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Developability considerations for bispecific and multispecific antibodies. | LitMetric

AI Article Synopsis

  • Bispecific antibodies (bsAbs) and multispecific antibodies (msAbs) can target multiple regions on a disease-causing agent, offering new treatment options for hard-to-treat diseases.
  • Early evaluation of these antibodies helps identify the ones with the highest potential for development, while dismissing those that are less promising.
  • Key factors such as molecular structure, risk of immune response, specificity, stability, and production capacity must be carefully assessed to ensure these therapies meet competitive standards.

Article Abstract

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.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11352713PMC
http://dx.doi.org/10.1080/19420862.2024.2394229DOI Listing

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