Establishing endotoxin limits to enhance the reliability of in vitro immunogenicity risk assessments

Establishing endotoxin limits to enhance the reliability of in vitro immunogenicity risk assessments

Immunogenic responses to biotherapeutics often lead to termination of their development because the resulting anti-drug-antibodies (ADA) can negatively impact pharmacology, safety, and efficacy. To mitigate ADA risks, in vitro risk assessment assays in non-clinical settings are essential to enhance...

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Bibliographic Details
Main Authors: Yun Hee Jeong, Gillian Lennon, Geertruida Veldman, Daniel M. Serna, Alexander Ibrahimov
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:mAbs
Subjects:
Endotoxin
in vitro assay
immunogenicity risk assessment
T cell proliferation
Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2025.2458627
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