ArticlePharmaceutical research2012
Detection and characterization of subvisible aggregates of monoclonal IgG in serum.
Article in Pharmaceutical research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
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Who cites it
25 citing papers in PubMed.
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- Impact of Various Forced Oxidative Stress Factors in Rapid Degradation of mAb: Trastuzumab as a Case Study.Pharmaceutical research · 2025Article
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- Image Analysis Algorithm-Based Platform for Determining Micron and Higher Aggregate Size Distribution of Therapeutic IgG Using Brightfield and Fluorescence Microscope Images.Pharmaceutical research · 2021Article
- Novel semi-automated fluorescence microscope imaging algorithm for monitoring IgG aggregates in serum.Scientific reports · 2021Article
- Assessment of Antibody Stability in a Novel Protein-Free Serum Model.Pharmaceutics · 2021Article
- Quantification of glycated IgG in CHO supernatants: A practical approach.Biotechnology progress · 2021Article
- Immunogenicity Challenges Associated with Subcutaneous Delivery of Therapeutic Proteins.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Review
- Particle Detection and Characterization for Biopharmaceutical Applications: Current Principles of Established and Alternative Techniques.Pharmaceutics · 2020Review
- In Vivo Stability of Therapeutic Proteins.Pharmaceutical research · 2020Review
- Considerations for the Design of Antibody-Based Therapeutics.Journal of pharmaceutical sciences · 2020Review
- Immune Complexes Impaired Glomerular Endothelial Cell Functions in Lupus Nephritis.International journal of molecular sciences · 2019Article
- Evaluation ofFrontiers in immunology · 2019Article
- Article
- Sizing nanomaterials in bio-fluids by cFRAP enables protein aggregation measurements and diagnosis of bio-barrier permeability.Nature communications · 2016Article
- Quantifying Trace Amounts of Aggregates in Biopharmaceuticals Using Analytical Ultracentrifugation Sedimentation Velocity: Bayesian Analyses and F Statistics.The AAPS journal · 2016Article
- Experimental Model System to Study pH Shift-Induced Aggregation of Monoclonal Antibodies Under Controlled Conditions.Pharmaceutical research · 2016Article
- Posttranslational Modifications and the Immunogenicity of Biotherapeutics.Journal of immunology research · 2016Review
- Small amounts of sub-visible aggregates enhance the immunogenic potential of monoclonal antibody therapeutics.Pharmaceutical research · 2015Article
- Quantitative laser diffraction method for the assessment of protein subvisible particles.Journal of pharmaceutical sciences · 2015Article
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo detect and characterize the aggregation of therapeutic monoclonal antibodies in undiluted biological fluids.
methodsFluorescently labeled subvisible IgG aggregates formed by applying either heat stress or by pH-shift were investigated immediately after addition to human serum, and after 24 h. Unstressed and stressed IgG formulations were analyzed by fluorescence single particle tracking, confocal laser scanning microscopy and flow cytometry.
resultsUnstressed formulations remained free from subvisible aggregates in serum, whereas heat-stressed and pH-shift stressed formulations showed dissimilar aggregation behaviors. The aggregation profile of the heat-stressed formulation diluted in serum remained practically the same as the one diluted in buffer, even after the 24 h incubation period. The pH-shift stressed formulation had strikingly smaller and more numerous subvisible aggregates immediately after dilution in serum compared to buffer. These aggregates became noticeably larger in both diluents after 24 h, but in serum they appeared to be formed by other types of constituents than the labeled protein itself.
conclusionThese results show that subvisible therapeutic protein aggregates may undergo changes in number, type and size distribution upon contact with human serum. This emphasizes the importance of analytical strategies for monitoring aggregation in undiluted biological fluids.
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