ArticleThe Journal of biological chemistry2011
Classification and characterization of therapeutic antibody aggregates.
Article in The Journal of biological chemistry, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 102 papers, 1 of them a synthesis that pooled it.
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Who cites it
102 citing papers in PubMed, 1 synthesis or guideline pooled it.
- T-Cell Dependent Immunogenicity of Protein Therapeutics Pre-clinical Assessment and Mitigation-Updated Consensus and Review 2020.Frontiers in immunology · 2020Pooled it
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- Screening of Unexplored FDA-approved Inactive Ingredients as Stabilizers for Monoclonal Antibody Products.Pharmaceutical research · 2026Article
- Optical imaging and spectroscopic characterization of subvisible particles in protein therapeutics.Advanced drug delivery reviews · 2026Review
- Mechanisms of therapeutic antibodies immunogenicity: infliximab oligomeric aggregates increase T-cell response and uptake by dendritic cells involving mannose-sensitive receptor CD206.Frontiers in immunology · 2026Article
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- Utility of anLab on a chip · 2025Article
- Analytical strategies for identification and quantitation of heterodimers in co-formulated monoclonal antibody cocktails by native SEC-MS.Scientific reports · 2025Article
- Highly variable aggregation and glycosylation profiles and their roles in immunogenicity to protein-based therapeutics.Journal of pharmaceutical sciences · 2025Review
- Impact of Various Forced Oxidative Stress Factors in Rapid Degradation of mAb: Trastuzumab as a Case Study.Pharmaceutical research · 2025Article
- Immunogenicity risk assessment and mitigation for engineered antibody and protein therapeutics.Nature reviews. Drug discovery · 2024Review
- Exposure to Silicone Oil Endotamponades Induces VEGF Antibody Aggregation and Loss of Functionality.Investigative ophthalmology & visual science · 2024Article
- Submicron immunoglobulin particles exhibit FcγRII-dependent toxicity linked to autophagy in TNFα-stimulated endothelial cells.Cellular and molecular life sciences : CMLS · 2024Article
- In-Depth Characterization for Methionine Oxidization in Complementary Domain Region by Hydrophobic Interaction Chromatography.ACS pharmacology & translational science · 2024Article
- Article
- Unraveling the Impact of Extracellular Vesicle-Depleted Serum on Endothelial Cell Characteristics over Time.International journal of molecular sciences · 2024Article
- A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic.Pharmaceutical research · 2024Article
- Taurine, a Naturally Occurring Amino Acid, as a Physical Stability Enhancer of Different Monoclonal Antibodies.The AAPS journal · 2024Article
- Visible particles in parenteral drug products: A review of current safety assessment practice.Current research in toxicology · 2024Article
- Discovery and Characterization of an Acid-Labile Serine-Lysine Cross-Link in Antibody High-Molecular-Weight Species Using a Multipronged Mass Spectrometry Approach.Analytical chemistry · 2023Article
42 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A host of diverse stress techniques was applied to a monoclonal antibody (IgG(2)) to yield protein particles with varying attributes and morphologies. Aggregated solutions were evaluated for percent aggregation, particle counts, size distribution, morphology, changes in secondary and tertiary structure, surface hydrophobicity, metal content, and reversibility. Chemical modifications were also identified in a separate report (Luo, Q., Joubert, M. K., Stevenson, R., Narhi, L. O., and Wypych, J. (2011) J. Biol. Chem. 286, 25134-25144). Aggregates were categorized into seven discrete classes, based on the traits described. Several additional molecules (from the IgG(1) and IgG(2) subtypes as well as intravenous IgG) were stressed and found to be defined with the same classification system. The mechanism of protein aggregation and the type of aggregate formed depends on the nature of the stress applied. Different IgG molecules appear to aggregate by a similar mechanism under the same applied stress. Aggregates created by harsh mechanical stress showed the largest number of subvisible particles, and the class generated by thermal stress displayed the largest number of visible particles. Most classes showed a disruption of the higher order structure, with the degree of disorder depending on the stress process. Particles in all classes (except thermal stress) were at least partially reversible upon dilution in pH 5 buffer. High copper content was detected in isolated metal-catalyzed aggregates, a stress previously shown to produce immunogenic aggregates. In conclusion, protein aggregates can be a very heterogeneous population, whose qualities are the result of the type of stress that was experienced.
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