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.
US Department of Health & Human Services, Food & Drug Administration. Guidance for industry: immunogenicity assessment for therapeutic protein products. 2014.
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.
Article CAS PubMed Google Scholar
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.
Article CAS PubMed Google Scholar
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.
Article CAS PubMed Google Scholar
Jawa V, Maamary J, Swanson M, Zhang S, Montgomery D. Implementing a clinical immunogenicity strategy using preclinical risk assessment outputs. J Pharm Sci. 2022;111(4):960–9.
Article CAS PubMed Google Scholar
Attermann AS, Barra C, Reynisson B, Schultz HS, Leurs U, Lamberth K, et al. Improved prediction of HLA antigen presentation hotspots: applications for immunogenicity risk assessment of therapeutic proteins. Immunology. 2021;162(2):208–19.
Article CAS PubMed Google Scholar
Gorovits B, Wakshull E, Pilluta R, Xu Y, Manning MS, Goyal J. Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics. J Immunol Methods. 2014;408:1–12.
Article CAS PubMed Google Scholar
Centers of Excellence in Regulatory Science (CERSI) and Food and Drug Administration (FDA) collaborative workshop: Predictive immunogenicity for Better Clincial Outcomes. 2018. https://cersi.umd.edu/immunogenicity
Food & Drug Administration. Guidance for industry: immunogenicity testing of therapeutic protein products—developing and validating assays for anti-drug antibody detection. Rockville: US Food and Drug Administration; 2019.
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.
Article CAS PubMed Google Scholar
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.
Chamberlain P, Rup B. Immunogenicity risk assessment for an engineered human cytokine analogue expressed in different cell substrates. AAPS J. 2020;22(3):65.
Article CAS PubMed Google Scholar
Sperinde G, Montgomery D, Mytych DT. Clinical immunogenicity risk assessment for a fusion protein. AAPS J. 2020;22(3):64.
Article CAS PubMed Google Scholar
Kroenke MA, Milton MN, Kumar S, Bame E, White JT. Immunogenicity risk assessment for multi-specific therapeutics. AAPS J. 2021;23(6):115.
Article CAS PubMed Google Scholar
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.
留言 (0)