ArticlePharmaceutical research2015
Investigation of the immunogenicity of different types of aggregates of a murine monoclonal antibody in mice.
Article in Pharmaceutical research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
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Who cites it
21 citing papers in PubMed.
- Highly variable aggregation and glycosylation profiles and their roles in immunogenicity to protein-based therapeutics.Journal of pharmaceutical sciences · 2025Review
- Machine Learning Analysis Provides Insight into Mechanisms of Protein Particle Formation Inside Containers During Mechanical Agitation.Journal of pharmaceutical sciences · 2022Article
- Aggregates Associated with Instability of Antibodies during Aerosolization Induce Adverse Immunological Effects.Pharmaceutics · 2022Article
- Unexplored Excipients in Biotherapeutic Formulations: Natural Osmolytes as Potential Stabilizers Against Thermally Induced Aggregation of IgG1 Biotherapeutics.AAPS PharmSciTech · 2021Article
- Full-length G glycoprotein directly extracted from rabies virus with detergent and then stabilized by amphipols in liquid and freeze-dried forms.Biotechnology and bioengineering · 2021Article
- Solubility Controlling Peptide Tags of Opposite Charges Generate a Bivalent Immune Response Against Dengue ED3 Serotypes 3 and 4.Frontiers in immunology · 2021Article
- Particle Detection and Characterization for Biopharmaceutical Applications: Current Principles of Established and Alternative Techniques.Pharmaceutics · 2020Review
- Machine learning and statistical analyses for extracting and characterizing "fingerprints" of antibody aggregation at container interfaces from flow microscopy images.Biotechnology and bioengineering · 2020Article
- Immunogenicity of Bioproducts: Cellular Models to Evaluate the Impact of Therapeutic Antibody Aggregates.Frontiers in immunology · 2020Review
- Impact of a Heat Shock Protein Impurity on the Immunogenicity of Biotherapeutic Monoclonal Antibodies.Pharmaceutical research · 2019Article
- Optimization of Sequence, Display, and Mode of Operation of IgG-Binding Peptide Ligands to Develop Robust, High-Capacity Affinity Adsorbents That Afford High IgG Product Quality.International journal of molecular sciences · 2019Article
- Evaluation ofFrontiers in immunology · 2019Article
- Flow Microscopy Imaging Is Sensitive to Characteristics of Subvisible Particles in Peginesatide Formulations Associated With Severe Adverse Reactions.Journal of pharmaceutical sciences · 2018Article
- Effect of growth hormone and IgG aggregates on dendritic cells activation and T-cells polarization.Immunology and cell biology · 2017Article
- Editor's Highlight: Subvisible Aggregates of Immunogenic Proteins Promote a Th1-Type Response.Toxicological sciences : an official journal of the Society of Toxicology · 2016Article
- Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges.Journal of pharmaceutical sciences · 2016Review
- Posttranslational Modifications and the Immunogenicity of Biotherapeutics.Journal of immunology research · 2016Review
- Evaluation of Microflow Digital Imaging Particle Analysis for Sub-Visible Particles Formulated with an Opaque Vaccine Adjuvant.PloS one · 2016Article
- Comparative Evaluation of Two Methods for Preparative Fractionation of Proteinaceous Subvisible Particles--Differential Centrifugation and FACS.Pharmaceutical research · 2015Article
- The immunogenicity of antibody aggregates in a novel transgenic mouse model.Pharmaceutical research · 2015Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe potential contribution of protein aggregates to the unwanted immunogenicity of protein pharmaceuticals is a major concern. In the present study a murine monoclonal antibody was utilized to study the immunogenicity of different types of aggregates in mice. Samples containing defined types of aggregates were prepared by processes such as stirring, agitation, exposure to ultraviolet (UV) light and exposure to elevated temperatures.
methodsAggregates were analyzed by size-exclusion chromatography, light obscuration, turbidimetry, infrared (IR) spectroscopy and UV spectroscopy. Samples were separated into fractions based on aggregate size by asymmetrical flow field-flow fractionation or by centrifugation. Samples containing different types and sizes of aggregates were subsequently administered to C57BL/6 J and BALB/c mice, and serum was analyzed for the presence of anti-IgG1, anti-IgG2a, anti-IgG2b and anti-IgG3 antibodies. In addition, the pharmacokinetic profile of the murine antibody was investigated.
resultsIn this study, samples containing high numbers of different types of aggregates were administered in order to challenge the in vivo system. The magnitude of immune response depends on the nature of the aggregates. The most immunogenic aggregates were of relatively large and insoluble nature, with perturbed, non-native structures.
conclusionThis study shows that not all protein drug aggregates are equally immunogenic.
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