Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products

The AAPS Journal 2026 Open access

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Authors: Jennifer Lee, Hana Lee, Sudhir Agrawal, Joseph A. Balsamo, Andrew Clerman, Sofie Denies, Anne Searls De Groot, Jeremy W. Fry, Nicolas Gaudenzio, Andrew J. Graves, Kristina E. Howard, SuJin Hwang
+33 more Vibha Jawa, Yafei Jin, Logan Kelley-Baker, Emilee R. Knowlton, Filip Kolenc, Kirthiram Krishnaveni Sivakumar, Jae Ho Lee, Yili Li, Likan Liang, D. T. Y. LIU, Yanyan Liu, Robert A. Lionberger, Markham C. Luke, Mohanraj Manangeeswaran, Mirian I. Mendoza, Iilun Murphy, Michael A. Norcross, James E. Polli, Montserrat Puig, Narasimha Rao SP, Hobart L. Rogers, Anna A. Schwendeman, Robert W. Siegel, Sophie Shubow, Noel Smith, Seth G. Thacker, Sophie Tourdot, Kui Yang, Li Zhang, Deyi Zhang, Cameron J. Smith, Eric S. Pang, Daniela I. Verthelyi
DOI: 10.1208/s12248-025-01164-0
Cited by: 0
References: 13

Fields of Study & Subjects

Biosimilars and Bioanalytical Methods Pharmaceutical Economics and Policy vaccines and immunoinformatics approaches

Publication details

Journal / source
The AAPS Journal
Volume
28
Issue
2
Pages
61–61
Publication date
12 February 2026
Language
EN