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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Main Authors: | , , , , |
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Format: | Article |
Language: | English |
Published: |
Taylor & Francis Group
2025-12-01
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Series: | mAbs |
Subjects: | |
Online Access: | https://www.tandfonline.com/doi/10.1080/19420862.2025.2458627 |
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