Evaluating the sensitivity of newborn rats and newborn hamsters to oncogenic DNA.

Autor: Sheng-Fowler L; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Tu W; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Phy K; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Macauley J; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Lanning L; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, 20888, USA., Lewis AM Jr; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Peden K; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA. Electronic address: keith.peden@fda.hhs.gov.

Publikováno v: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2023 Nov; Vol. 84, pp. 101724. Date of Electronic Publication: 2023 Nov 16.

Development of a micro-neutralization assay for ebolaviruses using a replication-competent vesicular stomatitis hybrid virus and a quantitative PCR readout.

Autor: Lee SS; Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Phy K; Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Peden K; Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States. Electronic address: keith.peden@fda.hhs.gov., Sheng-Fowler L; Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.

Publikováno v: Vaccine [Vaccine] 2017 Oct 04; Vol. 35 (41), pp. 5481-5486. Date of Electronic Publication: 2017 Apr 17.

A mouse strain defective in both T cells and NK cells has enhanced sensitivity to tumor induction by plasmid DNA expressing both activated H-Ras and c-Myc.

Autor: Sheng-Fowler L; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America., Tu W; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America., Fu H; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America., Murata H; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America., Lanning L; National Institute of Allergy and Infectious Diseases, Rockville, Maryland, United States of America., Foseh G; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America., Macauley J; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America., Blair D; National Cancer Institute, Rockville, Maryland, United States of America., Hughes SH; Frederick Cancer Research Facility, National Cancer Institute, Frederick, Maryland, United States of America., Coffin JM; Frederick Cancer Research Facility, National Cancer Institute, Frederick, Maryland, United States of America; Tufts University, Boston, Massachusetts, United States of America., Lewis AM Jr; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America., Peden K; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, United States of America.

Publikováno v: PloS one [PLoS One] 2014 Oct 10; Vol. 9 (10), pp. e108926. Date of Electronic Publication: 2014 Oct 10 (Print Publication: 2014).

Thermostable chaperone-based polypeptide biosynthesis: Enfuvirtide model product quality and protocol-related impurities.

Autor: Zenin, Vladimir¹ (AUTHOR) zenanmail@icloud.com, Tsedilin, Andrey¹ (AUTHOR), Yurkova, Maria¹ (AUTHOR), Siniavin, Andrey² (AUTHOR), Fedorov, Alexey¹ (AUTHOR)

Publikováno v: PLoS ONE. 6/8/2023, Vol. 17 Issue 6, p1-14. 14p.

Issues associated with residual cell-substrate DNA in viral vaccines.

Autor: Sheng-Fowler L; Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drugs Administration, Bethesda, MD 20892, USA., Lewis AM Jr, Peden K

Publikováno v: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2009 Jun; Vol. 37 (3), pp. 190-5. Date of Electronic Publication: 2009 Mar 14.