CONCLUSIONS
Improvements in feedstream titers translate into the need for improvements in downstream processing productivity. A multiprong
approach has enabled downstream process scientists to achieve the necessary productivity. The proven strategies include the
use of platform technologies consisting of second-generation resins with increased capacity and velocity, and enhanced stability
to harsh cleaning and sanitization conditions.
ACKNOWLEDGEMENTS
The Polymer Chain Reaction (PCR) is covered by patents owned by Roche Molecular Systems and F Hoffmann-La Roche. A license
to use the PCR process for certain research and development activities accompanies the purchase of certain reagents from licensed
suppliers.
Gail Sofer is director of regulatory compliance for the life sciences business unit of GE Healthcare, 800 Centennial Avenue, Piscataway
NJ, 732.457.8000, gail.sofer@ge.com
Laura C. Chirica, PhD, is product manager, bioprocess, for the life sciences business unit of GE Healthcare, Björkgatan 30, 75184, Uppsala, Sweden,+
46 18 612 1990, fax: +46 18 612 1910, laura.chirica@ge.com
REFERENCES
1. Farid S. Established bioprocesses for producing antibodies as a basis for future planning. Adv Biochem Engin Biotechnol.
2006;101:1–41.
2. Wurm FM. Production of recombinant therapeutics in cultivated mammalian cells. Nature Biotechnol. 2004;22(11):1393–8.
3. US Food and Drug Administration. Guidance for industry, investigators, and reviewers: exploratory IND studies. 2006 January
[cited 2006 October 9, 2006]. Available from:
http://www.fda.gov/CDER/guidance/7086fnl.htm
4. Slaff G. Application of technology platforms to the purification of monoclonal antibodies. BioProcess International Conference;
2005 Apr 12–13; Berlin, Germany.
5. Phillips J, Liu J. Platform analytical approaches to monoclonal antibody development. BioProcess International Conference;
2005 Apr 12-13; Berlin, Germany.
6. Curtis S, Lee K, Blank GS, Brorson K, Xu Y. Generic/matrix evaluation of SV40 clearance by anion exchange chromatography
in flow-through mode. Biotechnology and Bioengineering. 2003;84(6):715–22.
7. Norling L, Lute S, Emery R, Khuu W, Voisard M, Xu Y, et al. Impact of multiple re-use of anion exchange chromatography
media on virus removal. J Chromatogr. 2005;1069(1):79–89.
8. Brorson K, Brown J, Hamilton E, Stein KE. Identification of Protein A media performance attributes that can be monitored
as surrogates for retrovirus clearance during extended re-use. J Chromatogr A. 2003 Mar 7;989(1):155–63.
9. Grönberg A, Monie E, Murby M, Rodrigo G, Wallby E, Johansson HJ. A strategy for development of a MAb purification platform.
BioProcess International European Conference; 2006 Feb 20-23; Prague, Czech Republic.
|
