• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Scientific Publications by FDA Staff

  • Print
  • Share
  • E-mail

Search Publications



Starting Date

Ending Date

Order by

Entry Details

PDA J Pharm Sci Technol 2014 Nov-Dec;68(6):661-6

New technologies and challenges of novel virus detection.

Khan AS, Ma H, Taliaferro LP, Galvin TA, Shaheduzzaman S


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.

Category: Journal Article
PubMed ID: #25475641 DOI: 10.5731/pdajpst.2014.01029
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2014-11-04 Entry Last Modified: 2018-01-28