RT Journal Article
SR Electronic
T1 New Technologies and Challenges of Novel Virus Detection
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 661
OP 666
DO 10.5731/pdajpst.2014.01029
VO 68
IS 6
A1 Khan, Arifa S.
A1 Ma, Hailun
A1 Taliaferro, Lanyn P.
A1 Galvin, Teresa A.
A1 Shaheduzzaman, Syed
YR 2014
UL http://journal.pda.org/content/68/6/661.abstract
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.