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Anti-drug Antibody Sample Testing and Reporting Harmonization.
Jani D, Marsden R, Gunsior M, Hay LS, Ward B, Cowan KJ, Azadeh M, Barker B, Cao L, Closson KR, Coble K, Dholakiya SL, Dusseault J, Hays A, Herl C, Hodsdon ME, Irvin SC, Kirshner S, Kolaitis G, Kulagina N, Kumar S, Lai CH, Lipari F, Liu S, Merdek KD, Moldovan IR, Mozaffari R, Pan L, Place C, Snoeck V, Manning MS, Stocker D, Tary-Lehmann M, Turner A, Vainshtein I, Verthelyi D, Williams WT, Yan H, Yan W, Yang L, Yang L, Zemo J, Zhong ZD. Jani D, et al. Among authors: mozaffari r. AAPS J. 2022 Oct 28;24(6):113. doi: 10.1208/s12248-022-00762-6. AAPS J. 2022. PMID: 36307592
Neutralizing Antibody Sample Testing and Report Harmonization.
Jani D, Gunsior M, Marsden R, Cowan KJ, Irvin SC, Hay LS, Ward B, Armstrong L, Azadeh M, Cao L, Carmean R, DelCarpini J, Dholakiya SL, Hays A, Hosback S, Hu Z, Kulagina N, Kumar S, Lai CH, Lichtfuss M, Liu HY, Liu S, Mozaffari R, Pan L, Pennucci J, Poupart ME, Saini G, Snoeck V, Storey K, Turner A, Vainshtein I, Verthelyi D, Wala I, Yang L, Yang L. Jani D, et al. Among authors: mozaffari r. AAPS J. 2024 Jul 12;26(4):80. doi: 10.1208/s12248-024-00955-1. AAPS J. 2024. PMID: 38992280
Correction to: Neutralizing Antibody Sample Testing and Report Harmonization.
Jani D, Gunsior M, Marsden R, Cowan KJ, Irvin SC, Hay LS, Ward B, Armstrong L, Azadeh M, Cao L, Carmean R, DelCarpini J, Dholakiya SL, Hays A, Hosback S, Hu Z, Kulagina N, Kumar S, Lai CH, Lichtfuss M, Liu HY, Liu S, Mozaffari R, Pan L, Pennucci J, Poupart ME, Saini G, Snoeck V, Storey K, Turner A, Vainshtein I, Verthelyi D, Wala I, Yang L, Yang L. Jani D, et al. Among authors: mozaffari r. AAPS J. 2024 Sep 4;26(5):98. doi: 10.1208/s12248-024-00965-z. AAPS J. 2024. PMID: 39231893 No abstract available.
2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS (PART 3A - Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).
Tounekti O, Shubow S, Wassmer S, Van Tuyl A, Yang L, Gong B, Abhari MR, Kalina W, Myler H, DelCarpini J, Escobar D, Fiscella M, Gorovits B, Gupta S, Irvin SC, Irwin C, Jankowski W, Jawa V, Karauzum H, Kerridge C, Lu Y, Mayer C, McGregor J, Melton A, Murphy R, Nanra J, Nowocin A, Partridge MA, Prior S, Sauna Z, Scott B, Seitzer J, Stern M, Sugimoto H, Taylor M, Wong A, Xiao W, Xu Y, Yang TY, Yuill D, Kubiak RJ, Thway T, Gunn G, Pelto R, Sumner G, Baltrukonis D, Dholakiya SL, Dogmanits S, Garofolo F, Jadhav M, Kramer D, Meyer E, Mohapatra S, Mozaffari R, Peng K, Pine S, Poetzl J, Rasamoelisolo M, Shao W, Staack RF, Swanson S, Taqui A, Vauleon S, Wang Y, Wen Y. Tounekti O, et al. Among authors: mozaffari r. Bioanalysis. 2025 Nov;17(22):1365-1409. doi: 10.1080/17576180.2025.2586976. Epub 2026 Jan 6. Bioanalysis. 2025. PMID: 41492841