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    Establishing endotoxin limits to enhance the reliability of in vitro immunogenicity risk assessments by Yun Hee Jeong, Gillian Lennon, Geertruida Veldman, Daniel M. Serna, Alexander Ibrahimov

    Published 2025-12-01
    “…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 safety and efficacy of protein-based therapeutics. …”
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