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Editorial
. 2023 Apr 20;25(3):43.
doi: 10.1208/s12248-023-00796-4.

The AAPS Journal Theme Issue: Compendium of Immunogenicity Risk Assessments: an Industry Guidance Built on Experience and Published Work

Johanna R Mora  1 , Susan M Richards  2
Affiliations
Editorial

The AAPS Journal Theme Issue: Compendium of Immunogenicity Risk Assessments: an Industry Guidance Built on Experience and Published Work

Johanna R Mora et al. AAPS J. .
No abstract available

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References

    1. Rosenberg A, Worobec A. A risk-based approach to immunogenicity concerns of therapeutic protein products, Part 1: considering consequences of the immune response to a protein. BioPharm Int. 2004;17:34–42.
    1. US Department of Health & Human Services, Food & Drug Administration. Guidance for industry: immunogenicity assessment for therapeutic protein products. 2014.
    1. Yin L, Chen X, Vicini P, Rup B, Hickling T. Therapeutic outcomes, assessments, risk facotrs and mitigation efforts of immunogniecity of therapeutic protein products. Cell Immunol. 2015;295:118–26. - DOI - PubMed
    1. Wickramarachchi D, Steeno G, You Z, Shaik S, Lepsy C, Xue L. Fit-for-purpose validation and establishment of assay acceptance and reporting criteria of dendritic cell activation assay contributing to the assessment of immunogenicity risk. AAPS J. 2020;22(5):114. - DOI - PubMed
    1. Steiner G, Marban-Doran C, Langer J, Pimenova T, Duran-Pacheco G, Sauter D, et al. Enabling routine MHC-II-associated peptide proteomics for risk assessment of drug-induced immunogenicity. J Proteome Res. 2020;19(9):3792–806. - DOI - PubMed

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