Published in J Pharm Sci on May 01, 2006
Quality of original and biosimilar epoetin products. Pharm Res (2010) 1.46
Immunogenicity of protein therapeutics: The key causes, consequences and challenges. Self Nonself (2010) 1.45
Challenges and approaches for the development of safer immunomodulatory biologics. Nat Rev Drug Discov (2013) 1.35
Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol (2013) 1.32
Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm Res (2011) 1.31
Classification and characterization of therapeutic antibody aggregates. J Biol Chem (2011) 1.28
Immunogenicity of therapeutic proteins: the use of animal models. Pharm Res (2011) 1.22
Immunogenicity of therapeutic proteins: influence of aggregation. J Immunotoxicol (2013) 1.10
Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses. J Biol Chem (2012) 1.09
Chemical modifications in therapeutic protein aggregates generated under different stress conditions. J Biol Chem (2011) 1.05
Aggregated recombinant human interferon Beta induces antibodies but no memory in immune-tolerant transgenic mice. Pharm Res (2010) 1.05
Emerging trends in plasma-free manufacturing of recombinant protein therapeutics expressed in mammalian cells. Biotechnol J (2009) 1.05
Immunogenicity of different stressed IgG monoclonal antibody formulations in immune tolerant transgenic mice. MAbs (2012) 0.98
Follicular dendritic cells in health and disease. Front Immunol (2012) 0.90
Protein particulate detection issues in biotherapeutics development--current status. AAPS PharmSciTech (2012) 0.88
Accelerated dosing frequency of a pulmonary formulation of tissue plasminogen activator is well-tolerated in mice. Clin Exp Pharmacol Physiol (2008) 0.87
Native-like aggregates of factor VIII are immunogenic in von Willebrand factor deficient and hemophilia a mice. J Pharm Sci (2012) 0.84
Post-production protein stability: trouble beyond the cell factory. Microb Cell Fact (2011) 0.84
Chemical modifications in aggregates of recombinant human insulin induced by metal-catalyzed oxidation: covalent cross-linking via michael addition to tyrosine oxidation products. Pharm Res (2012) 0.82
Effects of disulfide bond formation and protein helicity on the aggregation of activating transcription factor 5. Mol Pharm (2009) 0.81
A multi-tiered analytical approach for the analysis and quantitation of high-molecular-weight aggregates in a recombinant therapeutic glycoprotein. AAPS J (2009) 0.81
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
Identification of oxidation sites and covalent cross-links in metal catalyzed oxidized interferon Beta-1a: potential implications for protein aggregation and immunogenicity. Mol Pharm (2013) 0.80
Influence of the valine zipper region on the structure and aggregation of the basic leucine zipper (bZIP) domain of activating transcription factor 5 (ATF5). Mol Pharm (2012) 0.77
Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges. J Pharm Sci (2016) 0.76
Influence of aggregation and route of injection on the biodistribution of mouse serum albumin. PLoS One (2014) 0.76
Explaining the non-newtonian character of aggregating monoclonal antibody solutions using small-angle neutron scattering. Biophys J (2014) 0.76
Role of benzyl alcohol in the unfolding and aggregation of interferon α-2a. J Pharm Sci (2014) 0.76
Microparticles and Nanoparticles Delivered in Intravenous Saline and in an Intravenous Solution of a Therapeutic Antibody Product. J Pharm Sci (2016) 0.75
The Role of Aggregates of Therapeutic Protein Products in Immunogenicity: An Evaluation by Mathematical Modeling. J Immunol Res (2015) 0.75
Evaluation of Microflow Digital Imaging Particle Analysis for Sub-Visible Particles Formulated with an Opaque Vaccine Adjuvant. PLoS One (2016) 0.75
Antimicrobial preservatives induce aggregation of interferon alpha-2a: the order in which preservatives induce protein aggregation is independent of the protein. Int J Pharm (2014) 0.75
Charge-mediated Fab-Fc interactions in an IgG1 antibody induce reversible self-association, cluster formation, and elevated viscosity. MAbs (2016) 0.75
Why the Immune System Should Be Concerned by Nanomaterials? Front Immunol (2017) 0.75
Critical evaluation of Nanoparticle Tracking Analysis (NTA) by NanoSight for the measurement of nanoparticles and protein aggregates. Pharm Res (2010) 3.40
Extrinsic fluorescent dyes as tools for protein characterization. Pharm Res (2008) 2.63
Identification of formaldehyde-induced modifications in proteins: reactions with model peptides. J Biol Chem (2003) 2.60
Structure-immunogenicity relationships of therapeutic proteins. Pharm Res (2004) 2.39
Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights. Kidney Int (2012) 2.38
Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci (2009) 2.36
Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA (2008) 2.33
ESAT-6 from Mycobacterium tuberculosis dissociates from its putative chaperone CFP-10 under acidic conditions and exhibits membrane-lysing activity. J Bacteriol (2007) 2.31
Reassessments of ESAs for cancer treatment in the US and Europe. Oncology (Williston Park) (2010) 2.22
Plasmin cleavage of von Willebrand factor as an emergency bypass for ADAMTS13 deficiency in thrombotic microangiopathy. Circulation (2014) 2.16
Eprex-associated pure red cell aplasia and leachates. Nat Biotechnol (2006) 1.98
Mechanistic study of the adjuvant effect of biodegradable nanoparticles in mucosal vaccination. J Control Release (2009) 1.81
Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant (2006) 1.74
Misfolded proteins activate factor XII in humans, leading to kallikrein formation without initiating coagulation. J Clin Invest (2008) 1.59
Artificial viruses: a nanotechnological approach to gene delivery. Nat Rev Drug Discov (2006) 1.52
Microneedle technologies for (trans)dermal drug and vaccine delivery. J Control Release (2012) 1.49
Quality of original and biosimilar epoetin products. Pharm Res (2010) 1.46
Mast cells increase vascular permeability by heparin-initiated bradykinin formation in vivo. Immunity (2011) 1.46
Recommendations for clinical use of data on neutralising antibodies to interferon-beta therapy in multiple sclerosis. Lancet Neurol (2010) 1.37
Identification of formaldehyde-induced modifications in proteins: reactions with insulin. Bioconjug Chem (2006) 1.37
In vivo roles of factor XII. Blood (2012) 1.37
Stimulation of angiogenesis by Ras proteins. Biochim Biophys Acta (2004) 1.35
Strategies for the assessment of protein aggregates in pharmaceutical biotech product development. Pharm Res (2010) 1.35
Micelle-associated protein in epoetin formulations: aA risk factor for immunogenicity? Pharm Res (2003) 1.34
Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b. Pharm Res (2005) 1.32
Biosimilar epoetins: an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins. Pharmacotherapy (2005) 1.31
Interchangeability, immunogenicity and biosimilars. Nat Biotechnol (2012) 1.28
Chitosan-based delivery systems for protein therapeutics and antigens. Adv Drug Deliv Rev (2009) 1.26
Adjuvant effect of cationic liposomes and CpG depends on administration route. J Control Release (2011) 1.24
Structural properties of monoclonal antibody aggregates induced by freeze-thawing and thermal stress. Eur J Pharm Sci (2009) 1.23
Immunological mechanism underlying the immune response to recombinant human protein therapeutics. Trends Pharmacol Sci (2009) 1.23
Immunogenicity of therapeutic proteins: the use of animal models. Pharm Res (2011) 1.22
Liver regeneration is an angiogenesis- associated phenomenon. Ann Surg (2002) 1.21
The therapeutic equivalence of complex drugs. Regul Toxicol Pharmacol (2010) 1.20
Administration routes affect the quality of immune responses: A cross-sectional evaluation of particulate antigen-delivery systems. J Control Release (2010) 1.20
A role for protein misfolding in immunogenicity of biopharmaceuticals. J Biol Chem (2006) 1.19
How to screen non-viral gene delivery systems in vitro? J Control Release (2011) 1.17
Forced degradation of therapeutic proteins. J Pharm Sci (2011) 1.16
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
Molecular and cellular aspects of protein misfolding and disease. FASEB J (2008) 1.14
Advances in transcutaneous vaccine delivery: do all ways lead to Rome? J Control Release (2010) 1.13
Preparation and characterization of protein-loaded N-trimethyl chitosan nanoparticles as nasal delivery system. J Control Release (2005) 1.13
Glycation induces formation of amyloid cross-beta structure in albumin. J Biol Chem (2003) 1.12
The safety of switching between therapeutic proteins. Expert Opin Biol Ther (2012) 1.12
PDGFRB promotes liver metastasis formation of mesenchymal-like colorectal tumor cells. Neoplasia (2013) 1.11
Pure red cell aplasia induced by erythropoiesis-stimulating agents. Clin J Am Soc Nephrol (2008) 1.11
Immune response to immunotherapy: the role of neutralising antibodies to interferon beta in the treatment of multiple sclerosis. Lancet Neurol (2005) 1.10
Endosomal escape of polymeric gene delivery complexes is not always enhanced by polymers buffering at low pH. Biomacromolecules (2004) 1.09
The nuclear pore complex: the gateway to successful nonviral gene delivery. Pharm Res (2006) 1.07
Aggregated recombinant human interferon Beta induces antibodies but no memory in immune-tolerant transgenic mice. Pharm Res (2010) 1.05
Towards tailored vaccine delivery: needs, challenges and perspectives. J Control Release (2012) 1.03
Interaction of dendritic cells with antigen-containing liposomes: effect of bilayer composition. Vaccine (2004) 1.03
Functional characterization of an endosome-disruptive peptide and its application in cytosolic delivery of immunoliposome-entrapped proteins. J Biol Chem (2002) 1.02
Self-assembly of recombinant amphiphilic oligopeptides into vesicles. Biomacromolecules (2007) 1.02
Sensitive spectroscopic detection of large and denatured protein aggregates in solution by use of the fluorescent dye Nile red. J Fluoresc (2007) 1.02
Immunological risk of injectable drug delivery systems. Pharm Res (2009) 1.02
Rational design of nasal vaccines. J Drug Target (2008) 1.02
Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm (2003) 1.02
Tissue-type plasminogen activator is a multiligand cross-beta structure receptor. Curr Biol (2002) 1.01
Erythropoietin-Associated PRCA: Still an Unsolved Mystery. J Immunotoxicol (2006) 0.99
Immunogenicity of different stressed IgG monoclonal antibody formulations in immune tolerant transgenic mice. MAbs (2012) 0.98
Flow imaging microscopy for protein particle analysis--a comparative evaluation of four different analytical instruments. AAPS J (2013) 0.98
Polymer side-chain degradation as a tool to control the destabilization of polyplexes. Pharm Res (2004) 0.98
Online fluorescent dye detection method for the characterization of immunoglobulin G aggregation by size exclusion chromatography and asymmetrical flow field flow fractionation. Anal Biochem (2008) 0.97
Receptor protein tyrosine phosphatase mu expression as a marker for endothelial cell heterogeneity; analysis of RPTPmu gene expression using LacZ knock-in mice. Int J Dev Biol (2003) 0.97
Conjugation of ovalbumin to trimethyl chitosan improves immunogenicity of the antigen. J Control Release (2010) 0.97
Mass spectrometric analysis of intact human monoclonal antibody aggregates fractionated by size-exclusion chromatography. Pharm Res (2010) 0.97
Poly(3-guanidinopropyl methacrylate): a novel cationic polymer for gene delivery. Bioconjug Chem (2004) 0.97
Oxidized and aggregated recombinant human interferon beta is immunogenic in human interferon beta transgenic mice. Pharm Res (2011) 0.97
Probing metal ion binding and conformational properties of the colicin E9 endonuclease by electrospray ionization time-of-flight mass spectrometry. Protein Sci (2002) 0.96
A monoclonal antibody against synthetic Aβ dimer assemblies neutralizes brain-derived synaptic plasticity-disrupting Aβ. J Neurochem (2011) 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
Taylor dispersion analysis compared to dynamic light scattering for the size analysis of therapeutic peptides and proteins and their aggregates. Pharm Res (2011) 0.95
N-trimethyl chitosan (TMC) nanoparticles loaded with influenza subunit antigen for intranasal vaccination: biological properties and immunogenicity in a mouse model. Vaccine (2006) 0.94
Fibronectin is a hypoxia-independent target of the tumor suppressor VHL. FEBS Lett (2004) 0.94
A novel family of L-amino acid-based biodegradable polymer-lipid conjugates for the development of long-circulating liposomes with effective drug-targeting capacity. Bioconjug Chem (2003) 0.94
Controlled release of octreotide and assessment of peptide acylation from poly(D,L-lactide-co-hydroxymethyl glycolide) compared to PLGA microspheres. Pharm Res (2011) 0.94
Recombinant endostatin forms amyloid fibrils that bind and are cytotoxic to murine neuroblastoma cells in vitro. FEBS Lett (2003) 0.94