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, kamarcm@wyeth.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.

1. Charlebois T. Frontiers and economics of mammalian cell expression. BIO 2006 Annual International Convention; 9–12 April 2006; Chicago, IL.

2. Kelley B et al. Designing a 10-ton mab process: Is conventional chromatography limiting? BiogenIDEC Manufacturing Seminar Series; Feb 2007; Cambridge, MA.

3. Luan Y-T. defined medium development for high yielding mammalian cell culture processes. BioProcess International Conference and Exhibition; Nov 2006; San Francisco, CA.