Developability considerations for bispecific and multispecific antibodies

Bispecific antibodies (bsAb) and multispecific antibodies (msAb) encompass a diverse variety of formats that can concurrently bind multiple epitopes, unlocking mechanisms to address previously difficult-to-treat or incurable diseases. Early assessment of candidate developability enables demotion of...

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Bibliographic Details
Main Authors: Alaa Amash, Gesa Volkers, Patrick Farber, Daniel Griffin, K. Shawn Davison, Allison Goodman, Raffi Tonikian, Aaron Yamniuk, Bryan Barnhart, Tim Jacobs
Format: Article
Language:English
Published: Taylor & Francis Group 2024-12-01
Series:mAbs
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Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2024.2394229
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Summary:Bispecific antibodies (bsAb) and multispecific antibodies (msAb) encompass a diverse variety of formats that can concurrently bind multiple epitopes, unlocking mechanisms to address previously difficult-to-treat or incurable diseases. Early assessment of candidate developability enables demotion of antibodies with low potential and promotion of the most promising candidates for further development. Protein-based therapies have a stringent set of developability requirements in order to be competitive (e.g. high-concentration formulation, and long half-life) and their assessment requires a robust toolkit of methods, few of which are validated for interrogating bsAbs/msAbs. Important considerations when assessing the developability of bsAbs/msAbs include their molecular format, likelihood for immunogenicity, specificity, stability, and potential for high-volume production. Here, we summarize the critical aspects of developability assessment, and provide guidance on how to develop a comprehensive plan tailored to a given bsAb/msAb.
ISSN:1942-0862
1942-0870