ArticleMethods in molecular biology (Clifton, N.J.)2011
In vitro immunogenicity risk assessment of therapeutic proteins in preclinical setting.
Article in Methods in molecular biology (Clifton, N.J.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed.
- Immunogenicity risk assessment of empty capsids present in adeno-associated viral vectors using predictive innate immune responses.Journal of pharmaceutical 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
- Immune regulatory adjuvant approach to mitigate subcutaneous immunogenicity of monoclonal antibodies.Frontiers in immunology · 2024Article
- Effect of Biophysical Properties of Phosphatidylserine Particle on Immune Tolerance Induction Toward Factor VIII in a Hemophilia A Mouse Model.Journal of pharmaceutical sciences · 2016Article
- Phosphatidylserine Converts Immunogenic Recombinant Human Acid Alpha-Glucosidase to a Tolerogenic Form in a Mouse Model of Pompe Disease.Journal of pharmaceutical sciences · 2016Article
- Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational Modifications.Journal of immunology research · 2016Review
- Unraveling the Effect of Immunogenicity on the PK/PD, Efficacy, and Safety of Therapeutic Proteins.Journal of immunology research · 2016Review
- Physical characterization and in vitro biological impact of highly aggregated antibodies separated into size-enriched populations by fluorescence-activated cell sorting.Journal of pharmaceutical sciences · 2015Article
- Immunogenicity of therapeutic proteins: influence of aggregation.Journal of immunotoxicologyReview
- Article
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
Immunogenicity against therapeutic proteins is a clinical problem in the successful treatment of many diseases and, as such, immunogenicity risk assessment in preclinical setting would be useful to improve safety and efficacy of protein-based therapeutics in the product development stages. Here, we attempted a mechanism-based in vitro study as screening tool to capture clinically observed antibody-based immune response against two representative therapeutic proteins: recombinant human Erythropoietin-alpha (rHuEPO)and recombinant Factor VIII (rFVIII). Flow-cytometry was used to determine the maturation level of dendritic cells (DCs), a primary initiator of T-cell responses. Studies to capture T-lymphocyte proliferation upon challenge with free rFVIII were performed and secretion of immunomodulatory cytokines was analyzed by ELISA assay. These in vitro techniques could be used as risk assessment tool to determine the immunogenic potential of formulations of recombinant proteins in preclinical setting.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.