CONCLUSION
The decision to outsource depends partly on a company's size. For a start-up or small biotech firm, outsourcing is a must,
but one that is not without risks and costs. For an established biotech company, outsourcing is an opportunity to:
- Work with the best experts, giving them the possibility to work on industrial molecules and models.
- Master the company's own process and improve understanding of its molecules.
- Favor partnerships and generate innovative processes and products.
- Generate additional scientific data to support complex requests from health authorities.
- Achieve cost benefits, when the outsource partner is solid in its processes (microbial fermentation, small molecules, anti-sense
peptides, etc.)
- Reach platinum quality standards, establish new intellectual property protection, and raise the bar for the quality attributes
of third-generation products.
ACKNOWLEDGEMENTS
I wish to thank my colleagues Dr. Avinoam Kadouri and Dr. Gianni Baer for discussing with me Serono's Biotech Process Development
Vision, and for their great help in the preparation of this manuscript.
Michele Antonelli, Ph.D., is senior vice president, manufacturing at Laboratoires Serono S.A., Zone Industrielle, CH-1267 Coinsins, Switzerland
0041.22.354.54.02, fax 0041.22.354.50.18, michele.antonelli@serono.com
.
REFERENCES
1. F. Kermani. The future looks outsourced. Pharmaceutical Technology Europe. Nov. 2004: 19-24.
2. Langer ES. Big shifts in outsourcing of biopharmaceutical manufacturing: half of manufacturers to outsource production
by 2008. Genetic Engineering News. January 2004. Available at http://
http://www.bioplanassociates.com/knowledge/outsourcing.pdf.
RESOURCES
1. Booth R. Extending your enterprise with outsourcing. BioProcess International. October 10, 2003: 14-18.
2. Heffner S. Outsourcing in drug discovery. Contract Pharma. November-December 2003.
Available at
http://www.contractpharma.com/NovDec033.htm.
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Available at http://bioplanassociates.com/knowledge/outsourcing.pdf.
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