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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).

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Title: 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).
Authors: Tounekti O; Health Canada, Ottawa, Ontario, Canada., Shubow S; US FDA, Silver Spring, Maryland, United States., Wassmer S; Health Canada, Ottawa, Ontario, Canada., Van Tuyl A; AstraZeneca, Gaithersburg, Maryland, United States., Yang L; BioMarin, Novato, California, United States., Gong B; US FDA, Jefferson, Arkansas, United States., Abhari MR; Novartis, Cambridge, Massachusetts, United States., Kalina W; Pfizer, Pearl River, New York, United States., Myler H; Takeda, Yardley, Pennsylvania, United States., DelCarpini J; Moderna, Cambridge, Massachusetts, United States., Escobar D; Navigate, Carlsbad, California, United States., Fiscella M; REGENXBIO, Rockville, Maryland, United States., Gorovits B; Regeneron, Tarrytown, New York, United States., Gupta S; AbbVie, Irvine, California, United States., Irvin SC; Regeneron, Tarrytown, New York, United States., Irwin C; Health Canada, Ottawa, Ontario, Canada., Jankowski W; US FDA, Silver Spring, Maryland, United States., Jawa V; Bristol Myers Squibb, Lawrenceville, New Jersey, United States., Karauzum H; Pfizer, Pearl River, New York, United States., Kerridge C; UK MHRA, London, United Kingdom., Lu Y; Sangamo, Richmond, California, United States., Mayer C; Austria AGES/ EU EMA, Vienna, Austria., McGregor J; WRIB, Toronto, Ontario, Canada., Melton A; AstraZeneca, Gaithersburg, Maryland, United States., Murphy R; Sanofi, Swiftwater, Pennsylvania, United States., Nanra J; GSK, Cambridge, Massachusetts, United States., Nowocin A; UK MHRA, London, United Kingdom., Partridge MA; Regeneron, Tarrytown, New York, United States., Prior S; UK MHRA, London, United Kingdom., Sauna Z; US FDA, Silver Spring, Maryland, United States., Scott B; Health Canada, Ottawa, Ontario, Canada., Seitzer J; Intellia, Windham, New Hampshire, United States., Stern M; Bristol Myers Squibb, Lawrenceville, New Jersey, United States., Sugimoto H; Takeda, Cambridge, Massachusetts, United States., Taylor M; Moderna, Cambridge, Massachusetts, United States., Wong A; Health Canada, Ottawa, Ontario, Canada., Xiao W; US FDA, Silver Spring, Maryland, United States., Xu Y; Intellia, Cambridge, Massachusetts, United States., Yang TY; J&J Innovative Medicine, Spring House, Pennsylvania, United States., Yuill D; AstraZeneca, Cambridge, United Kingdom., Kubiak RJ; Third Arc Bio, Lower Gwynedd, Pennsylvania, United States., Thway T; Eisai, Nutley, New Jersey, United States., Gunn G; GSK, Collegeville, Pennsylvania, United States., Pelto R; Alexion, Higganum, Connecticut, United States., Sumner G; Regeneron, Tarrytown, New York, United States., Baltrukonis D; Pfizer, Groton, Connecticut, United States., Dholakiya SL; Bristol Myers Squibb, Lawrenceville, New Jersey, United States., Dogmanits S; GSK, Collegeville, Pennsylvania, United States., Garofolo F; BRI Frontage, Vancouver, British Columbia, Canada., Jadhav M; Novartis, Cambridge, Massachusetts, United States., Kramer D; Sanofi, Frankfurt am Main, Germany., Meyer E; GSK, Collegeville, Pennsylvania, United States., Mohapatra S; Stoke, Bedford, Massachusetts, United States., Mozaffari R; GSK, Collegeville, Pennsylvania, United States., Peng K; Genentech, South San Francisco, California, United States., Pine S; Sanofi, Zwijnaarde, Belgium., Poetzl J; Sandoz, Holzkirchen, Germany., Rasamoelisolo M; Teva, West Chester, Pennsylvania, United States., Shao W; BioMarin, Novato, California, United States., Staack RF; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany., Swanson S; Genentech, South San Francisco, California, United States., Taqui A; Gilead, Foster City, California, United States., Vauleon S; F. Hoffmann-La Roche, Basel, Switzerland., Wang Y; Lilly, Indianapolis, Indiana, United States., Wen Y; Lilly, Indianapolis, Indiana, United States.
Source: Bioanalysis [Bioanalysis] 2025 Nov; Vol. 17 (22), pp. 1365-1409. Date of Electronic Publication: 2026 Jan 06.
Publication Type: Journal Article
Journal Info: Publisher: Taylor & Francis Country of Publication: England NLM ID: 101512484 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1757-6199 (Electronic) Linking ISSN: 17576180 NLM ISO Abbreviation: Bioanalysis Subsets: MEDLINE
Database: MEDLINE Ultimate
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              Y: 2025
          Identifiers:
            – Type: issn-electronic
              Value: 1757-6199
          Numbering:
            – Type: volume
              Value: 17
            – Type: issue
              Value: 22
          Titles:
            – TitleFull: Bioanalysis
              Type: main
ResultId 1