Article CommentaryCommentary
Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing
Paul W. Barone, Stephen Avgerinos, Rob Ballard, Audrey Brussel, Philip Clark, Chris Dowd, Lionel Gerentes, Ian Hart, Flora J. Keumurian, Johanna Kindermann, James C. Leung, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mullberg, Marie Murphy, Kerstin Nöske, Sandi Parriott, Bonnie Shum, Michael E. Wiebe and Stacy L. Springs
PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 191-203; DOI: https://doi.org/10.5731/pdajpst.2018.008862
Paul W. Barone
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA;
Stephen Avgerinos
2Pfizer, Andover, MA, USA;
Rob Ballard
3Biogen, Durham, NC, USA;
Audrey Brussel
4LFB, France;
Philip Clark
5Amgen, Thousand Oaks, CA, USA;
Chris Dowd
6Genentech, South San Francisco, CA, USA;
Lionel Gerentes
7Sanofi, France;
Ian Hart
8MedImmune, Gaithersburg, MD, USA;
Flora J. Keumurian
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA;
Johanna Kindermann
9Shire, Vienna, Austria;
James C. Leung
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA;
Nguyen Ly
10Merck & Co., Inc., Kenilworth, NJ, USA;
Sheldon Mink
11Regeneron, Rensselaer, NY, USA;
Stefan Minning
12Boehringer Ingelheim, Germany;
Jürgen Mullberg
13Bristol-Myers Squibb, Devens, MA, USA;
Marie Murphy
14Eli Lilly, Dublin, Ireland;
Kerstin Nöske
15CSL Behring, Marburg, Germany; and
Sandi Parriott
16BioMarin, San Rafael, CA, USA.
Bonnie Shum
5Amgen, Thousand Oaks, CA, USA;
Michael E. Wiebe
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA;
Stacy L. Springs
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA;

References
- 1.↵International Organization for Standardization, Q5A: Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. 1999; pp 1–27.
- 2.↵World Health Organization. Good Manufacturing Practices for Biological Products. 2016.
- 3.↵U.S. Food and Drug Administration, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Guidance for Industry, 2016.
- 4.↵Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S), Inspection of Biotechnology Manufactures. (PIC/S), Aide Memoire, 2006.
- 5.↵World Health Organization. Guidelines on Viral Inactivation and Removal Procedures Intended to Assure the Viral Safety of Human Blood Plasma Products, 2004.
- 6.↵World Health Organization. Requirements for the Collection, Processing and Control of Blood, Blood Components and Plasma Derivatives, 1994.
- 7.↵U.S. Food and Drug Administration, SOPP 8401.4: Review Responsibilities for the CMC Section of Biologic License Applications and Supplements, 2005.
- 8.↵U.S. Food and Drug Administration, Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use, 1996.
- 9.↵
- Palberg T.,
- Johnson J.,
- Probst S.,
- Gil P.,
- Rogalewicz J.,
- Kennedy M.,
- Green K.,
- Chalk S.
- 10.↵
- Odum J.
- 11.↵International Society for Pharmaceutical Engineering, Baseline Guide Volume 6: Biopharmaceutical Manufacturing Facilities, 2013.
- 12.↵
- Brown F.,
- Lubiniecki A.
- Ogrady J.,
- Losikoff A.,
- Poiley J.,
- Fickett D.,
- Oliver C.
- 13.↵
- Burnouf-Radosevich M.,
- Appourchaux P.,
- Huart J. J.,
- Burnouf T.
- 14.↵
- Dichtelmuller H. O.,
- Biesert L.,
- Fabbrizzi F.,
- Gajardo R.,
- Groner A.,
- von Hoegen I.,
- Jorguera J. I.,
- Kempf C.,
- Kreil T. R.,
- Pifat D.,
- Osheroff W.,
- Poelsler G.
- 15.↵
- Robertson J. S.
- Dichtelmuller H.
- 16.↵
- Kelley B. D.,
- Jakubik J.,
- Vicik S.
- 17.↵
- Shukla A. A.,
- Hubbard B.,
- Tressel T.,
- Guhan S.,
- Low D.
- 18.↵
- Brorson K.,
- Krejci S.,
- Lee K.,
- Hamilton E.,
- Stein K.,
- Xu Y.
- 19.↵European Medicines Agency. Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses, 1996.
- 20.↵
- Odum J.,
- Witcher M.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 2
March/April 2019
Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing
Paul W. Barone, Stephen Avgerinos, Rob Ballard, Audrey Brussel, Philip Clark, Chris Dowd, Lionel Gerentes, Ian Hart, Flora J. Keumurian, Johanna Kindermann, James C. Leung, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mullberg, Marie Murphy, Kerstin Nöske, Sandi Parriott, Bonnie Shum, Michael E. Wiebe, Stacy L. Springs
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 191-203; DOI: 10.5731/pdajpst.2018.008862
Jump to section
Related Articles
- No related articles found.