Comparison of assay formats used for the detection of pre-existing anti-drug antibodies against monoclonal antibodies
Author:
Affiliation:
1. Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Bioanalysis & Biomarkers, Roche Innovation Center Munich, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany
Abstract
Funder
F. Hoffmann-La Roche
Publisher
Future Science Ltd
Subject
Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry
Link
https://www.future-science.com/doi/pdf/10.4155/bio-2022-0085
Reference14 articles.
1. Pre-Existing Biotherapeutic-Reactive Antibodies: Survey Results Within the American Association of Pharmaceutical Scientists
2. Cross-reactive and pre-existing antibodies to therapeutic antibodies—Effects on treatment and immunogenicity
3. European Medicines Agency. Guideline on immunogenicity assessment of therapeutic proteins (2017). https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf
4. US Food and Drug Administration. Immunogenicity testing of therapeutic protein products – developing and validating assays for anti-drug antibody detection (2019). https://www.fda.gov/media/119788/download
5. Novel drug and soluble target tolerant antidrug antibody assay for therapeutic antibodies bearing the P329G mutation
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1. Preclinical Observations of Systemic and Ocular Antidrug Antibody Response to Intravitreally Administered Drugs;The AAPS Journal;2022-11-22
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