Research ArticleConference Proceedings
Proceedings of the 2019 Viral Clearance Symposium, Session 1: Viral Clearance Strategies and Case Studies
Simon Reitz and Astrid Schwantes
PDA Journal of Pharmaceutical Science and Technology July 2022, 76 (4) 297-305; DOI: https://doi.org/10.5731/pdajpst.2021.012677
Simon Reitz
1Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riss, Germany; and
Astrid Schwantes
2Virology Department, Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany

References
- 1.↵European Medicines Agency, Guideline on Virus Safety Evaluation of Biotechnological Investigation Medicinal Products. EMA: London, 2008.
- 2.↵U.S. Food and Drug Administration, Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services: Rockville, MD, 1997.
- 3.↵
- Sipple P.,
- Nguyen T.,
- Patel K.,
- Jaffe N.,
- Chen Y.,
- Khetan A.
- 4.↵
- Schwantes A.,
- Specht R.,
- Chen Q.
- 5.↵
- Kreil T. R.,
- Roush D.
- 6.↵
- Mattila J.,
- Clark M.,
- Liu S.,
- Pieracci J.,
- Gervais T. R.,
- Wilson E.,
- Galperina O.,
- Li X.,
- Roush D.,
- Zoeller K.,
- Brough H.,
- Simpson-Platre C.
- 7.↵ASTM International. ASTM E2888–12 Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. ASTM: West Conshohocken, PA, 2012.
- 8.↵ASTM International. ASTM E3042 Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment. ASTM: West Conshohocken, PA, 2016.
- 9.↵PDA Virus Filtration Task Force. PDA Technical Report No. 41, Revised 2008: Virus Filtration. PDA J. Pharm. Sci. Technol. 2008, 62 (S-4).
- 10.↵
- 11.↵International Conference for Harmonisation, Q5A(R1) Step 5, Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. ICH: Geneva, 1997.
- 12.↵
- Wulff N. H.,
- Tzatzaris M.,
- Young P. J.
- 13.↵European Medicines Agency, Meeting Report: Joint BWP/QWP Workshop with Stakeholders in Relation to Prior Knowledge and Its Use in Regulatory Applications. EMA: London, 2018.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 4
July/August 2022
Proceedings of the 2019 Viral Clearance Symposium, Session 1: Viral Clearance Strategies and Case Studies
Simon Reitz, Astrid Schwantes
PDA Journal of Pharmaceutical Science and Technology Jul 2022, 76 (4) 297-305; DOI: 10.5731/pdajpst.2021.012677
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.