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
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
In the computer industry, one can always state with confidence that the next year will bring improvements in manufacturing:
faster processors, more memory storage, and higher performance. This has rarely been the case for biopharmaceutical manufacturing.
Today, however, there is a palpable sense that a significant improvement in production efficiency is imminent. Wyeth is implementing
these improvements for its entire biopharmaceutical product portfolio with the ultimate goal of leading the industry. In the
future, we will see other major pharmaceutical and biotechnology companies increase their manufacturing capacity and flexibility
through the use of improved biological expression systems, innovative process technologies, optimized workflows, and standardization,
all without having to invest in additional stainless steel.
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.