원문정보
초록
영어
Validation of viral safety is essential in ensuring the safety of mammalian cell culture-derived biopharmaceuticals, because contaminations of genetically engineered Chinese hamster ovary(CHO) cells and baby hamster kidney(BHK) cells for the manufacture of biopharmaceuticals by numerous adventitious viruses have been reported(1). Mammalian cells are highly susceptible to minute virus of mice(MVM), bovine herpesvirus(BHV), and bovine parvovirus(BPV). The major source of viral contamination is fetal bovine serum(FBS) used for cell culture. Therefore viral detection in the mammalian cells and FBS as well as final products is necessary to ensure the safety of biopharmaceuticals against viruses. In the previous study, we developed and validated a multiplex PCR assay to detect MVM, BHV, and BPV(2). In this study, we have developed standards for quantification by cloning each PCR product using the TA cloning vector. The established multiplex PCR assay was successfully applied to the validation CHO cells artificially infected with each virus. (This research was financially supported by the Ministry of Education, Science Technology (MEST) and Korea Industrial Technology Foundation (KOTEF) through the
Human Resource Training Project for Regional Innovation)