Downstream Processing: Improving Productivity in Downstream Processing - - BioPharm International

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Downstream Processing: Improving Productivity in Downstream Processing


BioPharm International
Volume 19, Issue 11

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,

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,

REFERENCES

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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.

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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.

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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.


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