원문정보
초록
영어
Virus removal and/or inactivation is a major concern during the manufacture of biologics such as mammalian cell culture-derived biopharmaceuticals, tissue-engineered products, and cell therapy, because numerous adventitious viruses have been contaminated during the manufacture of the products(1). Mammalian cells are highly susceptible to minute virus of mice(MVM) and Reovirus type 3(Reo), and there are several reports of such viruses contamination during the manufacture of biopharmaceuticals. MVM and Reo are non-enveloped viruses and have been known to be very resistant to viral inactivation processes(2). Therefore it is essential for biologics processes to implement such viral inactivation steps. The purpose of the present study was to compare the resistance of MVM and Reo to various viral inactivation processes and then to provide the conceptual design of viral inactivation processes to improve viral safety of biologics. The efficacy of viral inactivation by NaOH treatment (0.1 M and 0.5 M), low pH treatment(pH 3.8), heat treatment at 80 and 90℃, 70% ethanol treatment, ethylene oxide sterilization, and gamma irradiation process will be presented. (This research was financially supported by MEST and KOTEF through the Human Resource Training Project for Regional Innovation, and Small and Medium Business Administration (SMBA) and Daejeon City through Regional Consortium Center)