PT - JOURNAL ARTICLE AU - Arifa S. Khan AU - Hailun Ma AU - Lanyn P. Taliaferro AU - Teresa A. Galvin AU - Syed Shaheduzzaman TI - New Technologies and Challenges of Novel Virus Detection AID - 10.5731/pdajpst.2014.01029 DP - 2014 Nov 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 661--666 VI - 68 IP - 6 4099 - http://journal.pda.org/content/68/6/661.short 4100 - http://journal.pda.org/content/68/6/661.full SO - PDA J Pharm Sci Technol2014 Nov 01; 68 AB - 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.