Abstract
Sensitive and reproducible pharmacokinetic (PK) assays and immunogenicity assessment are required as part of the complex and lengthy development process for biotherapeutic proteins. Ligand binding assays (LBAs) are included in a range of approaches applied to understand the nature and properties of the drug as well as the induction of anti-drug antibodies (ADA) against the therapeutic, which can cause adverse events and loss of efficacy. Currently, most biotherapeutics are monoclonal human or humanized antibodies. Anti-idiotypic antibodies, targeting the idiotopic determinants of individual antibody drugs are recognized as perfect reagents for such LBAs. Here we describe the typical setups for these assays and how different types of anti-biotherapeutic antibodies can be used to establish selective and sensitive assays.
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We thank Amanda Turner and Achim Knappik for carefully reading the manuscript. All images are reprinted with permission of Bio-Rad Laboratories Inc., Hercules, CA, USA.
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Harth, S., Frisch, C. (2021). Recombinant Anti-idiotypic Antibodies in Ligand Binding Assays for Antibody Drug Development. In: Posch, A. (eds) Proteomic Profiling. Methods in Molecular Biology, vol 2261. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-1186-9_18
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DOI: https://doi.org/10.1007/978-1-0716-1186-9_18
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