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PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
Kavita U, Sun K, Braun M, Lembke W, Mody H, Kamerud J, Yang TY, Braun IV, Fang X, Gao W, Gupta S, Hofer M, Liao MZ, Loo L, McBlane F, Menochet K, Stubenrauch KG, Upreti VV, Vigil A, Wiethoff CM, Xia CQ, Zhu X, Jawa V, Chemuturi N. Kavita U, et al. Among authors: stubenrauch kg. AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1. AAPS J. 2023. PMID: 37523051 Review.
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Gupta S, Richards S, Amaravadi L, Piccoli S, Desilva B, Pillutla R, Stevenson L, Mehta D, Carrasco-Triguero M, Neely R, Partridge M, Staack RF, Zhao X, Gorovits B, Kolaitis G, Sumner G, Stubenrauch KG, Zou L, Amur S, Beaver C, Berger I, Berisha F, Birnboeck H, Bower J, Cho SJ, Cludts I, Cocea L, Donato LD, Fischer S, Fraser S, Garofolo F, Haidar S, Haulenbeek J, Hottenstein C, Hu J, Ishii-Watabe A, Islam R, Jani D, Kadavil J, Kamerud J, Kramer D, Kurki P, MacMannis S, McNally J, Mullan A, Papadimitriou A, Pedras-Vasconcelos J, Ray S, Safavi A, Saito Y, Savoie N, Fjording MS, Scheibner K, Smeraglia J, Song A, Stouffer B, Tampal N, der Strate BV, Verch T, Welink J, Xu Y, Yang TY, Yengi L, Zeng J, Zhang Y, Zhang Y, Zoog S. Gupta S, et al. Among authors: stubenrauch kg. Bioanalysis. 2017 Dec;9(24):1967-1996. doi: 10.4155/bio-2017-4974. Epub 2017 Dec 5. Bioanalysis. 2017. PMID: 29205064 Free article.
Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.
Yang TY, Braun M, Lembke W, McBlane F, Kamerud J, DeWall S, Tarcsa E, Fang X, Hofer L, Kavita U, Upreti VV, Gupta S, Loo L, Johnson AJ, Chandode RK, Stubenrauch KG, Vinzing M, Xia CQ, Jawa V. Yang TY, et al. Among authors: stubenrauch kg. Mol Ther Methods Clin Dev. 2022 Aug 2;26:471-494. doi: 10.1016/j.omtm.2022.07.018. eCollection 2022 Sep 8. Mol Ther Methods Clin Dev. 2022. PMID: 36092368 Free PMC article. Review.
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Sumner G, Keller S, Huleatt J, Staack RF, Wagner L, Azadeh M, Bandukwala A, Cao L, Du X, Salinas GF, Garofolo F, Harris S, Hopper S, Irwin C, Ji Q, Joseph J, King L, Kinhikar A, Lu Y, Luo R, Mabrouk O, Malvaux L, Marshall JC, McGuire K, Mikol V, Neely R, Qiu X, Saito Y, Salaun B, Scully I, Smeraglia J, Solstad T, Stoop J, Tang H, Teixeira P, Wang Y, Wright M, Mendez L, Beaver C, Eacret J, Au-Yeung A, Decman V, Dessy F, Eck S, Goihberg P, Alcaide EG, Gonneau C, Grugan K, Hedrick MN, Kar S, Sehra S, Stevens E, Stevens C, Sun Y, McCush F, Williams L, Fischer S, Wu B, Jordan G, Burns C, Cludts I, Coble K, Grimaldi C, Henderson N, Joyce A, Lotz G, Lu Y, Luo L, Neff F, Sperinde G, Stubenrauch KG, Wang Y, Ware M, Xu W. Sumner G, et al. Among authors: stubenrauch kg. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363 Free article.
Managing the Impact of Immunogenicity in an Era of Immunotherapy: From Bench to Bedside.
Bray-French K, Hartman K, Steiner G, Marban-Doran C, Bessa J, Campbell N, Martin-Facklam M, Stubenrauch KG, Solier C, Singer T, Ducret A. Bray-French K, et al. Among authors: stubenrauch kg. J Pharm Sci. 2021 Jul;110(7):2575-2584. doi: 10.1016/j.xphs.2021.03.027. Epub 2021 Apr 1. J Pharm Sci. 2021. PMID: 33812888 Free article. Review.
25 results