Report of the Assay Guidance Workshop on 3-Dimensional Tissue Models for Antiviral Drug Development.

Autor: Jordan R; Bill and Melinda Gates Foundation, Seattle, Washington, USA., Ford-Scheimer SL; National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, USA., Alarcon RM; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Atala A; Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA., Borenstein JT; Draper Laboratory, Cambridge, Massachusetts, USA., Brimacombe KR; National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, USA., Cherry S; Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Clevers H; Hubrecht Institute, Utrecht, The Netherlands., Davis MI; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Funnell SGP; UK Health Security Agency, Salisbury, United Kingdom.; Quadram Institute Bioscience, Norwich, United Kingdom., Gehrke L; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.; Harvard Medical School, Boston, Massachusetts, USA., Griffith LG; Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.; Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA., Grossman AC; National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, USA., Hartung T; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.; Department of Molecular Microbiology and Immunology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA., Ingber DE; Harvard Medical School, Boston, Massachusetts, USA.; Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, Massachusetts, USA.; Harvard School of Engineering and Applied Sciences, Cambridge, Massachusetts, USA.; Boston Children's Hospital, Boston, Massachusetts, USA., Kleinstreuer NC; National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle, North Carolina, USA., Kuo CJ; Department of Medicine, Division of Hematology, Stanford University School of Medicine, Stanford, California, USA., Lee EM; National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, USA., Mummery CL; Leiden University Medical Center, Leiden, The Netherlands., Pickett TE; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Ramani S; Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA., Rosado-Olivieri EA; RumiViro, RUMI Scientific, Inc, New York, New York, USA., Struble EB; US Food and Drug Administration, Silver Spring, Maryland, USA., Wan Z; Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA., Williams MS; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Hall MD; National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, USA., Ferrer M; National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, USA., Markossian S; National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, USA.

Publikováno v: The Journal of infectious diseases [J Infect Dis] 2023 Oct 03; Vol. 228 (Suppl 5), pp. S337-S354.

Uses and Challenges of Antiviral Polyclonal and Monoclonal Antibody Therapies.

Autor: Struble EB; Division of Plasma Derivatives, Office of Plasma Protein Therapeutics CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD 20993, USA., Rawson JMO; Division of Antivirals, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD 20993, USA., Stantchev T; Division of Biotechnology Review and Research 1, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD 20993, USA., Scott D; Division of Plasma Derivatives, Office of Plasma Protein Therapeutics CMC, Office of Therapeutic Products, Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD 20993, USA., Shapiro MA; Division of Biotechnology Review and Research 1, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD 20993, USA.

Publikováno v: Pharmaceutics [Pharmaceutics] 2023 May 19; Vol. 15 (5). Date of Electronic Publication: 2023 May 19.

Zika Virus Infection and Antibody Neutralization in FcRn Expressing Placenta and Engineered Cell Lines.

Autor: Xu Y; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., He Y; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Momben-Abolfath S; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Vertrees D; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Li X; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Norton MG; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA., Struble EB; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA.

Publikováno v: Vaccines [Vaccines (Basel)] 2022 Nov 30; Vol. 10 (12). Date of Electronic Publication: 2022 Nov 30.

Entry and Disposition of Zika Virus Immune Complexes in a Tissue Culture Model of the Maternal-Fetal Interface.

Autor: Xu Y; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993-0002, USA., He Y; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993-0002, USA., Momben-Abolfath S; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993-0002, USA., Eller N; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993-0002, USA., Norton M; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993-0002, USA., Zhang P; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993-0002, USA., Scott D; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993-0002, USA., Struble EB; Laboratory of Plasma Derivatives, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993-0002, USA.

Publikováno v: Vaccines [Vaccines (Basel)] 2021 Feb 11; Vol. 9 (2). Date of Electronic Publication: 2021 Feb 11.

Binding and neutralizing anti-cytomegalovirus activities in immune globulin products.

Autor: Wang X; Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA, United States., Xu Y; Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, CBER, FDA, United States., Scott DE; Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, CBER, FDA, United States., Murata H; Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA, United States., Struble EB; Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, CBER, FDA, United States. Electronic address: evi.struble@fda.hhs.gov.

Publikováno v: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2017 Nov; Vol. 50, pp. 35-41. Date of Electronic Publication: 2017 Oct 10.