The biopharmaceutical manufacturing renaissance has many implications. Companies will need to re-think their strategies and
capital investment in manufacturing facilities. More flexible capacity and higher yielding processes will reduce the need
to construct large plants for product launch. In addition, increased manufacturing flexibility will provide companies with
a higher level of protection against risks associated with lack of product efficacy in clinical trials or the redefinition
of its market through narrowed or expanded indications. For large companies with their own manufacturing facilities, issues
of managing plant utilization through capacity sharing or outsourcing may become less relevant. For emerging companies without
manufacturing infrastructure, outsourcing will remain an important resource. In addition, intellectual property for high-yield
manufacturing could become concentrated among a few industry players, who would then extend and disseminate standards in facilities
and processes through licensing, contract manufacturing, or building plants, in a process similar to what occurred in the
semiconductor industry. Lastly, the economic viability of targeted or small-market therapeutics will improve, possibly paving
the way for migration away from blockbuster drugs, which carry their own risks (e.g., major loss of revenue at patent expiration,
or withdrawal due to serious adverse events). The ability to serve smaller markets cost-effectively will also support the
movement toward personalized medicine, in which treatments are tailored to genetically defined subpopulations.
Many changes will occur as high production efficiency becomes the norm. So get ready, because it looks like the biopharmaceutical
industry is about to grow up.
Michael E. Kamarck, PhD, is the senior vice president of technical operations and product supply at Wyeth Biotech, Collegeville, PA, email@example.com
. At the same company, Louane E. Hann, PhD, is a senior program manager for strategic oversight of biotech process development, and S. Robert Adamson, PhD, is vice president of biotech process development.
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