Validation of the Recombinant Coagulation Factor IX Purification Process for the Removal of Host Cell DNA

ACS Symposium Series

Volumn 698, Issue , 1998, Pages 55-68

  Leonard, M W ^a   Sefton, L ^a   Costigan, R ^a   Shi, L ^a   Hubbard, B ^a   Bonam, D ^a   Kelley, B D ^a   Foster, B ^a   Charlebois, T ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0346544532     PISSN: 00976156     EISSN: None     Source Type: Book Series    
DOI: 10.1021/bk-1998-0698.ch005     Document Type: Article

References (10)

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5. Robertson J.S. and Heath A.B. Biologicals 1995, 23: 199-205
6. Riggin A, Davis G.C. and Copmann T.L. Biopharm 1996, 9: 36-41
7. Characterization of Biotechnology Pharmaceutical Products workshop, Washington D.C., USA. 1995
8. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA. 1997
9. CPMP Positions Statement on DNA and Host Cell Proteins Impurities, Routine Testing Versus Validation Studies. The European Agency for the Evaluation of Medicinal Products. Human Medicines Evaluation Unit. London, June 1997.
10. Haaland P.D. Experimental Design in Biotechnology. Marcel Dekker, New York, 1989.