Where is Biopharmaceutical Manufacturing Heading? - An analysis of current and upcoming industry challenges. - BioPharm International

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Where is Biopharmaceutical Manufacturing Heading?
An analysis of current and upcoming industry challenges.


BioPharm International
Volume 21, Issue 10

CONCLUSION

Some industry experts see multi-ton MAb manufacturing looming on the horizon, but several important industry trends could actually reduce production scales. Therefore, lower-scale production approaches are needed. In the future, successful companies will have fewer ton-scale proteins and will look for economical ways to produce low-scale products. In addition, the pipeline of new products will require increased flexibility in manufacturing. The classic facility may become inadequate, and although companies will need to re-think their facility designs, they'll be reluctant to do so because of the time and money involved. A willingness to change will be essential, however, for everyone in the industry, including the manufacturers and suppliers.

Günter Jagschies, PhD, is senior director of strategic customer relations at GE Healthcare BioSciences, Uppsala, Sweden, +46.18.612.0000,

REFERENCES

1. Kelley B. Very large scale monoclonal antibody purification: The case for conventional unit operations. Biotechnol Prog. 2007 Sep–Oct;23(5):995–1008.

2. Tufts Center for the Study of Drug Development. Outlook 2006. Boston: Tufts University; 2006. Available from: csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2006.pdf

3. Curling JM, editor. Methods of plasma protein fractionation. New York: Academic Press; 1980.

4. Pharmaceutical Research and Manufacturers of America. 2004 Survey: Medicines in development: Biotechnology. Washington, DC: PhRMA; 2004. Available from: http://www.phrma.org/files/Biotech%20Survey.pdf

5. Pharmaceutical Research and Manufacturers of America. 2006 Report: Medicines in development: Biotechnology. Washington, DC: PhRMA; 2006. Available from: http://www.bioimpact.org/userfiles/PhRMA%20Survey%202006%20-%20Biotech%20drugs%20in%20devpt.pdf


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