Published in Nat Biotechnol on June 01, 2006
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Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm Res (2011) 1.31
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Measurement of anti-erythropoiesis-stimulating agent IgG4 antibody as an indicator of antibody-mediated pure red cell aplasia. Clin Vaccine Immunol (2012) 0.79
Reactions to Eprex's adverse reactions. Nat Biotechnol (2006) 0.78
Antibody-mediated pure red cell aplasia (PRCA) on switching from darbepoetin alfa to epoetin beta: what are the implications? NDT Plus (2008) 0.75
Critical evaluation of Nanoparticle Tracking Analysis (NTA) by NanoSight for the measurement of nanoparticles and protein aggregates. Pharm Res (2010) 3.40
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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
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
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
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
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
Antibody response to aggregated human interferon alpha2b in wild-type and transgenic immune tolerant mice depends on type and level of aggregation. J Pharm Sci (2006) 1.32
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
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
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
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
The safety of switching between therapeutic proteins. Expert Opin Biol Ther (2012) 1.12
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
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
Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm (2003) 1.02
Rational design of nasal vaccines. J Drug Target (2008) 1.02
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
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
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
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
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
Towards heat-stable oxytocin formulations: analysis of degradation kinetics and identification of degradation products. Pharm Res (2009) 0.94
Antibodies against erythropoietin and other protein-based therapeutics: an overview. Ann N Y Acad Sci (2005) 0.94
Dendritic cells process synthetic long peptides better than whole protein, improving antigen presentation and T-cell activation. Eur J Immunol (2013) 0.93
PLGA, PLGA-TMC and TMC-TPP nanoparticles differentially modulate the outcome of nasal vaccination by inducing tolerance or enhancing humoral immunity. PLoS One (2011) 0.93
Hybrid transgenic immune tolerant mouse model for assessing the breaking of B cell tolerance by human interferon beta. J Immunol Methods (2009) 0.93
Small amounts of sub-visible aggregates enhance the immunogenic potential of monoclonal antibody therapeutics. Pharm Res (2015) 0.92
Development of a transgenic mouse model immune tolerant for human interferon Beta. Pharm Res (2005) 0.92
Particles in therapeutic protein formulations, Part 1: overview of analytical methods. J Pharm Sci (2011) 0.92
Detection and characterization of subvisible aggregates of monoclonal IgG in serum. Pharm Res (2012) 0.92
Oxidation of therapeutic proteins and peptides: structural and biological consequences. Pharm Res (2013) 0.92
On the role of aggregates in the immunogenicity of recombinant human interferon beta in patients with multiple sclerosis. J Interferon Cytokine Res (2010) 0.91
Physicochemical studies on the stability of influenza haemagglutinin in vaccine bulk material. Eur J Pharm Sci (2004) 0.91
Hemoglobin variability in patients with chronic kidney disease in the Netherlands. Int J Artif Organs (2009) 0.91
Near-infrared imaging for studying homogeneity of protein-sugar mixtures. Pharm Res (2006) 0.91
OVCAR-3 cells internalize TAT-peptide modified liposomes by endocytosis. Biochim Biophys Acta (2004) 0.90
Physicochemical and immunochemical techniques predict the quality of diphtheria toxoid vaccines. Vaccine (2003) 0.90
Recombinant gelatin hydrogels for the sustained release of proteins. J Control Release (2007) 0.90
Fluorescent molecular rotors as dyes to characterize polysorbate-containing IgG formulations. Pharm Res (2009) 0.90
Macrophages inhibit human osteosarcoma cell growth after activation with the bacterial cell wall derivative liposomal muramyl tripeptide in combination with interferon-γ. J Exp Clin Cancer Res (2014) 0.89
Restored functional immunogenicity of purified meningococcal PorA by incorporation into liposomes. Vaccine (2003) 0.89
Neutralising antibodies to interferon beta in multiple sclerosis : expert panel report. J Neurol (2007) 0.89
Co-encapsulation of antigen and Toll-like receptor ligand in cationic liposomes affects the quality of the immune response in mice after intradermal vaccination. Vaccine (2010) 0.89
Adjuvanted, antigen loaded N-trimethyl chitosan nanoparticles for nasal and intradermal vaccination: adjuvant- and site-dependent immunogenicity in mice. Eur J Pharm Sci (2011) 0.89
The Rebif new formulation story: it's not trials and error. Drugs R D (2007) 0.89
Fluorescence single particle tracking for the characterization of submicron protein aggregates in biological fluids and complex formulations. Pharm Res (2011) 0.88
Efficient induction of immune responses through intradermal vaccination with N-trimethyl chitosan containing antigen formulations. J Control Release (2009) 0.88
Models for evaluation of relative immunogenic potential of protein particles in biopharmaceutical protein formulations. J Pharm Sci (2012) 0.88
Immunogenicity of rDNA-derived pharmaceuticals. Trends Pharmacol Sci (2002) 0.88
Conformational analysis of opacity proteins from Neisseria meningitidis. Eur J Biochem (2002) 0.88
Distinct effects of sucrose and trehalose on protein stability during supercritical fluid drying and freeze-drying. Eur J Pharm Sci (2005) 0.87