New Expression Systems Create Opportunities for Innovators, CMOs, and Product Developers - But will concerns about regulatory issues, royalties, and return on past investments continue to impede indus

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New Expression Systems Create Opportunities for Innovators, CMOs, and Product Developers
But will concerns about regulatory issues, royalties, and return on past investments continue to impede industry adoption?


BioPharm International
Volume 22, Issue 3

TIME FOR CHANGE

It's not only manufacturing improvements that are driving the shifts toward new expression systems. Many in the industry have seen trends toward the use of R&D strategies to improve a biopharmaceutical's clinical performance. For example, Patrick Lucy, global business development leader at Dowpharma's Pfenex business, feels that expression system platforms play a part in clinical strategy. He believes that the use of new prokaryotic expression platforms will increase because of their short cycle time in the fermenter and ease of genetic manipulation. Lucy feels that biomanufacturers will shift for many reasons, one of which is that many companies have failed products on the shelves that, "could and should be made more efficiently, and to higher clinical standards in newer expression systems."

Indeed, interest in new biopharmaceutical mammalian expression systems appears to be growing rapidly. Andrew Sandford, vice president at Selexis (Geneva, Switzerland), an expression systems platform company, has noted this change. "Already, we have more than doubled the number of companies who have begun to actively change the way they plan their early development and manufacturing strategy," he says. "Many are starting process development four to six months earlier."

An analysis of the trends over the past decade reveals a decline in biopharmaceutical innovation. Oddly enough, in some cases, this is not because of a lack of new technologies. Rather, it is a failure to adopt these technologies and recognize the potential for future advancements and opportunity. Companies today are realizing that they cannot continue with the status quo and are being forced to make bolder choices. In biopharmaceutical manufacturing, the technologies needed to make improvements exist, and the benefits they can bring have been identified and documented.2 Given that these advantages include improved product yield, enhanced product quality, and lower operating and infrastructure costs, there can be no arguments about seizing such opportunities. In addition, these technologies can be applied to make products truly unique (difficult or impossible to copy), which should satisfy even the most stringent assessment of innovation.

Eric Langer is president and managing partner at BioPlan Associates, Inc., Rockville, MD, 301.921.5979,
He is also a member of BioPharm International's editorial advisory board.

References

1. Sixth Annual Report and Survey of Biopharmaceutical Manufacturing, 2008–2009, preliminary data. Rockville MD: BioPlan Associates, Inc.;2009.

2. Rader R. Biopharmaceutical Expression Systems and Genetic Engineering Technologies. Rockville, MD: BioPlan Associates, Inc.; 2008

3. Kermani F, Findlay G. The Application of Drug Delivery Systems. Centre for Medicines Research International;2000 Oct.

4. Pfizer [homepage on the Internet]. Pfizer Expects to Launch Three New Drugs in 1998, Company Tells Wall Street. New York: 1998 Oct. Available from: http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-30-97/348847&EDATE=.

5. AstraZeneca [homepage on the Internet]. AstraZeneca Progresses Key Products And Aims To Double Product Portfolio Value Every Five Years. London, UK; 1999 Dec 6. Available from: http://www.astrazeneca.com/media/latest-press-releases/1999/297?itemId=3892491.

6. CMR [homepage on the Internet]. The CMR International 2007 Pharmaceutical R&D Factbook. CMR International. London, UK; 2007. Available from: http://cmr.thomsonreuters.com/services/factbook.


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