RT Journal Article
SR Electronic
T1 Adventitious Viruses Detected in Biopharmaceutical Bulk Harvest Samples over a 10 Year Period
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 481
OP 485
VO 64
IS 5
A1 Kerr, Andrew
A1 Nims, Raymond
YR 2010
UL http://journal.pda.org/content/64/5/481.abstract
AB While viral safety is a major concern for biologics manufactured using mammalian cells, the numbers of viral contamination events reported in the literature are quite low. During a 10-year period during which biologics derived from a variety of mammalian cell culture processes were evaluated using the in vitro virus screening assay, only reovirus type 2 and Cache Valley virus were detected, and these only in biologics manufactured in Chinese hamster ovary (CHO) cells. From the literature, we know that the murine parvovirus mouse minute virus has also been detected in biologics manufactured using CHO cells. The manifestations of these viral contaminants within the biotech manufacturing processes are discussed, as are the likely sources of the contaminants and some possible approaches for mitigating the risk of future occurrences of these types of contamination.