From the earliest days of the biotechnology industry, companies have grappled with the complexities of making innovative biopharmaceuticals
on a large scale. Success in manufacturing begins with process science, since biotech production requires perfection in maintaining
living organisms in a sterile environment under controlled physiological conditions. But unless companies can solve the challenge
of planning for and managing manufacturing capacity, they will not be able to achieve the full potential of promising biotech
products.
Matching capacity with demand is complex and difficult. To pursue a promising drug, a company must begin building a manufacturing
plant several years before clinical research reveals the full safety, efficacy, and marketability of that drug. It's almost
impossible to forecast the capacity that will be needed in five years, and no organization can afford to incur the costs of
an idle plant—or lose sales because production capacity is inadequate. In fact, the industry's conventional wisdom bears that
out; only half of all plants currently manufacture the products they were built to make.
After 20 years of experience, most biotech companies have discovered that integrating process development and manufacturing
into a single organization saves time and money, and can make it possible to launch new products faster. A second way to gain
efficiency and shorten lead times in manufacturing—not as widely recognized—is global standardization.
Wyeth Biotech is a case in point. Since 2000, the company has invested $3.5 billion in building or renovating more than 20
manufacturing suites at six sites around the world. Because some Wyeth biotech products are manufactured at multiple facilities,
increased efficiency also requires harmonizing processes across global sites. For example, in Andover, Massachusetts, our
process development group is co-located with our manufacturing group to foster collaboration and improve synergies. There
and at other locations, we are creating technology platforms that reduce production costs, speed new products to market, and
expedite the development of new pipeline products. These platforms are standardizing a broad range of manufacturing steps
and materials, including production equipment, raw materials, fermentation processes, chromatography resins, batch records,
quality procedures, automation systems, and quality documentation. We believe such standardization not only will pay off with
a greater return on investment, but also will help us adapt to changing market demands.
In addition to standardizing, we are also improving productivity through science. Our proprietary fermentation technology,
for example, has substantially increased output. In the past, we needed ~100,000 liters of fermentation capacity to produce
a metric ton of product in one year. In the future, we expect to produce 10 grams of protein per liter. At this rate, a single
5,000-L fermenter could produce the same metric ton in one year. This technology is driving a transformation of the worldwide
requirements for biopharmaceutical manufacturing capacity and reshaping the way we plan and build biotech facilities in the
future. Our experience has shown that biology trumps stainless steel.
Science, improved processes, and standardization are transforming the industry and driving down the cost of commercializing
biotech products. In the future, I believe it will be easier, faster, and less expensive to manufacture biotech products than
ever before. These improvements will lower the risk on investment and reduce capital requirements, bringing enormous potential
and opportunity for this industry for decades to come.
Michael E. Kamarck, PhD, is the senior vice president of Wyeth Biotech Technical Operations and Product Supply, Collegeville, PA, kamarcm@wyeth.com
