单克隆抗体
药品
抗体
同型
免疫系统
药物开发
计算生物学
免疫学
药理学
医学
生物
作者
Alexander Pöhler,Thomas Emrich,Gregor Jordan,Martin Schäfer,Kay-Gunnar Stubenrauch,Roland F. Staack,Carolin Zach,Julian Meir,Janine Faigle
出处
期刊:Bioanalysis
[Newlands Press Ltd]
日期:2022-07-01
卷期号:14 (13): 923-933
被引量:1
标识
DOI:10.4155/bio-2022-0085
摘要
Aim: Assessment of pre-existing anti-drug antibody (preADA) reactivity at early drug development stages can be beneficial for candidate selection. We investigated the applicability of a generic immune-complex anti-drug antibody (ADA) assay for early preADA assessment as an easily available alternative to the commonly used ADA bridging assay. Results: The results confirmed the expected assay difference regarding isotype detectability. Tested drug candidates were identified as preADA-reactive using the immune-complex ADA assay despite its limitation of not being able to detect IgM-type preADAs. Conclusion: We recommend a purpose-driven use of the two assay formats. For the purpose of ranking different Pro329Gly mutation-bearing drug candidates, the immune-complex ADA assay is preferred in the phase before selecting a drug for clinical development.
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