Robustness Testing of a Chromatographic Purification Step Used in Recombinant Factor IX Manufacture

ACS Symposium Series

Volumn 698, Issue , 1998, Pages 93-113

  Kelley, Brian D ^a   Shi, Lei ^a,b   Bonam, Duane ^a   Hubbard, Brian ^a  

^a PFIZER INC   (United States)

^b AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0347174766     PISSN: 00976156     EISSN: None     Source Type: Book Series    
DOI: 10.1021/bk-1998-0698.ch008     Document Type: Article

References (23)

1. Food and Drug Administration. Guidelines on General Principles of Process Validation, 1987.
2. Food and Drug Administration. Text on Analytical Validation (ICH Guidelines on Validation of Analytical Procedures: Definition and Terminology), 1995.
3. Box, G.E.P.; Hunter, W.G.; Hunter, J.S. Statistics for Experimenters; J. Wiley: New York, NY, 1978.
4. Daniel, C. Applications of Statistics to Industrial Experimentation; J. Wiley: New York, NY, 1976.
5. Haaland, P.D.; Experimental Design in Biotechnology; Marcel Dekker: New York, NY, 1989.
6. Mason, R.L.; Gunst, R.F.; Hess, J.L. Statistical Design and Analysis of Experiments; J. Wiley: New York, NY, 1989.
7. Montgomery, D.C. Design and Analysis of Experiments; J. Wiley: New York, NY, 1991.
8. Cruz, P.M.; Christen, P.; Farres, A. J. Ferm. Bioeng. 1993, 76, pp. 94-97.
9. Emborg, C.; Jepsen, P.K.; Biedermann, K. Biotechnol. Bioeng. 1989, 33, pp. 1393-1399.
10. Greasham, R.; Inamine, E. In Manual of Industrial Microbiology and Biotechnology; Demain, A.L.; Solomon, N.A., Ed.; American Society of Microbiology: Washington, D.C., 1986.
11. Greasham, R. In Biotechnology; Stephanopolous, G. Ed.; VCH Publishers: Weinheim, Vol 3, Bioprocessing.
12. Serralheiro, M.L.M; Cabrai, J.M.S. Biotechnol. Bioeng. 1994, 43, pp. 1031-1042.
13. Vindevogel, J.; Sandra, P. Anal. Chem., 1991, 63, pp. 1530-1536.
14. Weatherell, C.J.; Lai, E.P.C. J. Chrom., 1994, 669, pp. 31-44.
15. Berggrund, A.; Drevin, I.; Knuuttila, K.-G.; Wardhammar, J.; Johansson, B.-L. Proc. Biochem., 1994, 29, pp. 455-463.
16. Gaertner, J.G.; Dhurjati, P. Biotechnol. Prog., 9 pp. 298-308.
17. Gaertner, J.G.; Dhurjati, P. Biotechnol. Prog., 9 pp. 309-316.
18. Kelley, B.D.; Jennings, P; Wright R.; Briasco, C. BioPharm, 1997, 10 (10). pp. 36-47.
19. Jobson, J.D.; Applied Multivariate Data Analyis; Springer-Verlag: New York, NY, 1992.
20. Barry, A.R.; Chojnacki, R. BioPharm 1994, 7, pp. 43-47.
21. Kuwahara, S.S.; Chuan, J.H. In Separations Technology: Pharmaceutical and Biotechnology Applications, Olson, W.P., Ed.; Interpharm Press: Buffalo Grove, IL, 1996; pp. 427-451.
22. Sofer, G.; Hagel, L. Handbook of Process Chromatography: A Guide to Optimization, Scale-up, and Validation; Academic Press: San Diego, CA, 1997.
23. Zar, J. H. Biostatistical Analysis; Prentice-Hall: Upper Saddle River, NJ, 1996.