References
US Food and Drug Administration. (1993). Points to Consider in the
Characterization of Cell Lines used to produce Biologicals.
Barone, P. W., Wiebe, M. E., Leung, J. C., Hussein, I. T. M., Keumurian,
F. J., Bouressa, J., . . . Springs, S. L. (2020). Viral contamination in
biologic manufacture and implications for emerging therapies. Nat
Biotechnol. doi:10.1038/s41587-020-0507-2
Berting, A., Farcet, M. R., & Kreil, T. R. (2010). Virus susceptibility
of Chinese hamster ovary (CHO) cells and detection of viral
contaminations by adventitious agent testing. Biotechnology and
Bioengineering, 106(4), 598-607.
Burnouf, T., Radosevich, M., Goubran, H. A., & Willkommen, H. (2005).
Place of Nanofiltration for Assuring Viral Safety of Biologicals. Curr
Nanosci, 1, 189-201.
Dichtelmueller, H., Biesert, L., Fabbrizzi, F., Gajardo, R., Groner, A.,
von Hoegen, I., . . . Poelsler, G. (2009). Robustness of
solvent/detergent treatment of plasma derivatives: a data collection
from Plasma Protein Therapeutics Association member companies.
Transfusion, 49, 1931-1943.
Harcourt, J., Tamin, A., Lu, X., Kamili, S., Sakthivel, S. K., Murray,
J., . . . Thornburg, N. J. (2020). Severe Acute Respiratory Syndrome
Coronavirus 2 from Patient with 2019 Novel Coronavirus Disease, United
States. Emerg Infect Dis, 26(6). doi:10.3201/eid2606.200516
Hoffmann, M., Kleine-Weber, H., Schroeder, S., Kruger, N., Herrler, T.,
Erichsen, S., . . . Pohlmann, S. (2020). SARS-CoV-2 Cell Entry Depends
on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease
Inhibitor. Cell. doi:10.1016/j.cell.2020.02.052
ICH Topic Q5A. (1997). Note for Guidance on Quality of Biotechnological
Products: Viral Safety Evaluation of Biotechnology Products Derived from
Cell Lines of Human or Animal Origin. (ICH/295/95).
Kaye, M. (2006). SARS-associated coronavirus replication in cell lines.
Emerg Infect Dis, 12(1), 128-133. doi:10.3201/eid1201.050496
Warner, F. J., Lew, R. A., Smith, A. I., Lambert, D. W., Hooper, N. M.,
& Turner, A. J. (2005). Angiotensin-converting enzyme 2 (ACE2), but not
ACE, is preferentially localized to the apical surface of polarized
kidney cells. J Biol Chem, 280(47), 39353-39362.
doi:10.1074/jbc.M508914200
Zhou, P., Yang, X. L., Wang, X. G., Hu, B., Zhang, L., Zhang, W., . . .
Shi, Z. L. (2020). A pneumonia outbreak associated with a new
coronavirus of probable bat origin. Nature, 579(7798), 270-273.
doi:10.1038/s41586-020-2012-7
Table 1 SARS-CoV-2 titers
(TCID50/mL) in supernatants of Vero and HEK-293
inoculated in duplicate at MOIs of 0.01 and 1, respectively.