免疫原性
抗体
药品
重组DNA
单克隆抗体
化学
药物发现
药物开发
药代动力学
计算生物学
药理学
生物
免疫学
生物化学
基因
作者
Stefan Harth,Christian Frisch
出处
期刊:Methods in molecular biology
日期:2021-01-01
卷期号:: 291-306
被引量:2
标识
DOI:10.1007/978-1-0716-1186-9_18
摘要
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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