VIA THE GAS ANTISOLVENT SPRAY PRECIPITATION PROCESS. Biotechnology Progress. 429-435. 1993
- FREE-RADICAL REACTIONS IN SUPERCRITICAL ETHANE - A PROBE OF SUPERCRITICAL FLUID STRUCTURE. The Journal of physical chemistry. 5146-5151. 1992
- MECHANISM OF POLYETHYLENE-GLYCOL INTERACTION WITH THE MOLTEN GLOBULE FOLDING INTERMEDIATE OF BOVINE CARBONIC ANHYDRASE-B. Journal of Biological Chemistry. 3147-3153. 1992
- CALORIMETRIC CONTROL OF FED-BATCH FERMENTATIONS. Biotechnology and Bioengineering. 678-684. 1990
- SUPERCRITICAL FLUID EXTRACTIONS IN BIOTECHNOLOGY. Trends in Biotechnology. 78-82. 1990
- ENZYME-CATALYZED OXIDATION OF CHOLESTEROL IN SUPERCRITICAL CARBON-DIOXIDE. AIChE Journal. 1354-1360. 1988
- CHOLESTEROL AGGREGATION AND INTERACTION WITH CHOLESTEROL OXIDASE IN SUPERCRITICAL CARBON-DIOXIDE. Proceedings of the National Academy of Sciences. 2979-2983. 1988
- ENZYMATIC OXIDATION OF CHOLESTEROL AGGREGATES IN SUPERCRITICAL CARBON-DIOXIDE. Science. 387-390. 1988
- EFFECT OF ENZYME AND SUBSTRATE CONFORMATION ON ENZYMATIC-ACTIVITY IN A SUPERCRITICIAL FLUID - KINETIC AND ELECTRON-SPIN-RESONANCE STUDIES. ACS National Meeting Book of Abstracts. 24-MBTD. 1987
- ENZYMATIC CATALYSIS IN A SUPERCRITICAL FLUID. Biotechnology Techniques. 325-328. 1985

Background

education and training

Ph.D., University of California-Berkeley 1987
B.S., University of Colorado Boulder 1983

awards and honors

AAPS Dale E. Wurster Research Award (American Association Of Pharmaceutical Scientists), conferred by American Association Of Pharmaceutical Scientists, 2010
Distinguished Engineering Alumni Award (College of Engineering and Applied Science), conferred by College of Engineering and Applied Science, 2009
Distinguished Interdepartmental Inventors (Office of Technology Transfer), conferred by Office of Technology Transfer, 2008
Ebert Prize (American Pharmacists Association), conferred by American Pharmacists Association, 2007
Chemical Engineering Division/Chemstations Lectureship Award (American Society for Engineering Education), conferred by American Society for Engineering Education, 2007
Andreas Acrivos Award for Professional Progress in Chemical Engineering (American Institute of Chemical Engineers), conferred by American Institute of Chemical Engineers, 2005
BFA Award for Excellence in Research, Scholarly and Creative Work (Boulder Faculty Assembly), conferred by Boulder Faculty Assembly, 2003
Engr Faculty Research Award (College of Engineering and Applied Science), conferred by College of Engineering and Applied Science, 2000

International Activities

global connections related to teaching and scholarly work (in recent years)

Europe Continent
France Country
Japan Country
Netherlands Country

Other Profiles

ORCID iD

http://orcid.org/0000-0002-4292-4047