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

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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.

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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.

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The European Agency for the Evaluation of Medicinal Products (EMA). Guideline on immunogenicity assessment of therapeutic proteins. (EMEA/CHMP/BMWP/14327/2006 Rev. 1). 2017.

Mora JR, White JT, DeWall SL. Immunogenicity risk assessment for PEGylated therapeutics. AAPS J. 2020;22(2):35.

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Kernstock R, Sperinde G, Finco D, Davis R, Montgomery D. Clinical immunogenicity risk assessment strategy for a low-risk monoclonal antibody. AAPS J. 2020;22(3):60.

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Chamberlain P, Rup B. Immunogenicity risk assessment for an engineered human cytokine analogue expressed in different cell substrates. AAPS J. 2020;22(3):65.

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Sperinde G, Montgomery D, Mytych DT. Clinical immunogenicity risk assessment for a fusion protein. AAPS J. 2020;22(3):64.

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Kroenke MA, Milton MN, Kumar S, Bame E, White JT. Immunogenicity risk assessment for multi-specific therapeutics. AAPS J. 2021;23(6):115.

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Henry SP, Arfidsson C, Arrington J, Canadi J, Crowe D, Gupta S, Lohmann S, Massonnet B, Mytych D, Rogers T, Rogers H, Stebbins C, Stovold C, Verthelyi D, Vigil A, Xuan C, Xu Y, Yu R, Klem T. Assessment of the immunogenicity potential for oligonucleotide-based drugs. Nucleic Acid Ther. 2022;2022(32):369–77.

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