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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: nowocin a. Bioanalysis. 2025 Nov;17(22):1365-1409. doi: 10.1080/17576180.2025.2586976. Epub 2026 Jan 6. Bioanalysis. 2025. PMID: 41492841
Inhibition of thrombin on endothelium enhances recruitment of regulatory T cells during IRI and when combined with adoptive Treg transfer, significantly protects against acute tissue injury and prolongs allograft survival.
Peng Q, Nowocin A, Ratnasothy K, Smith RA, Smyth LA, Lechler RI, Dorling A, Lombardi G. Peng Q, et al. Among authors: nowocin a. Front Immunol. 2023 Jan 30;13:980462. doi: 10.3389/fimmu.2022.980462. eCollection 2022. Front Immunol. 2023. PMID: 36793549 Free PMC article.
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