Virus Removal and Inactivation: A Decade of Validation Studies: Critical Evaluation of the Data Set

ACS Symposium Series

Volumn 698, Issue , 1998, Pages 114-124

  Walter, Joachim K ^a   Nothelfer, Franz ^a   Werz, William ^a  

^a BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0347804790     PISSN: 00976156     EISSN: None     Source Type: Book Series    
DOI: None     Document Type: Review

References (9)

1. Berthold, W., Walter, J.K., Protein Purification: Aspects of Processes for Pharmaceutical Products, Biologicals, 1994, vol 22, pp. 135-150.
2. Walter, J.K., Werz, W., Berthold, W., in: Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products, eds. Brown, F., Lubiniecki, A.S., Dev Biol Stand, Karger, Basel, 1996, vol 88, pp. 99-108.
3. Berthold, W., Walter, J.K., Werz, W., Experimental approaches to guarantee minimal risk of potential virus in purified monoclonal antibodies, Cytotechnology, 1992, vol 9, pp. 189-201.
4. Walter, J.K., Werz, W., Berthold, W., Virus Removal and Inactivation, BFE, 1992, vol 9, no 9, pp. 560-564.
5. Walter, J.K., Allgaier, H., Validation of Downstream Process, in: Mammalian Cell Biotechnology in Protein Production, eds. Hauser, H., Wagner. R. Walter de Gruyter: Berlin, New York, 1997, pp. 453-482.
6. U.S. Department of Health and Human Services, Center for Biologies Evaluation and Research, Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, FDA, Rockville, MD, USA, 1997.
7. ICH Q5A, Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, 1997.
8. CPMP, Virus Validation Studies: Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses, CPMP/268/95, 1996.
9. Walter, J.K., Winter, H., Striffler, U., Microwave Heat Inactivation of Virus: Resistance of Pharmaceutical Proteins Exposed to High Temperature Short Time Heat Treatment, IBC's Symposium on Viral Clearance, Philadelphia, PA, USA, Oct 27-28, 1997.