Ebola virus-induced eye sequelae: a murine model for evaluating glycoprotein-targeting therapeutics.

Autor: Lee HN; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Xu B; Laboratory of Immunology, National Eye Institute, NIH, Bethesda, MD, 20892, USA., Lewkowicz AP; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Engel K; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Kelley-Baker L; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., McWilliams IL; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Ireland DDC; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Kielczewski JL; Biological Imaging Core, National Eye Institute, NIH, Bethesda, MD, 20892, USA., Li J; Biological Imaging Core, National Eye Institute, NIH, Bethesda, MD, 20892, USA., Fariss RN; Biological Imaging Core, National Eye Institute, NIH, Bethesda, MD, 20892, USA., Campos MM; Biological Imaging Core, National Eye Institute, NIH, Bethesda, MD, 20892, USA., Baum A; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 10591, USA., Kyratsous C; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 10591, USA., Pascal K; Regeneron Pharmaceuticals, Inc., Tarrytown, NY, 10591, USA., Chan CC; Laboratory of Immunology, National Eye Institute, NIH, Bethesda, MD, 20892, USA., Caspi RR; Laboratory of Immunology, National Eye Institute, NIH, Bethesda, MD, 20892, USA., Manangeeswaran M; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Verthelyi D; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA. Electronic address: daniela.verthelyi@fda.hhs.gov.

Publikováno v: EBioMedicine [EBioMedicine] 2024 Jun; Vol. 104, pp. 105170. Date of Electronic Publication: 2024 Jun 01.

2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs ( Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).

Autor: Szapacs M; Abbvie, Philadelphia, PA, USA., Jian W; Janssen, Spring House, PA, USA., Spellman D; Merck, West Point, PA, USA., Cunliffe J; Novartis, Cambridge, MA, USA., Verburg E; Lilly, Indianapolis, IN, USA., Kaur S; Genentech, South San Francisco, CA, USA., Kellie J; GlaxoSmithKline, Collegeville, PA, USA., Li W; Novartis, East Hanover, NJ, USA., Mehl J; GlaxoSmithKline, Collegeville, PA, USA., Qian M; Takeda, Cambridge, MA, USA., Qiu X; WRIB, Montreal, QC, Canada., Sirtori FR; EMD Serono, Ivrea, TO, Italy., Rosenbaum AI; AstraZeneca, South San Francisco, CA, USA., Sikorski T; GlaxoSmithKline, Collegeville, PA, USA., Surapaneni S; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Wang J; Crinetics, San Diego, CA, USA., Wilson A; AstraZeneca, Cambridge, UK., Zhang J; US FDA, Silver Spring, MD, USA., Xue Y; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Post N; Ionis, Carlsbad, CA, USA., Huang Y; AstraZeneca, South San Francisco, CA, USA., Goykhman D; Merck, West Point, PA, USA., Yuan L; Biogen, Cambridge, MA, USA., Fang K; GlaxoSmithKline, Collegeville, PA, USA., Casavant E; Genentech, South San Francisco, CA, USA., Chen L; Boehringer Ingelheim, Ridgefield, CT, USA., Fu Y; Novartis, East Hanover, NJ, USA., Huang M; Regeneron, Tarrytown, NY, USA., Ji A; Chiesi, Boston, MA, USA., Johnson J; Pfizer, Andover, MA, USA., Lassman M; Merck, West Point, PA, USA., Li J; Alnylam, Cambridge, MA, USA., Saad O; Genentech, South San Francisco, CA, USA., Sarvaiya H; Abbvie, San Mateo, CA, USA., Tao L; Sanofi, Framingham, MA, USA., Wang Y; WRIB, Montreal, QC, Canada., Zheng N; Bristol-Myers Squibb, Lawrenceville, NJ, USA., Dasgupta A; US FDA, Silver Spring, MD, USA., Abhari MR; US FDA, Silver Spring, MD, USA., Ishii-Watabe A; Japan MHLW, Tokyo, Japan., Saito Y; Japan MHLW, Tokyo, Japan., Mendes Fernandes DN; Brazil ANVISA, Brasilia, Brazil., Bower J; Precision for Medicine, Chantilly, VA, USA., Burns C; UK MHRA, London, UK., Carleton K; Janssen, Spring House, PA, USA., Cho SJ; US FDA, Silver Spring, MD, USA., Du X; US FDA, Silver Spring, MD, USA., Fjording M; EWG ICH M10, Copenhagen, Denmark., Garofolo F; BRI Frontage, Vancouver, BC, Canada., Kar S; WRIB, Montreal, QC, Canada., Kavetska O; Pfizer, Groton, CT, USA., Kossary E; WHO, Geneva, Switzerland., Lu Y; US FDA, Silver Spring, MD, USA., Mayer A; GlaxoSmithKline, Collegeville, PA, USA., Palackal N; Regeneron, Tarrytown, NY, USA., Salha D; Altasciences, Laval, QC, Canada., Thomas E; Labcorp, Indianapolis, IN, USA., Verhaeghe T; Janssen, Beerse, Belgium., Vinter S; UK MHRA, London, UK., Wan K; Pfizer, San Diego, CA, USA., Wang YM; US FDA, Silver Spring, MD, USA., Williams K; Genentech, South San Francisco, CA, USA., Woolf E; Merck, West Point, PA, USA., Yang L; US FDA, Silver Spring, MD, USA., Yang E; GlaxoSmithKline, Collegeville, PA, USA., Bandukwala A; US FDA, Silver Spring, MD, USA., Hopper S; UK MHRA, London, UK., Maher K; US FDA, Silver Spring, MD, USA., Xu J; US FDA, Jefferson, AR, USA., Brodsky E; US FDA, Silver Spring, MD, USA., Cludts I; UK MHRA, London, UK., Irwin C; Health Canada, Ottawa, ON, Canada., Joseph J; Health Canada, Ottawa, ON, Canada., Kirshner S; US FDA, Silver Spring, MD, USA., Manangeeswaran M; US FDA, Silver Spring, MD, USA., Maxfield K; US FDA, Silver Spring, MD, USA., Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA., Solstad T; Norway NoMA, Oslo, Norway., Thacker S; US FDA, Silver Spring, MD, USA., Tounekti O; Health Canada, Ottawa, ON, Canada., Verthelyi D; US FDA, Silver Spring, MD, USA., Wadhwa M; UK MHRA, London, UK., Wagner L; US FDA, Silver Spring, MD, USA., Yamamoto T; Japan MHLW, Tokyo, Japan., Zhang L; Health Canada, Ottawa, ON, Canada., Zhou L; US FDA, Silver Spring, MD, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2023 Aug; Vol. 15 (16), pp. 955-1016. Date of Electronic Publication: 2023 Aug 31.

2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays ( Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).

Autor: Pan L; Takeda, Cambridge, MA, USA., Mora J; Bristol Myers Squibb, Lawrenceville, NJ, USA., Walravens K; GlaxoSmithKline, Rixensart, Belgium., Wagner L; US FDA, Silver Spring, MD, USA., Hopper S; UK MHRA, London, UK., Loo L; Vertex, Boston, MA, USA., Bettoun D; Larimar, Bala-Cynwyd, PA, USA., Bond S; Alnylam, Cambridge, MA, USA., Dessy F; GlaxoSmithKline, Rixensart, Belgium., Downing S; Takeda, Cambridge, MA, USA., Garofolo F; BRI Frontage, Vancouver, BC, Canada., Gupta S; BioMarin, Novato, CA, USA., Henderson N; AstraZeneca, Gothenburg, Sweden., Irwin C; Health Canada, Ottawa, ON, Canada., Ishii-Watabe A; Japan MHLW, Tokyo, Japan., Kar S; WRIB, Montreal, QC, Canada., Jawa V; Bristol Myers Squibb, Lawrenceville, NJ, USA., Joseph J; Health Canada, Ottawa, ON, Canada., Malvaux L; GlaxoSmithKline, Rixensart, Belgium., Marshall JC; Moderna, Mystic, CT, USA., McDevitt J; Bristol Myers Squibb, Lawrenceville, NJ, USA., Mohapatra S; Stoke, Cambridge, MA, USA., Seitzer J; Intellia, Cambridge, MA, USA., Smith J; Pfizer, Groton, CT, USA., Solstad T; Norway NoMA, Oslo, Norway., Sugimoto H; Takeda, Cambridge, MA, USA., Tounekti O; Health Canada, Ottawa, ON, Canada., Wu B; Janssen R&D, Spring House, PA, USA., Wu Y; AstraZeneca, Gaithersburg, MD, USA., Xu Y; Intellia, Cambridge, MA, USA., Xu J; US FDA, Jefferson, AR, USA., Yamamoto T; Japan MHLW, Tokyo, Japan., Yang L; REGENXBIO, Rockville, MD, USA., Torri A; Regeneron, Tarrytown, NY, USA., Kirshner S; US FDA, Silver Spring, MD, USA., Maxfield K; US FDA, Silver Spring, MD, USA., Vasconcelos JP; US FDA, Silver Spring, MD, USA., Abhari MR; US FDA, Silver Spring, MD, USA., Verthelyi D; US FDA, Silver Spring, MD, USA., Brodsky E; US FDA, Silver Spring, MD, USA., Carrasco-Triguero M; Sangamo, Brisbane, CA, USA., Kamerud J; Pfizer, Groton, CT, USA., Andisik M; Regeneron, Tarrytown, NY, USA., Baltrukonis D; Pfizer, Groton, CT, USA., Bivi N; Lilly, Indianapolis, IN, USA., Cludts I; UK MHRA, London, UK., Coble K; Boehringer Ingelheim, Danbury, CT, USA., Gorovits B; Sana Bio, Cambridge, MA, USA., Gunn GR; GSK, Collegeville, PA, USA., Gupta S; AbbVie, Irvine, CA, USA., Millner AH; Novo Nordisk, Maaloev, Denmark., Joyce A; Pfizer, Groton, CT, USA., Kubiak RJ; AstraZeneca, Gaithersburg, MD, USA., Kumar S; EMD Serono, Boston, MA, USA., Liao K; Merck, West Point, PA, USA., Manangeeswaran M; US FDA, Silver Spring, MD, USA., Partridge M; Regeneron, Tarrytown, NY, USA., Pine S; Sanofi, Ghent, Belgium., Poetzl J; Sandoz, Oberhaching, Germany., Rajadhyaksha M; Alexion, New Haven, CT, USA., Rasamoelisolo M; Teva, West Chester, PA, USA., Richards S; Sanofi, Framingham, MA, USA., Song Y; Genentech, South San Francisco, CA, USA., Swanson S; Genentech, South San Francisco, CA, USA., Thacker S; US FDA, Silver Spring, MD, USA., Wadhwa M; UK MHRA, London, UK., Wolf A; Amgen, Munich, Germany., Zhang L; Health Canada, Ottawa, ON, Canada., Zhou L; US FDA, Silver Spring, MD, USA.

Publikováno v: Bioanalysis [Bioanalysis] 2023 Jul; Vol. 15 (14), pp. 773-814. Date of Electronic Publication: 2023 Aug 01.

BSL2-compliant lethal mouse model of SARS-CoV-2 and variants of concern to evaluate therapeutics targeting the Spike protein.

Autor: Manangeeswaran M; Laboratory of Immunology, Center of Excellence in Infectious Disease and Inflammation, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., Ireland DDC; Laboratory of Immunology, Center of Excellence in Infectious Disease and Inflammation, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., Thacker SG; Laboratory of Immunology, Center of Excellence in Infectious Disease and Inflammation, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., Lee HN; Laboratory of Immunology, Center of Excellence in Infectious Disease and Inflammation, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., Kelley-Baker L; Laboratory of Immunology, Center of Excellence in Infectious Disease and Inflammation, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., Lewkowicz AP; Laboratory of Immunology, Center of Excellence in Infectious Disease and Inflammation, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., Rothlauf PW; Department of Molecular Microbiology, Washington University School of Medicine, St. Louis, MO, United States.; Program in Virology, Harvard Medical School, Boston, MA, United States., Cornejo Pontelli M; Department of Molecular Microbiology, Washington University School of Medicine, St. Louis, MO, United States., Bloyet LM; Department of Molecular Microbiology, Washington University School of Medicine, St. Louis, MO, United States., Eckhaus MA; Division of Veterinary Resources, Office of Research Services, National Institutes of Health, Bethesda, MD, United States., Mendoza MI; Laboratory of Immunology, Center of Excellence in Infectious Disease and Inflammation, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., Whelan S; Department of Molecular Microbiology, Washington University School of Medicine, St. Louis, MO, United States., Verthelyi D; Laboratory of Immunology, Center of Excellence in Infectious Disease and Inflammation, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.

Publikováno v: Frontiers in immunology [Front Immunol] 2022 Jul 28; Vol. 13, pp. 919815. Date of Electronic Publication: 2022 Jul 28 (Print Publication: 2022).

Characterization of the therapeutic effect of antibodies targeting the Ebola glycoprotein using a novel BSL2-compliant rVSVΔG-EBOV-GP infection model.

Autor: Lee HN; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., McWilliams IL; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Lewkowicz AP; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Engel K; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Ireland DDC; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Kelley-Baker L; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Thacker S; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Piccardo P; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Manangeeswaran M; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Verthelyi D; Division of Biotechnology Review and Research-III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Publikováno v: Emerging microbes & infections [Emerg Microbes Infect] 2021 Dec; Vol. 10 (1), pp. 2076-2089.