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In vitro assays for assessing the immunogenicity risks may be acceptable approaches, if they are well validated, optimized, and are suitable for use.

[DOI] [PubMed] [Google Scholar] 109.Sikiric P., Seiwerth S., Rucman R., Turkovic B., Rokotov D.S., Brcic L., Sever M., Klicek R., Radic B., Drmic D., et al

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If effective, the application can be repeated every three months