The immunogenicity of mAbs is a significant safety issue, however the predictivity of animal choices for evaluation of immunogenicity is low as clearly stated in the recent EMEA guideline over the immunogenicity assessment of biotechnology-derived therapeutic proteins

The immunogenicity of mAbs is a significant safety issue, however the predictivity of animal choices for evaluation of immunogenicity is low as clearly stated in the recent EMEA guideline over the immunogenicity assessment of biotechnology-derived therapeutic proteins.52 Apart from evaluating closely related products (e.g., biosimilars), obtainable pet choices can’t be likely to provide relevant information […]

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