Research ArticleConference Proceeding - Article
Viral Clearance Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes
Hannelore Willkommen
PDA Journal of Pharmaceutical Science and Technology January 2014, 68 (1) 66-82; DOI: https://doi.org/10.5731/pdajpst.2014.00967
Hannelore Willkommen
Regulatory Affairs & Biological Safety Consulting, Langen, Germany

References
- 1.↵
- 2.↵
PDA Technical Report 47. Preparation of Virus Spikes Used for Virus Clearance Studies. Parenteral Drug Association, Bethesda, MD, 2010.
- 3.↵
- Miesegaes G.,
- Lute S.,
- Dement-Brown J.,
- Kaushal S.,
- Strauss D.,
- Chen D.,
- Brorson K.
- 4.↵
ASTM. E2888–12: Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. ASTM International: West Conshohocken, PA, 2012.
- 5.↵
- 6.↵
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 1
January/February 2014
Viral Clearance Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes
Hannelore Willkommen
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 66-82; DOI: 10.5731/pdajpst.2014.00967
Jump to section
- Article
- Viral Clearance Integration, Current Trends
- Platform Data and Bracketing: Using CPP Analytical Tools to Determine the Impact to Total Viral Clearance (P. Alfonso and H. Shen, Janssen)
- Bracketing Studies for Low pH and Triton X-100 Treatment and Viral Filtration (Glen Bolton, Pfizer)
- Platform Data Considering Different Antibody Products (David Farb; MacroGenics, Inc.)
- Platform Processes: Standardization of Low pH Treatment for Inactivation of Retrovirus (J. Ucran and R. Steininger, Acceleron Pharma)
- RVLP Removal by mAb Purification Process (Min Zhang; Genentech, a Member of the Roche Group)
- Spike Preparation Quality Attributes: Critical Virus Stock Quality Attributes and Production Parameters (Houman Dehghani, Amgen)
- Spike Preparation Quality Attributes: Impact of Virus Spike Preparations on Viral Clearance (George Miesegaes, CDER/FDA)
- References
- Figures & Data
- References
- Info & Metrics
Related Articles
- No related articles found.
Cited By...
- No citing articles found.