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:
Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2025.2458627
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