Conclusion
Large-scale GMP fermentation is a complicated undertaking and requires more than just a token commitment by a contract manufacturer.
It requires a commitment to excellence at each stage of the manufacturing and supply process, a substantial investment in
fermentation expertise and infrastructure, and a series of best practices across the broad spectrum of contract manufacturing
support services.
The investment in expertise, equipment, process, and quality control can be daunting; certainly enough so that many companies
are driven to seek outside supply for fermentation. By carefully defining project requirements, evaluating prospective suppliers
on objective criteria for fermentation specifically and contract manufacturing overall, and being willing to walk away if
there isn't a fit, a pharmaceutical company can rest assured it is taking the most rigorous steps possible to identify an
important partner in its product supply chain.
Sheryl Henderson is the director of Plant Network Strategy Implementation at Pfizer Inc., tel. 269.833.5667, fax 269.833.9106, sheryl.l.henderson@pfizer.com
Steven McWethy is the senior manager of the fermentation plant at Pfizer's Kalamazoo, Michigan, site. Keith Dixon is the director of bioprocess development at Pfizer.
*To whom all correspondence should be addressed.
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