Published in J Pharm Sci on January 22, 2014
Advances in recombinant antibody manufacturing. Appl Microbiol Biotechnol (2016) 0.85
Physicochemical and biological characterization of a biosimilar trastuzumab. Biomed Res Int (2015) 0.82
Physical characterization and in vitro biological impact of highly aggregated antibodies separated into size-enriched populations by fluorescence-activated cell sorting. J Pharm Sci (2015) 0.80
Characterization of the physical stability of a lyophilized IgG1 mAb after accelerated shipping-like stress. J Pharm Sci (2014) 0.79
Posttranslational Modifications and the Immunogenicity of Biotherapeutics. J Immunol Res (2016) 0.76
Design and Evaluation of the Highly Concentrated Human IgG Formulation Using Cyclodextrin Polypseudorotaxane Hydrogels. AAPS PharmSciTech (2015) 0.75
AlphaScreen-based homogeneous assay using a pair of 25-residue artificial proteins for high-throughput analysis of non-native IgG. Sci Rep (2017) 0.75
Effect of Aggregation on the Hydrodynamic Properties of Bovine Serum Albumin. Pharm Res (2017) 0.75
Effects of protein aggregates: an immunologic perspective. AAPS J (2006) 4.74
Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation. Pharm Res (2003) 4.01
Extrinsic fluorescent dyes as tools for protein characterization. Pharm Res (2008) 2.63
Challenges in the development of high protein concentration formulations. J Pharm Sci (2004) 2.52
Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov (2002) 2.49
Protein aggregation and bioprocessing. AAPS J (2006) 2.47
Structure-immunogenicity relationships of therapeutic proteins. Pharm Res (2004) 2.39
Protein aggregation and its inhibition in biopharmaceutics. Int J Pharm (2005) 2.26
Protein aggregation: pathways, induction factors and analysis. J Pharm Sci (2009) 2.04
Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony-stimulating factor. Protein Sci (2003) 1.51
Protein aggregation--pathways and influencing factors. Int J Pharm (2010) 1.44
Classification and characterization of therapeutic antibody aggregates. J Biol Chem (2011) 1.28
Shaken, not stirred: mechanical stress testing of an IgG1 antibody. J Pharm Sci (2008) 1.28
Structural properties of monoclonal antibody aggregates induced by freeze-thawing and thermal stress. Eur J Pharm Sci (2009) 1.23
Induction and analysis of aggregates in a liquid IgG1-antibody formulation. Eur J Pharm Biopharm (2005) 1.20
Forced degradation of therapeutic proteins. J Pharm Sci (2011) 1.16
Characterization of particles in protein solutions: reaching the limits of current technologies. AAPS J (2010) 1.16
Effects of solution conditions, processing parameters, and container materials on aggregation of a monoclonal antibody during freeze-thawing. J Pharm Sci (2008) 1.16
Temperature-induced changes in protein structures studied by Fourier transform infrared spectroscopy and global analysis. Biochemistry (1995) 1.15
Immunogenicity of protein aggregates--concerns and realities. Int J Pharm (2012) 1.14
Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses. J Biol Chem (2012) 1.09
Quantification and characterization of subvisible proteinaceous particles in opalescent mAb formulations using micro-flow imaging. J Pharm Sci (2010) 1.09
Chemical modifications in therapeutic protein aggregates generated under different stress conditions. J Biol Chem (2011) 1.05
Distinct aggregation mechanisms of monoclonal antibody under thermal and freeze-thaw stresses revealed by hydrogen exchange. Pharm Res (2011) 1.00
Immunogenicity of different stressed IgG monoclonal antibody formulations in immune tolerant transgenic mice. MAbs (2012) 0.98
Structural changes of IgG induced by heat treatment and by adsorption onto a hydrophobic Teflon surface studied by circular dichroism spectroscopy. Biochim Biophys Acta (1998) 0.98
Protein particles: what we know and what we do not know. J Pharm Sci (2012) 0.98
Classification of protein aggregates. J Pharm Sci (2011) 0.97
Improved data visualization techniques for analyzing macromolecule structural changes. Protein Sci (2012) 0.96
Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation. J Pharm Sci (2010) 0.95
Micro-flow imaging and resonant mass measurement (Archimedes)--complementary methods to quantitatively differentiate protein particles and silicone oil droplets. J Pharm Sci (2013) 0.95
Protein stability in ice. Biophys J (2006) 0.94
Characterization of antibody aggregation: role of buried, unpaired cysteines in particle formation. J Pharm Sci (2010) 0.93
Managing uncertainty: a perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins. J Pharm Sci (2012) 0.93
Particles in therapeutic protein formulations, Part 1: overview of analytical methods. J Pharm Sci (2011) 0.92
Implementation of an FTIR calibration curve for fast and objective determination of changes in protein secondary structure during formulation development. J Pharm Biomed Anal (2009) 0.92
Effect of additives on protein aggregation. Curr Pharm Biotechnol (2009) 0.91
Inhibition of agitation-induced aggregation of an IgG-antibody by hydroxypropyl-beta-cyclodextrin. J Pharm Sci (2010) 0.90
Compatibility, physical stability, and characterization of an IgG4 monoclonal antibody after dilution into different intravenous administration bags. J Pharm Sci (2012) 0.90
Detection of IgG aggregation by a high throughput method based on extrinsic fluorescence. J Pharm Sci (2010) 0.89
Evaluation of a dual-wavelength size exclusion HPLC method with improved sensitivity to detect protein aggregates and its use to better characterize degradation pathways of an IgG1 monoclonal antibody. J Pharm Sci (2010) 0.89
Aggregation mechanism of an IgG2 and two IgG1 monoclonal antibodies at low pH: from oligomers to larger aggregates. Pharm Res (2012) 0.89
Electron microscopic morphology of immunoglobulin aggregates and their interactions in rheumatoid articular collagenous tissues. Arthritis Rheum (1978) 0.88
Immunogenicity of therapeutic proteins. Nephrol Dial Transplant (2003) 0.88
Process analytics for purification of monoclonal antibodies. J Chromatogr B Analyt Technol Biomed Life Sci (2006) 0.88
Effects of additives on the stability of recombinant human factor XIII during freeze-drying and storage in the dried solid. Arch Biochem Biophys (1998) 0.87
The future of protein particle characterization and understanding its potential to diminish the immunogenicity of biopharmaceuticals: a shared perspective. J Pharm Sci (2012) 0.85
Relevant shaking stress conditions for antibody preformulation development. Eur J Pharm Biopharm (2009) 0.83
Conformational analysis of protein secondary structure during spray-drying of antibody/mannitol formulations. Eur J Pharm Biopharm (2006) 0.83
Effect of glycine on pH changes and protein stability during freeze-thawing in phosphate buffer systems. J Pharm Sci (2002) 0.83
Structure, stability, and mobility of a lyophilized IgG1 monoclonal antibody as determined using second-derivative infrared spectroscopy. J Pharm Sci (2011) 0.82
Radar chart array analysis to visualize effects of formulation variables on IgG1 particle formation as measured by multiple analytical techniques. J Pharm Sci (2013) 0.82
Asymmetrical flow field-flow fractionation method for the analysis of submicron protein aggregates. J Pharm Sci (2012) 0.81
Flow imaging: moving toward best practices for subvisible particle quantitation in protein products. J Pharm Sci (2013) 0.81
Congo red-stabilized intermediates in the lambda light chain transition from native to molten state. Biochimie (1996) 0.81
Proteins behaving badly: emerging technologies in profiling biopharmaceutical aggregation. Trends Biotechnol (2013) 0.79
Protection mechanism of Tween 80 during freeze-thawing of a model protein, LDH. Int J Pharm (2002) 0.78
Workshop on predictive science of the immunogenicity aspects of particles in biopharmaceutical products. J Pharm Sci (2012) 0.76
A critical evaluation of Tm(FTIR) measurements of high-concentration IgG1 antibody formulations as a formulation development tool. Pharm Res (2006) 0.76
Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature (2002) 12.49
Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci (2009) 2.36
IpaD localizes to the tip of the type III secretion system needle of Shigella flexneri. Infect Immun (2006) 2.24
Nanotechnology in vaccine delivery. Adv Drug Deliv Rev (2008) 1.91
Barriers to nonviral gene delivery. J Pharm Sci (2003) 1.77
Biophysical characterization of PEI/DNA complexes. J Pharm Sci (2003) 1.44
Vaccine-induced immunity in baboons by using DNA and replication-incompetent adenovirus type 5 vectors expressing a human immunodeficiency virus type 1 gag gene. J Virol (2003) 1.41
Conformational stability and disassembly of Norwalk virus-like particles. Effect of pH and temperature. J Biol Chem (2006) 1.41
Silicone oil induced aggregation of proteins. J Pharm Sci (2005) 1.32
Preparation and characterization of translocator/chaperone complexes and their component proteins from Shigella flexneri. Biochemistry (2007) 1.32
Structure/function relationships of polyamidoamine/DNA dendrimers as gene delivery vehicles. J Pharm Sci (2005) 1.27
Development of stable liquid formulations for adenovirus-based vaccines. J Pharm Sci (2004) 1.26
Polyanions and the proteome. Mol Cell Proteomics (2004) 1.24
Derivative absorbance spectroscopy and protein phase diagrams as tools for comprehensive protein characterization: a bGCSF case study. J Pharm Sci (2003) 1.21
Effects of adsorption to aluminum salt adjuvants on the structure and stability of model protein antigens. J Biol Chem (2005) 1.19
Protein-excipient interactions: mechanisms and biophysical characterization applied to protein formulation development. Adv Drug Deliv Rev (2011) 1.19
Thermal stability of vaccines. J Pharm Sci (2003) 1.17
Structural stability of adenovirus type 5. J Pharm Sci (2003) 1.17
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. J Pharm Sci (2010) 1.16
Structure-function analysis of invasion plasmid antigen C (IpaC) from Shigella flexneri. J Biol Chem (2002) 1.15
Disassembly and reassembly of yeast-derived recombinant human papillomavirus virus-like particles (HPV VLPs). J Pharm Sci (2006) 1.15
Physical characterization of MxiH and PrgI, the needle component of the type III secretion apparatus from Shigella and Salmonella. Protein Sci (2006) 1.11
Conformational stability and differential structural analysis of LcrV, PcrV, BipD, and SipD from type III secretion systems. Protein Sci (2007) 1.10
Properties of synthetic spider silk fibers based on Argiope aurantia MaSp2. Biomacromolecules (2008) 1.08
A rapid, three-step process for the preformulation of a recombinant ricin toxin A-chain vaccine. J Pharm Sci (2007) 1.06
Anthrax vaccine powder formulations for nasal mucosal delivery. J Pharm Sci (2006) 1.04
Comparability assessments of process and product changes made during development of two different monoclonal antibodies. Biologicals (2010) 1.04
Effect of metal cations on the conformation and inactivation of recombinant human factor VIII. J Pharm Sci (2004) 1.04
Influence of aggregation on immunogenicity of recombinant human Factor VIII in hemophilia A mice. J Pharm Sci (2006) 1.04
The complex inter-relationships between protein flexibility and stability. J Pharm Sci (2008) 1.02
The structure of DNA within cationic lipid/DNA complexes. Biophys J (2003) 1.01
Analytical lessons learned from selected therapeutic protein drug comparability studies. Biologicals (2012) 1.00
Spectroscopic and calorimetric analyses of invasion plasmid antigen D (IpaD) from Shigella flexneri reveal the presence of two structural domains. Biochemistry (2006) 1.00
Stabilization of human papillomavirus virus-like particles by non-ionic surfactants. J Pharm Sci (2005) 1.00
Identification of properties important to protein aggregation using feature selection. BMC Bioinformatics (2013) 1.00
Effects of stabilizers on the destabilization of proteins upon adsorption to aluminum salt adjuvants. J Pharm Sci (2007) 1.00
Oligomeric states of the Shigella translocator protein IpaB provide structural insights into formation of the type III secretion translocon. Protein Sci (2013) 0.99
Effects of solutes on empirical phase diagrams of human fibroblast growth factor 1. J Pharm Sci (2007) 0.99
Insulin containing polyethylenimine-dextran sulfate nanoparticles. Int J Pharm (2003) 0.99
Characterization of the interaction of single tryptophan containing mutants of IpaC from Shigella flexneri with phospholipid membranes. Biochemistry (2006) 0.98
Multidimensional methods for the formulation of biopharmaceuticals and vaccines. J Pharm Sci (2011) 0.98
A novel scoring function for discriminating hyperthermophilic and mesophilic proteins with application to predicting relative thermostability of protein mutants. BMC Bioinformatics (2010) 0.98
Lipid binding region (2303-2332) is involved in aggregation of recombinant human FVIII (rFVIII). J Pharm Sci (2005) 0.96
Improved data visualization techniques for analyzing macromolecule structural changes. Protein Sci (2012) 0.96
Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation. J Pharm Sci (2010) 0.95
Stability of the Clostridium botulinum type A neurotoxin complex: an empirical phase diagram based approach. Mol Pharm (2007) 0.95
Translocation of Borrelia burgdorferi surface lipoprotein OspA through the outer membrane requires an unfolded conformation and can initiate at the C-terminus. Mol Microbiol (2010) 0.94
High-throughput biophysical analysis of protein therapeutics to examine interrelationships between aggregate formation and conformational stability. AAPS J (2013) 0.94
Protein instability and immunogenicity: roadblocks to clinical application of injectable protein delivery systems for sustained release. J Pharm Sci (2011) 0.94
A systematic approach to stabilizing EBA-175 RII-NG for use as a malaria vaccine. Vaccine (2006) 0.93
Structural stability of vault particles. J Pharm Sci (2009) 0.93
Biophysical characterization of Chlamydia trachomatis CT584 supports its potential role as a type III secretion needle tip protein. Biochemistry (2009) 0.92
Effects of pH and polyanions on the thermal stability of fibroblast growth factor 20. Mol Pharm (2007) 0.92
An empirical phase diagram approach to investigate conformational stability of "second-generation" functional mutants of acidic fibroblast growth factor-1. Protein Sci (2012) 0.92
Using empirical phase diagrams to understand the role of intramolecular dynamics in immunoglobulin G stability. J Pharm Sci (2009) 0.92
Parenteral immunization with IpaB/IpaD protects mice against lethal pulmonary infection by Shigella. Vaccine (2013) 0.91
Comparative kinetics of cofactor association and dissociation for the human and trypanosomal S-adenosylhomocysteine hydrolases. 1. Basic features of the association and dissociation processes. Biochemistry (2007) 0.91
Compatibility, physical stability, and characterization of an IgG4 monoclonal antibody after dilution into different intravenous administration bags. J Pharm Sci (2012) 0.90
Advances in vaccines against neglected tropical diseases: enhancing physical stability of a recombinant hookworm vaccine through biophysical and formulation studies. Hum Vaccin Immunother (2012) 0.90
Compositional effects of cationic lipid/DNA delivery systems on transgene expression in cell culture. J Pharm Sci (2004) 0.89
Evaluation of a dual-wavelength size exclusion HPLC method with improved sensitivity to detect protein aggregates and its use to better characterize degradation pathways of an IgG1 monoclonal antibody. J Pharm Sci (2010) 0.89
Solution behavior of IFN-beta-1a: an empirical phase diagram based approach. J Pharm Sci (2005) 0.89
A biophysical characterization of the peptide drug pramlintide (AC137) using empirical phase diagrams. J Pharm Sci (2008) 0.89
The structural organization of cationic lipid-DNA complexes. J Biol Chem (2002) 0.89
Aggregation kinetics of recombinant human FVIII (rFVIII). J Pharm Sci (2005) 0.89
A network-based analysis of polyanion-binding proteins utilizing human protein arrays. J Biol Chem (2007) 0.89
Investigation of protein conformational stability employing a multimodal spectrometer. Anal Chem (2011) 0.89
Effect of single-point mutations on the stability and immunogenicity of a recombinant ricin A chain subunit vaccine antigen. Hum Vaccin Immunother (2013) 0.88
N-terminus of IpaB provides a potential anchor to the Shigella type III secretion system tip complex protein IpaD. Biochemistry (2013) 0.88
Evaluation of the physical stability of the EC5 domain of E-cadherin: effects of pH, temperature, ionic strength, and disulfide bonds. J Pharm Sci (2009) 0.88
An improved methodology for multidimensional high-throughput preformulation characterization of protein conformational stability. J Pharm Sci (2012) 0.88
Electrostatic changes in phosphorylase kinase induced by its obligatory allosteric activator Ca2+. Protein Sci (2007) 0.88