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1

Viral risk mitigation for Mammalian cell culture media.

Weaver B, Rosenthal S. Weaver B, et al. PDA J Pharm Sci Technol. 2010 Sep-Oct;64(5):436-9. PDA J Pharm Sci Technol. 2010. PMID: 21502048

2

Evolution of approaches to viral safety issues for biological products.

Lubiniecki AS. Lubiniecki AS. PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):547-56. doi: 10.5731/pdajpst.2011.00818. PDA J Pharm Sci Technol. 2011. PMID: 22294576

3

Review: High temperature short time treatment of cell culture media and feed solutions to mitigate adventitious viral contamination in the biopharmaceutical industry.

Djemal L, Fournier C, von Hagen J, Kolmar H, Deparis V. Djemal L, et al. Biotechnol Prog. 2021 May;37(3):e3117. doi: 10.1002/btpr.3117. Epub 2021 Jan 9. Biotechnol Prog. 2021. PMID: 33372404 Review.

4

Risk Mitigation in Preventing Adventitious Agent Contamination of Mammalian Cell Cultures.

Shiratori M, Kiss R. Shiratori M, et al. Adv Biochem Eng Biotechnol. 2018;165:75-93. doi: 10.1007/10_2017_38. Adv Biochem Eng Biotechnol. 2018. PMID: 29134459

5

Proceedings of the 2017 Viral Clearance Symposium, Session 1.2: Upstream Mitigation, Part 2-Virus Barrier Filter and HTST.

Chen D, Bolton G. Chen D, et al. PDA J Pharm Sci Technol. 2018 Sep-Oct;72(5):462-469. doi: 10.5731/pdajpst.2018.009100. Epub 2018 Jul 20. PDA J Pharm Sci Technol. 2018. PMID: 30030355

6

Safety assurance for biologics manufactured in mammalian cell cultures: a multitiered strategy.

Chen D. Chen D. Adv Biochem Eng Biotechnol. 2014;139:167-83. doi: 10.1007/10_2013_213. Adv Biochem Eng Biotechnol. 2014. PMID: 23719711

7

Risk mitigation strategies for viral contamination of biotechnology products: consideration of best practices.

Rosenberg AS, Cherney B, Brorson K, Clouse K, Kozlowski S, Hughes P, Friedman R. Rosenberg AS, et al. PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):563-7. doi: 10.5731/pdajpst.2011.00820. PDA J Pharm Sci Technol. 2011. PMID: 22294578

8

Susceptibility of mouse minute virus to inactivation by heat in two cell culture media types.

Schleh M, Romanowski P, Bhebe P, Zhang L, Chinniah S, Lawrence B, Bashiri H, Gaduh A, Rajurs V, Rasmussen B, Chuck A, Dehghani H. Schleh M, et al. Biotechnol Prog. 2009 May-Jun;25(3):854-60. doi: 10.1002/btpr.181. Biotechnol Prog. 2009. PMID: 19405099

9

Adventitious Viruses Detected in Biopharmaceutical Bulk Harvest Samples over a 10 Year Period.

Kerr A, Nims R. Kerr A, et al. PDA J Pharm Sci Technol. 2010 Sep-Oct;64(5):481-5. PDA J Pharm Sci Technol. 2010. PMID: 21502056

10

Practicing safe cell culture: applied process designs for minimizing virus contamination risk.

Kiss RD. Kiss RD. PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):715-29. doi: 10.5731/pdajpst.2011.00852. PDA J Pharm Sci Technol. 2011. PMID: 22294606

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