Research ArticleResearch
Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration
John Mattila, Sherrie Curtis, Yenny Webb-Vargas, Eileen Wilson, Olga Galperina, David Roush, Scott Tobler, Bradford Stanley, Mike Clark, Justin Weaver, Jeremy Pike, Deqiang Yu, Xinfang Li, Andreas Flicker, Johanna Kindermann, Norbert Schuelke, Richard Whitcombe and Louise Bennett
PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 470-486; DOI: https://doi.org/10.5731/pdajpst.2018.009605
John Mattila
1Regeneron Pharmaceuticals Inc., Tarrytown, NY;
Sherrie Curtis
2Genentech, Inc., South San Francisco, CA;
Yenny Webb-Vargas
2Genentech, Inc., South San Francisco, CA;
Eileen Wilson
3GlaxoSmithKline plc, King of Prussia, PA;
Olga Galperina
4GlaxoSmithKline plc, Rockville, MD;
David Roush
5Merck & Co., Inc., Kenilworth, NJ, USA;
Scott Tobler
5Merck & Co., Inc., Kenilworth, NJ, USA;
Bradford Stanley
6Biogen, Research Triangle Park, NC;
Mike Clark
7AbbVie Bioresearch Center, Worcester, MA;
Justin Weaver
8Alexion Pharmaceuticals, Inc. Boston, MA;
Jeremy Pike
8Alexion Pharmaceuticals, Inc. Boston, MA;
Deqiang Yu
9Bristol-Myers Squibb, Devens MA;
Xinfang Li
10ImmunoGen, Inc. Waltham, MA;
Andreas Flicker
11Shire plc, Lexington, MA;
Johanna Kindermann
11Shire plc, Lexington, MA;
Norbert Schuelke
12Takeda Pharmaceuticals International Co., Cambridge, MA;
Richard Whitcombe
13UCB, Brussels, Belgium; and
Louise Bennett
14BioPhorum Operations Group, London, U.K.

References
- 1.↵
- 2.↵
- Garnick R. L.
- 3.↵
- Nims R. W.
- 4.↵European Medicines Agency, Guideline on Virus Safety Evaluation of Biotechnology Investigational Medicinal Products. EMA: London, 2008.
- 5.↵European Agency for the Evaluation of Medicinal Products, Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses; CPMP/BWP/268/95; Committee for Proprietary Medicinal Products; EMA: London, 1996.
- 6.↵U.S. Food and Drug Administration, Points to Consider in the Manufacture and Testing of Monoclonal Antibodies for Human Use; Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services: Rockville, MD, 1997.
- 7.↵International Conference for Harmonisation, Quality Guideline Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. ICH: Geneva, Switzerland, 1998.
- 8.↵
- Blümel J.,
- Brorson K.
- 9.↵
- 10.↵European Medicines Agency, Meeting Report: Joint BWP/QWP Workshop with Stakeholders in Relation to Prior Knowledge and Its Use in Regulatory Applications; Doc. Ref. EMA/CHMP/BWP/187162/2018; EMA: London, 2018.
- 11.↵
- 12.↵
- 13.↵
- 14.↵
- Roush D.
- 15.↵
- 16.↵
- 17.↵
- Zhang M.,
- Miesegaes G. R.,
- Lee M.,
- Coleman D.,
- Yang B.,
- Trexler-Schmidt M.,
- Norling L.,
- Lester P.,
- Brorson K. A.,
- Chen Q.
- 18.↵
- Bach J.,
- Connell-Crowley L.
- 19.↵
- Strauss D. M.,
- Lute S.,
- Tebaykina Z.,
- Frey D. D.,
- Ho C.,
- Blank G. S.,
- Brorson K.,
- Chen Q.,
- Yang B.
- 20.↵
- 21.↵U.S. Pharmacopeial Convention, General Chapter <1050.1> Viral Clearance Procedures. In USP 39–NF 34, USP: Rockville, MD, 2016; pp 7745–7755.
- 22.↵Parenteral Drug Association Inc. Preparation of Virus Spikes Used for Viral Clearance Studies; Technical Report No. 47; PDA: Bethesda, MD, 2010.
- 23.
- Nicola A. V.,
- Peng C.,
- Lou H.,
- Cohen G. H.,
- Eisenberg R. J.
- 24.
- 25.
- Venkatakrishnan B.,
- Yarbrough J.,
- Domsic J.,
- Bennett A.,
- Bothner B.,
- Kozyreva O. G.,
- Samulski R. J.,
- Muzyczka N.,
- McKenna R.,
- Agbandje-McKenna M.
- 26.
- Seabrook E. J.,
- Turton T. N.,
- Conlan B.
- 27.
- 28.
- Walsh A. A.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 5
September/October 2019
Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration
John Mattila, Sherrie Curtis, Yenny Webb-Vargas, Eileen Wilson, Olga Galperina, David Roush, Scott Tobler, Bradford Stanley, Mike Clark, Justin Weaver, Jeremy Pike, Deqiang Yu, Xinfang Li, Andreas Flicker, Johanna Kindermann, Norbert Schuelke, Richard Whitcombe, Louise Bennett
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 470-486; DOI: 10.5731/pdajpst.2018.009605
Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration
John Mattila, Sherrie Curtis, Yenny Webb-Vargas, Eileen Wilson, Olga Galperina, David Roush, Scott Tobler, Bradford Stanley, Mike Clark, Justin Weaver, Jeremy Pike, Deqiang Yu, Xinfang Li, Andreas Flicker, Johanna Kindermann, Norbert Schuelke, Richard Whitcombe, Louise Bennett
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 470-486; DOI: 10.5731/pdajpst.2018.009605
Jump to section
Related Articles
- No related articles found.