Viral safety testing for biopharmaceuticals: Current and future prospects
Author:
YUSA Keisuke1, YUSA Yuzhe1, UCHIDA Kazuhisa1
Affiliation:
1. Graduate School of Science, Technology, and Innovation, Kobe University, 7-1-49 Minamijima Minamimachi, Chuo-ku, Kobe 650-0047, Japan
Publisher
AMED iD3 Catalyst Unit
Reference19 articles.
1. 1. Barone, P. W., Wiebe, M. E., Leung, J. C., Hussein, I. T. M., Keumurian, F. J., Bouressa, J., Brussel, A., Chen, D., Chong, M., Dehghani, H., Gerentes, L., Gilbert, J., Gold, D., Kiss, R., Kreil, T. R., Labatut, R., Li, Y., Müllberg, J., Mallet, L., Menzel, C., Moody, M., Monpoeho, S., Murphy, M., Plavsic, M., Roth, N. J., Roush, D., Ruffing, M., Schicho, R., Snyder, R., Stark, D., Zhang, C., Wolfrum, J., Sinskey, A. J. and Springs, S. L. 2020. Viral contamination in biologic manufacture and implications for emerging therapies. Nat. Biotechnol. 38: 563–572. 2. 2. Bethencourt, V. 2009. Virus stalls Genzyme plant. Nat. Biotechnol. 27: 681. 3. 3. Oehmig, A., Büttner, M., Weiland, F., Werz, W., Bergemann, K. and Pfaff, E. 2003. Identification of a calicivirus isolate of unknown origin. J. Gen. Virol. 84: 2837–2845. 4. 4. International Council on Harmonisation Q5A(R1) 1999. Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. https://database.ich.org/sites/default/files/Q5A%28R1%29%20Guideline_0.pdf [accessed Sepember 23, 1999]. 5. 5. Stocking, C. and Kozak, C. A. 2008. Murine endogenous retroviruses. Cell. Mol. Life Sci. 65: 3383–3398.
|
|