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, 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
Subjects:
Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2024.2394229
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author Alaa Amash
Gesa Volkers
Patrick Farber
Daniel Griffin
K. Shawn Davison
Allison Goodman
Raffi Tonikian
Aaron Yamniuk
Bryan Barnhart
Tim Jacobs
author_facet Alaa Amash
Gesa Volkers
Patrick Farber
Daniel Griffin
K. Shawn Davison
Allison Goodman
Raffi Tonikian
Aaron Yamniuk
Bryan Barnhart
Tim Jacobs
author_sort Alaa Amash
collection DOAJ
description 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.
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institution Kabale University
issn 1942-0862
1942-0870
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publishDate 2024-12-01
publisher Taylor & Francis Group
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series mAbs
spelling doaj-art-020fa653c746460f9979c68b5e356aea2025-01-31T04:19:38ZengTaylor & Francis GroupmAbs1942-08621942-08702024-12-0116110.1080/19420862.2024.2394229Developability considerations for bispecific and multispecific antibodiesAlaa Amash0Gesa Volkers1Patrick Farber2Daniel Griffin3K. Shawn Davison4Allison Goodman5Raffi Tonikian6Aaron Yamniuk7Bryan Barnhart8Tim Jacobs9AbCellera Biologics Inc, Vancouver, BC, CanadaAbCellera Biologics Inc, Vancouver, BC, CanadaAbCellera Biologics Inc, Vancouver, BC, CanadaAbCellera Biologics Inc, Vancouver, BC, CanadaAbCellera Biologics Inc, Vancouver, BC, CanadaAbCellera Biologics Inc, Vancouver, BC, CanadaAbCellera Biologics Inc, Vancouver, BC, CanadaAbCellera Biologics Inc, Vancouver, BC, CanadaAbCellera Biologics Inc, Vancouver, BC, CanadaAbCellera Biologics Inc, Vancouver, BC, CanadaBispecific 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.https://www.tandfonline.com/doi/10.1080/19420862.2024.2394229Antibodybispecificdevelopabilityformatimmunogenicitymanufacturability
spellingShingle Alaa Amash
Gesa Volkers
Patrick Farber
Daniel Griffin
K. Shawn Davison
Allison Goodman
Raffi Tonikian
Aaron Yamniuk
Bryan Barnhart
Tim Jacobs
Developability considerations for bispecific and multispecific antibodies
mAbs
Antibody
bispecific
developability
format
immunogenicity
manufacturability
title Developability considerations for bispecific and multispecific antibodies
title_full Developability considerations for bispecific and multispecific antibodies
title_fullStr Developability considerations for bispecific and multispecific antibodies
title_full_unstemmed Developability considerations for bispecific and multispecific antibodies
title_short Developability considerations for bispecific and multispecific antibodies
title_sort developability considerations for bispecific and multispecific antibodies
topic Antibody
bispecific
developability
format
immunogenicity
manufacturability
url https://www.tandfonline.com/doi/10.1080/19420862.2024.2394229
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