The Birth of Bioproduction at UC Berkeley
by David Pescovitz
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"In
IEOR, the devices in the systems we work on are on the scale
of factories, hospitals or airports," Professor Lee Schruben
says. "Our units of measure are not Joules or Ohms, but
social resources such as time and money."
Peg Skorpinski photo
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When Berkeley
professor Lee Schruben attended a conference celebrating the opening
of Berkeley's new Department of Bioengineering, he was duly impressed.
One after another, researchers highlighted new research on methods
to treat myriad diseases that could someday save "millions
of lives." But as much as Schruben, the chair of the Department
of Industrial Engineering and Operations Research (IEOR), was impressed
by the presentations, he was also concerned. A new drug to combat
multiple sclerosis, for example, is only a lifesaver if it gets
to the patients who need it at a cost they can afford. This is a
problem, Schruben realized, that falls squarely in the IEOR domain.
"The question is how do you efficiently and cost-effectively
mass produce high quantities of a high-quality product and get it
into the supply chain," he says. "Those are traditional
industrial engineering research topics. But in academia, very few
people are applying IEOR methods to biotechnology."
To that end, Schruben and IEOR professors Robert Leachman and Philip
Kaminsky are undertaking a UC Berkeley initiative in bioproduction,
the way in which biopharmaceutical firms manufacture and distribute
their wares. Schruben and Leachman are experts in semiconductor
manufacturing while Kaminsky is a recognized authority in supply-chain
management with experience in the pharmaceutical industry. Eventually,
Schruben hopes the College will offer a certificate program or even
a degree in the field. Kaminsky is spearheading an effort to co-host
a National Science Foundation-sponsored bioproduction symposium
later this year, the first step in Schruben's vision for a Berkeley-based
international consortium of biopharmaceutical production researchers
and manufacturers.
The IEOR Department's bioproduction research efforts have already
begun through collaborations with scientists at the bio-pharma
plants of Chiron Corporation and Bayer. The Berkeley researchers
agree that biotechnology is at a similar crossroads as the semiconductor
industry faced several decades ago. Amazing new products are being
discovered so fast that the cost and quality issues associated
with good production and distribution methodologies are now secondary
concerns. When production ramps up to high volume though, those
issues become critical.
"The issues of quality, production, materials, and supply-chain
management that we have had great success with in semiconductor
operations appear to be very similar to those in bioproduction,"
Schruben says. "But the biotech companies also have the Food
and Drug Administration looking over their shoulders at not only
product quality but their manufacturing methods. There are also
some new and challenging quality control issues here."
Schruben
models complex systems, from semiconductor plants to health
care systems, with greater speed and accuracy.
Peg Skorpinski photo
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Schruben points
to a 2002 article in Fortune magazine detailing a hit Bayer took
several years ago when FDA inspectors found major faults with the
manufacturing methods the company was using to produce a certain
hemophilia treatment. The necessary corrective steps drastically
slowed production of the drug, leading to a rationing and a cloud
of fear falling over the patients who counted on the drug for their
very survival.
"Because we were very enamored of our science, we weren't necessarily
paying attention to good manufacturing practice," a Bayer vice
president was quoted as saying in the Fortune article.
Bayer of course bounced back, but the tale, Schruben says, proves
that bioproduction is tricky business. The facilities grow their
products from living cells, often using large bioreactors where
protein drugs are fermented. Alternately, they employ a continuous-flow
process where the products are drawn from smaller reactors over
a period of months. In either case, as in microchip fabrication,
even the tiniest contaminant can ruin an entire batch.
"Because you use one batch to make the next batch, a product
may be well into its production process before you find out it's
bad," Schruben explains. "So you need to take a risk,
but you need to do it without going too far down the production
process. In IEOR, we specialize in quantifying such production
risk trade-offs."
The Berkeley researchers believe that they can make big improvements
in this kind of quality assurance. Like integrated circuit manufacturing,
the end products, in this case proteins, are not visible to the
naked eye so all inspections must be done indirectly using high-tech
metrology, or measurement, devices. Additionally, the researchers
are exploring ways to improve the production schedule of bio-pharma
facilities. The aim is to improve the plants' capabilities to efficiently
manufacture several products using the same equipment while efficiently
scheduling in necessary decontamination cycles.
Drawing from his experience in semiconductor manufacturing,
Schruben's goal is to create a bio-pharma version of SEMATECH, the
Austin, Texas-based consortium for the international semiconductor
industry where he served as visiting Distinguished Professor in
1992. A bioproduction consortium would share best manufacturing
practices while driving necessarily cross-disciplinary manufacturing
and production research in all areas of the industry.
"In addition to the economic benefit similar to what SEMATECH
provides to the semiconductor industry, this effort has a moral
imperative," Schruben says. "It's the only way bio-pharma
is really going to save millions of lives."
Lee
Schruben's Home Page
Robert
Leachman's Home Page
Philip Kaminsky's Home Page
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Updated 8/29/03.
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