Luo, Shen https://orcid.org/0000-0002-1912-6741
Hess, Kayla https://orcid.org/0000-0002-6508-4423
Rogstad, Sarah https://orcid.org/0000-0002-8998-053X
Zhang, Baolin https://orcid.org/0000-0002-7859-0843
Article History
Received: 24 October 2025
Accepted: 7 January 2026
First Online: 23 January 2026
Declarations
: AI was used solely to improve language, grammar, and clarity; all scientific content and conclusions were generated by the authors.
: The views expressed in this article are those of the author and are based on analysis of glycosylation data in the regulatory submissions for therapeutic antibodies. They should not be construed as FDA’s views or policies.
: No potential conflicts of interest were disclosed.