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They point to the fact that FDA-approved biologic drugs carry comparable immunogenicity risks that are accepted under clinical monitoring

[DOI] [PubMed] [Google Scholar] 83.Tkalcevi V.I., Cuzi S., Brajsa K., Mildner B., Bokuli A., Situm K., Perovi D., Glojnari I., Parnham M.J

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Over 12 weeks, it can be as high as 10%

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Every batch is subjected to strict quality control, including mass spectrometry, HPLC purity verification, and sterility screening (if applicable)