title: New technologies and challenges of novel virus detection.
abstract: The use of new cell substrates for the development of biologicals, particularly tumorigenic and tumor-derived cell lines, can pose a major regulatory challenge due to safety concerns related to the presence of novel viruses, latent and occult viruses including oncogenic viruses, and endogenous retroviruses, since these may not be detected by the currently recommended conventional assays. This report is a summary of our laboratory's experiences using advanced nucleic acid-based technologies to evaluate a Madin-Darby canine kidney (MDCK) cell line and the insect Sf9 cell line derived from Spodoptera frugiperda, and presents some ongoing efforts to address the challenges of novel virus detection.
authors.affiliation: Division of Viral Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD, USA arifa.khan@fda.hhs.gov.
authors.forename: Arifa S
authors.initials: AS
authors.lastname: Khan
authors.affiliation: Division of Viral Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD, USA.
authors.forename: Hailun
authors.initials: H
authors.lastname: Ma
authors.affiliation: Division of Viral Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD, USA.
authors.forename: Lanyn P
authors.initials: LP
authors.lastname: Taliaferro
authors.affiliation: Division of Viral Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD, USA.
authors.forename: Teresa A
authors.initials: TA
authors.lastname: Galvin
authors.affiliation: Division of Viral Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD, USA.
authors.forename: Syed
authors.initials: S
authors.lastname: Shaheduzzaman
mesh_terms: D000818:Animals; D001688:Biological Products / Q000032:analysis*; D001702:Biopharmaceutics / Q000379:methods*; D018929:Cell Culture Techniques; D019295:Computational Biology; D004279:DNA, Viral / Q000235:genetics; D030541:Databases, Genetic; D004285:Dogs; D004340:Drug Contamination / Q000517:prevention & control*; D059014:High-Throughput Nucleotide Sequencing; D006801:Humans; D061985:Madin Darby Canine Kidney Cells; D020411:Oligonucleotide Array Sequence Analysis; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000235:genetics; D061987:Sf9 Cells; D021241:Spectrometry, Mass, Electrospray Ionization; D014773:Virology / Q000379:methods*; D014780:Viruses / Q000235:genetics*
chemical_list: D001688:Biological Products; D004279:DNA, Viral; D012367:RNA, Viral
keywords: Adventitious agents; Cell substrate; Endogenous retroviruses; Latent viruses; Massively parallel sequencing; Novel viruses; Occult viruses; PLEX-ID; Virus microarrays