Generally, large organizations such as Wyeth can take on the risk of experimenting with manufacturing and process engineering. Since 2000, Wyeth has invested $3.5 billion in building or renovating more than 20 manufacturing suites at six sites around the world. Two of these sites, Grange Castle, Ireland, and Andover, Massachusetts, have become models for integrated process development and manufacturing. The co-location of process development and manufacturing groups helps foster close collaboration and creates an atmosphere of innovation. Basic research is conducted to improve and push the limits of biopharmaceutical production by methods such as assessing alternative expression and operational systems, as well as enhancing workflow efficiencies. Through standardization and improvements in the biology of protein expression, Wyeth is significantly increasing yields while enabling single bioreactors to handle more products, and reducing the need to expand equipment and facilities. The ability to increase capacity and flexibility in current internal manufacturing facilities has been instrumental in Wyeth's strategy to increase its portfolio of biologics and its ability to put as many as eight to ten biopharmaceutical candidates into the clinic each year.

Within the biotechnology industry, there has been little incentive to develop a deeper scientific understanding of manufacturing processes in an effort to improve quality and efficiency. This may be due in part to strict requirements on the part of regulatory authorities, who are concerned that any process change could present an unacceptable risk. Recently, however, the FDA, in the form of its Critical Path Initiative, has signaled a desire to foster innovation in manufacturing and other stages of drug development to get valuable drugs to patients sooner. Such policy changes have paved the way for new technologies that have gained prominence for boosting efficiency. For example, disposable bag bioreactors simplify processing, inoculum trains, scale-up, and turnaround times while saving the time and cost of sterilization, cleaning and validation; innovative expression systems secrete proteins or concentrate proteins within cells for later extraction at high yield; and precise control of bioreactor environments can lead to high cell densities.

THE FUTURE MAY HAVE ALREADY BEEN HERE

To get a glimpse of what the future may hold for the biopharmaceutical industry, one need only look back to the transformation that took place in semiconductor manufacturing. Similar to the biotechnology industry, the technology for semiconductor manufacturing was initially highly specialized and expensive. Competitive pressures and the need for large-scale production required the construction of large plants, at costs that were prohibitive for most industry companies. The investment in such large plants led to a compromise in the ability to rapidly respond to new technological advances. To better respond to markets and compete with lower cost operations in Asia, semiconductor companies began to form consortia to share capacity and hire contract manufacturers. As in the biotechnology industry today, shared capacity in semiconductor manufacturing was only possible through the standardization of processes and technology. Technology standardization became more firmly established as the small number of companies, which held the dominant intellectual property required for the design and manufacture of state-of-the-art semiconductors, became the industry leaders.