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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Main Authors: Alaa Amash (Author), Gesa Volkers (Author), Patrick Farber (Author), Daniel Griffin (Author), K. Shawn Davison (Author), Allison Goodman (Author), Raffi Tonikian (Author), Aaron Yamniuk (Author), Bryan Barnhart (Author), Tim Jacobs (Author)
Format: Book
Published: Taylor & Francis Group, 2024-12-01T00:00:00Z.
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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.
Item Description:10.1080/19420862.2024.2394229
1942-0870
1942-0862