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2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

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Title: 2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).
Authors: Tounekti O; Health Canada, Ottawa, ON, Canada., Prior S; UK MHRA, London, UK., Wassmer S; Health Canada, Ottawa, ON, Canada., Xu J; US FDA, Jefferson, AR, USA., Wong A; Health Canada, Ottawa, ON, Canada., Fang X; AskBio, Research Triangle Park, NC, USA., Sonderegger I; Takeda, Opfikon, Switzerland., Smeraglia J; AstraZeneca, Cambridge, UK., Huleatt J; Gates Medical Research Institute, Cambridge, MA, USA., Loo L; Vertex, Boston, MA, USA., Beaver C; Takeda, Cambridge, MA, USA., DelCarpini J; Moderna, Mystic, CT, USA., Dessy F; GlaxoSmithKline, Rixensart, Belgium., Diebold S; UK MHRA, London, UK., Fiscella M; REGENXBIO, Rockville, MD, USA., Garofolo F; BRI Frontage, Vancouver, BC, Canada., Grimaldi C; Regeneron, Tarrytown, NY, USA., Gupta S; AbbVie, Irvine, CA, USA., Hou V; Moderna, Mystic, CT, USA., Irwin C; Health Canada, Ottawa, ON, Canada., Jani D; Takeda, San Diego, CA, USA., Joseph J; Health Canada, Ottawa, ON, Canada., Kalina W; Pfizer, Pearl River, NY, USA., Kar S; WRIB, Toronto, ON, Canada., Kavita U; Spark, Philadelphia, Pa, USA., Lu Y; Sangamo, South San Francisco, CA, USA., Marshall JC; Moderna, Mystic, CT, USA., Mayer C; Austria AGES, Vienna, Austria., Mora J; Bristol Myers Squibb, Lawrenceville, NJ, USA., Nolan K; Merck, West Point, PA, USA., Peng K; Genentech, South San Francisco, CA, USA., Riccitelli N; Navigate, a Novartis Subsidiary, San Diego, CA, USA., Scully I; Pfizer, Pearl River, NY, USA., Seitzer J; Intellia, Cambridge, MA, USA., Stern M; Bristol Myers Squibb, Lawrenceville, NJ, USA., Wadhwa M; UK MHRA, London, UK., Xu Y; Intellia, Cambridge, MA, USA., Verthelyi D; US FDA, Silver Spring, MD, USA., Sumner G; Regeneron, Tarrytown, NY, USA., Clements-Egan A; Larimar, Bala Cynwyd, PA, USA., Chen C; AstraZeneca, South San Francisco, CA, USA., Gorovits B; Regeneron, Tarrytown, NY, USA., Torri A; Regeneron, Tarrytown, NY, USA., Baltrukonis D; Pfizer, Groton, CT, USA., Gunn G; GlaxoSmithKline, Collegeville, PA, USA., Ishii-Watabe A; Japan MHLW, Tokyo, Japan., Kramer D; Sanofi, Frankfurt, Germany., Kubiak RJ; AstraZeneca, Gaithersburg, MD, USA., Mullins G; Eli Lilly and Company, Indianapolis, IN, USA., Pan L; Takeda, Cambridge, MA, USA., Partridge MA; Regeneron, Tarrytown, NY, USA., Poetzl J; Sandoz, Oberhaching, Germany., Rasamoelisolo M; Teva, West Chester, PA, USA., Sirtori FR; EMD Serono, Ivrea, TO, Italy., Richards S; Sanofi, Cambridge, MA, USA., Saad OM; Genentech, South San Francisco, CA, USA., Shao W; AstraZeneca, Gaithersburg, MD, USA., Song Y; Genentech, South San Francisco, CA, USA., Song S; Takeda, Cambridge, MA, USA., Staack RF; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany., Wu B; Johnson & Johnson Innovative Medicine, Spring House, PA, USA., Manangeeswaran M; US FDA, Silver Spring, MD, USA., Thacker S; US FDA, Silver Spring, MD, USA.
Source: Bioanalysis [Bioanalysis] 2025 Feb; Vol. 17 (3), pp. 105-149. Date of Electronic Publication: 2025 Jan 25.
Publication Type: Journal Article; Consensus Statement
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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