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This growing industry has been compared to the intersection of two tectonic plates,
where life science and engineering meet, and where the factory is a living cell.
Spawns a
DEMAND
for Engineering Skills
By Charlotte Thomas, SWE Contributor
B
iotechnology is gaining momentum
and clout in the United States,
although its parameters are still not
clearly defined. Just what is biotechnology and where do engineers and engineering employment fit into the scheme?
From a broad perspective, biotechnology
can be considered “the use of biological processes and technology to solve problems or
make useful products,” as the Biotechnology
Industry Organization explains. According to
Cathy Hood, manager for the American
Institute of Chemical Engineers and the soonto-be-announced Society for Biological
Engineering, biotechnology is more of an evolution in industry and academia rather than a
strictly defined process.
“It’s difficult to define because it’s so
expansive,” says Bo Crouse-Feuerhelm, associate and director of client services at CRB
Consulting Engineers and past president of
the Carolina - South Atlantic Chapter of ISPE
— the society for life science professionals.
“Biotechnology is the use of many technologies that use living organisms to solve
problems and make products that enhance
health care, agriculture, energy, the environment, and our food. We’re using and relying
on biotechnology more than we ever
envisioned.”
Even in regional biotechnology organizations, directors like Debbie Hart, president of
the Biotechnology Council in New Jersey, say
that depending on whom you talk to, the definition of biotechnology can change. “Is it
nanotechnology or medical devices?” she
comments about the questions that are raised
about potential members of their association.
Watching the merger of information technology and computer graphics in the biotech
mix, Kenneth Morse, managing director of the
MIT Entrepreneurship Center compares the
growing industry to the intersection of two
tectonic plates — where engineering and science meet. For instance, the biological discoveries of compounds that activate changes in
the temperature of the brain stem, and the
computerized ability to read those changes in
real time are producing solutions to diseases
such as Alzheimer’s. “It takes engineers and
scientists to build the equipment, and geniuses
to run them,” he quips.
The state of the industry —
slump or surge?
While the definitions of biotechnology
evolve, its growth as an industry is equally
hard to nail down. According to the Ernst &
Young’s “Beyond Borders: The Global
Biotechnology Report 2003,” the industry is
simultaneously struggling and succeeding.
Despite several Wall Street slumps in the
past 20 years, the Biotechnology Industry
Organization projects positive overall
growth trends. Noting the same fluctuations
in its 17th annual report on the life sciences
industry, “Biotech 2003: Revaluation and
Restructuring,” Burrill & Co. a life sciences
merchant bank, makes the following observation: “Due to Wall Street investors fleeing
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MELODY SPRADLIN
Senior Manager
Project Engineering Lab and Office Group
Genentech Inc.
San Francisco, California
B.S. in general engineering
M.S. Civil Engineering
M.S. Business
What made you choose biotechnology over
other career paths?
Initially I was in civil engineering in the Navy. Then I
went to Stanford University for graduate school and
worked for a general contractor. I initially built one office
building and then specialized in constructing biotech facilities. I learned that the key to advancing in biotech was
based on knowledge, not just years in service. In biotech
facility construction, you can alter your career by seeking
additional knowledge about the science or production
operations. You become a better designer and builder of
biotech facilities by understanding the process that occurs
within. The fields in biotech are as diverse as the operations and science that occur within the facilities. Career
moves are generally more time-based in high-rise construction. The major aspects of most office buildings are
similar. Progression is based on participating in various
roles of increasing responsibility on high rise projects,
which takes time, versus knowledge of science and
process.
Another reason is that you feel good about what you do.
At Genentech, I design and build projects that impact the
lives of people with psoriasis, asthma, heart problems and
cancer. A lot of people in biotechnology are motivated by
personal drive.
What’s your biggest challenge?
Time. In general with biotech jobs, you don’t make the
investment in a facility until you know the drug will work.
It’s a push to get the facility done and motivating to be
involved in something that makes such a difference. I
know if there’s an impure pipe or
the facility is late, it will affect people’s lives.
Is biotechnology a good field for
engineers to consider?
It is diverse. With biotechnology,
there is a broadness to what you’re
doing, from helping out the process
and mechanical parts to automation
and data collection and controlling
the environment.
Melody Spradlin, senior manager for the
Project Engineering Lab and Office Group
at Genentech Inc., with colleagues on the
construction site of Genentech’s
Founders Research Center. With more
than 600,000 square feet, it is the largest
biotechnology research facility of its kind
in the world. From back standing: Vicki
Hillyer, Cindy Burgess, Melody Spradlin,
Julie Ma. Front row: Betty Sun, Karen
Reutlinger, Debbie Sit, Denise Houchens.
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the sector for lower risk propositions, the
industry has become leaner and meaner
and in some ways stronger than at any
other time in its history.”
Innovation and breakthroughs
invigorate the industry
A significant factor causing growth in
biotechnology is a wave of research and
development poised in the pipeline to generate new products in health care, agriculture, industrial production, and environmental management. Doug Getter, executive
director of the Iowa Biotechnology
Association, suggests that the biotechnology
industry is at the same point of innovation
as the computer industry was in the early
80s. Now that computing power can go into
the genetic structure of humans or livestock,
a whole new industry of bioinformatics has
sprung up. By applying information technology to biology, advancements can be
faster and more precisely brought to fruition
as trial and error are reduced.
With a shortened timeline for products to
get from research to profitability, biotechnology is becoming a more viable opportunity
for venture capital investors. In addition, university researchers, who generate much of
the innovation, can now use the rich public
databases of biological information.
According to Ernst & Young, “Successful
companies will be those that improve their
efficiencies in translating research discoveries
into innovative products.”
A few hurdles to clear
before the boom kicks in
Though looking rosy, the future for
biotechnology is encountering some rough
patches. While the industry has not suffered
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el of payback,” states Getter.
BETH WESCOTT
Director, rFIX Drug Substance Manufacturing
Wyeth BioPharma
Andover, Massachusetts.
Degrees: B.S. and M.S. Chemical Engineering
How can someone transition into
the biotechnology field?
It depends on the discipline. For instance, if you are a
mechanical engineer, electrical engineer, or chemical engineer, or if you’re in a discipline involved in the upkeep of
facilities and systems, the transfer is easiest earlier in your
career. I had been out of school for 10 years when I made
a conscious decision to move into this industry from the
petroleum industry. I started here as a plant engineer and
have moved into manufacturing in a management role.
What attracted you to this field?
Part of the decision was a desire to move to the New
England area. The other attraction is being able to contribute to a higher idea. In the refinery, you’re “fueling
America’s dreams.” Here, I work to enhance life and the
quality of life. Because of this industry and our products,
children can live active and wonderful lives.
What do you find challenging
about biotechnology?
It comes down to making
sure you have the highest quality product for the patients.
There are always improvements to be made, and we’re
continuously balancing business considerations to best
apply finite resources.
Beth Wescott, Director, rFIX Drug
Substance Manufacturing
the same downturn of venture
capital as did the high-tech industry, its
progress is still slowed by the regulatory process inherent in drugs used by humans as
well as the time needed for a product to go
from discovery to reality. “The challenge for
the industry will be the regulatory environment. As a consumer, I wouldn’t want it any
other way, but there are tremendous hurdles
in terms of bringing drugs to market,” notes
Paula Soteropoulos, senior director of operations at Genzyme Corporation. Industry
observers predict that if the regulatory issues
can be dealt with in the near future, the
industry may achieve profitability by 2010.
Products coming out of the research and
development phase must be protected with a
patent, and then worked through development, then into clinical trials and production.
“There are a few that make it through and
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How do engineers fit
into biotechnology?
As biotechnology goes through the fits and
starts of any up-and-coming industry, the
role of the engineer is increasing.
Considering the advances in analysis that
engineering has brought to biotechnology,
Natacha DePaola, associate professor in the
biomedical engineering department at
Rensselaer Polytechnic Institute, comments,
“Engineers don’t just build bridges. Now
we can look at molecules.” Biotechnology
has become the meeting ground between
the life sciences and engineering, and as the
industry matures, more and more engineers
will be demanded to apply the tools of engineering.
Speaking from a pragmatic standpoint of
the engineer, Getter states, “Nothing is
going to happen until you can put the process together from an engineering point of
view. It’s great to have chemistry, but it
works in a test tube. Engineers translate the
test tube into bench scale and pilot plant
capability and ultimately into production
facilities.”
The intriguing challenges
of biotechnology for engineers
What makes biotechnology interesting for
engineers is applying solid engineering principles to groundbreaking scientific discoveries. In her job as director of operations,
Soteropoulos works with scientists whom she
says are “traditionally more innovative and
think out of the box.” Engineers provide an
environment that reduces the cost to the
patient by balancing the cost and regulatory
requirements.
Coming from the petroleum industry as a
chemical engineer into biotechnology, Beth
Wescott, director of rFIX Drug Substance
Manufacturing at Wyeth BioPharma, finds
the scale of biotechnology fascinating. In the
refinery where she previously worked, she
processed hundreds of thousands of barrels
of products a day. “Here,” she says, “we
process to obtain liters of purified protein.
Our factory for our product is a living cell,
which introduces a whole different level of
complexity.”
What’s driving the growth
of engineering employment?
According to Wescott, many protein pharmaceutical products are now in clinical trials
and preparing to move into commercial manufacturing. Before products for human consumption go through FDA approval, they
must pass clinical tests of fundamental safety
and then proof of concept to make sure the
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The Numbers of Biotech Growth
Overall global biotech revenues increased 15 percent to more than $41 billion.
R&D expenses jumped 34 percent to more than $22 billion in the past year.
More than 50 percent of revenues are being reinvested in R&D activities.
The U.S. recorded 16 percent compounded annual growth rate in revenues since 1989.
Biotech companies have brought more than 150 breakthrough medicines to patients in less than three decades and
have increased revenues by $4 billion in the last year alone.
From Ernst & Young, “Beyond Borders: The Global Biotechnology Report 2003”
The Technologies and Their
Applications:
◆ Bioprocessing Technology
◆ Monoclonal Antibodies
◆ Cell Culture
◆ Cloning
◆ Recombinant DNA Technology
◆ Protein Engineering
◆ Biosensors
◆ Bio-nanotechnology
◆ Microarrays
Number of Biotech Companies, 1992-2001
Not only have individual companies grown over the last 10 years, the number of
U.S. biotech firms has continued to climb, approaching 1,500 in 2001.
Biotechnology Tools in
Research and Development:
◆ Research Applications
(Includes stem cell technology,
cloning, microarray technology,
antisense and RNA interference,
and gene knockouts)
◆ Putting the Pieces Together:
‘Omics’
(Genomics, proteomics and bioinformatics)
◆ Product Development Applications
Source: Ernst & Young Reprinted from Biotechnology Industry Organization Web Site
http://www.bio.org/investor/signs/200210rv5.asp
Health-Care Applications:
◆ Diagnostics
◆ Therapeutics
◆ Regenerative Medicine
◆ Vaccines
◆ Genomics and Proteomics
◆ Approved Biotechnology Drugs
Agricultural Production Applications:
◆ Crop Biotechnology
(Includes production improvement, impact on developing
countries, environmental and economic benefits and
regulations)
◆ Forest Biotechnology
◆ Animal Biotechnology
(Includes companion animals, applications for human
medicine, and environmental and conservation efforts)
◆ Aquaculture
◆ Additional Uses of Marine Biotechnology in
Aquaculture:
• Global Area of Transgenic Crops, 1995 to 2002:
Industrial and Developing Countries
• Global Area of Transgenic Crops in 2001 and 2002
by Country
• Global Area of Transgenic Crops in 2001 and 2002
by Crop
• Global Area of Transgenic Crops, 1996 to 2002, by Crop
• Global Area of Transgenic Crops in 2001 and 2002
by Trait
• Global Area of Transgenic Crops, 1995 to 2002, by Trait
• Transgenic Crop Area as Percentage of Global Area
of Principal Crops
• Global Status of Biotech Crops in 2002
◆ Agricultural Biotech Products on the Market
Food Biotechnology:
◆ Improving the Raw Materials
◆ Food Processing
◆ Food Safety Testing
Industrial and Environmental Applications:
◆ Industrial Sustainability
◆ Biocatalysts
◆ Renewable Energy
◆ Green Plastics
◆ Nanotechnology
◆ Environmental Biotechnology
◆ Industries That Benefit
◆ Examples of Industrial Enzymes
Homeland Defense and National Security:
◆ Policy
◆ A Strategic Asset
Vaccines, monoclonal antibodies, DNA- or RNA-based
therapeutics, and detection and diagnostics
◆ Other Approaches
Other Uses:
◆ DNA Fingerprinting
◆ Space
◆ Plant-Made Pharmaceuticals
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GRACE LEE, PH.D.
Process Engineer
CRB Consulting Engineers
St. Louis, Missouri
Degree: Ph.D. Chemical Engineering
What do you like about biotechnology?
The possibilities are intriguing. Cells are complex.
They’re not neat little packages but have lots of avenues to
explore. If you understand how cells work, you can make
them do what you want them to do. It’s an efficient way to
make a lot of drugs and useful materials.
When I was in graduate school, I was looking at things
on the cellular level inside the cell. Now I’m working at the
big tank picture. I deal with mass transfer problems and
heat transfer problems. That’s a completely different set of
problems in dealing with the same organisms. Each project has different organisms and different products so there
are always nuances about a project and changes to be
addressed.
Where do you see the biotechnology industry going?
There are so many options. They’re finding new drugs
and new methods all the time. The challenge is how do we
address different processes on a larger scale in different
ways? One example is cell separation. When I worked with
a smaller bioreactor and wanted to separate product from
cell broths, I used reverse
osmosis. The product passes
through the membrane while
the cell debris and other
molecules are too large to pass.
As the process gets larger, we
have different issues. We’re
making filters that haven’t been
made before on a scale that’s
never been done before.
Grace Lee, Ph.D.,
Process Engineer
product acts the way it is supposed to in
humans. Taking a look at the public records
of what products are now in the late clinical
trial stage, Wescott speculates that the projection for capacity may be tight, which is good
for engineering employment.
Another significant factor is the human
genome project, which opened a floodgate
of potential and the need for people who
are trained as computer engineers and can
deal with volumes of biological information.
From the AIChE Society for Biological
Engineering, Hood cites the unique strengths
that engineers have which facilitate the
growth and innovation in biotechnology.
Chemical engineers, she points out, are in a
position to connect the diverse segments of
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biotechnology and to bridge science and
industry.
Almost every sector of biotechnology hires
engineers: biopharmaceutical and pharmaceutical, biomedical, agricultural, food processing, chemical and materials, bioenergy
and fuels, and forest products. And many
disciplines are used in biotechnology: chemical, biochemical, biomedical, mechanical,
computer, agricultural, materials sciences,
electrical, and civil. “Right now,” states
Crouse-Feuerhelm, “the biggest hotbed for
engineers is the human health side of
biotechnology.”
Kathleen Kennedy, vice president of education and training at the North Carolina
Biotechnology Center, agrees that of the
many different biotech product areas, the
largest is the pharmaceutical. Typically not
that many engineers work in research and
development except those in companies
that are bringing new products to the market. They hire research engineers for new
product development. Process development
has engineers and scientists working
together.
The rush to build biotech facilities
“You have to have facilities, biotech
doesn’t work by science alone,” says CrouseFeuerhelm. What makes facility construction
challenging for engineers are the long lead
times for equipment delivery, special
demands placed on the utilities, such as a
million gallons of water a day, or electrical
power that must be reliable.
“Because of FDA regulations, there is
much specialization in terms of how facilities
need to be designed and built,” reports
Kennedy. “Not only the design and construction, but also the FDA demands good manufacturing practices that must be validated
and commissioned.” Comparing the shortage
of capacity for biopharmaceuticals and the
new products in the FDA approval pipeline
with the manufacturing capability, she says,
“Everyone is scrambling to attract building
plants.”
The need for specialized tools
As the time from bench to consumer is critical, testing data and information is critical.
“Say you have 10,000 genes. How are you
going to test those in a lab,” questions
Professor Sangeeta Bhatia, director of the
microscale tissue engineering laboratory in
the department of bioengineering at the
University of California, San Diego. “There’s
growth in the tool companies for drug discovery and companies building instruments
whose main goal is to test candidate drugs in
rapid automated fashion.”
Many small companies are filling that gap
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DIANNE MILIANTA
Assistant Vice President
Worldwide Operations Manager
Cargill Acidulants
Eddyville, Iowa
Engineering education: B.S. chemical engineering
What industry areas does agricultural biotechnology
cover?
It’s a broad area that goes from genetically engineered
crops and seeds, to animal husbandry, to biofriendly pesticides, to organisms and enzymes for food processing and
even biodegradable food packaging: from seeds to consumer.
I’ve done some fun things in my career. I have had the
opportunity to oversee the construction and start-up of
Cargill’s first ethanol plant as well as manage fermentation
production facilities in the U.S. and Brazil. I also manage a
team that started up a facility to produce the first non-shellfish derived glucosamine, Cargill Regenasure.
Glucosamine is used in the treatment of Osteo-Arthritis,
however current supplies are manufactured from shellfish.
Cargill Regenasure is a solution for individuals with shellfish allergies. This is a nice example of how biotechnology
can help people and improve their quality of life.
What do you find challenging about agricultural
biotechnology?
A challenge for the whole industry is the misinformation
in the public and in the media. Sometimes a quote will be
published that reflects a lack of knowledge of basic biology. Such misunderstanding can lead to a propagation of
irrational fear, which may result in missed opportunities to
employ ecologically friendly solutions for the environment
or even to dismissal of scientific data to allow for progress
against problems such as starvation, malnutrition, soil erosion, and pollution.
Another challenge is that biotech is a rapidly growing
field with new developments that feel like they’re being
made every day. The challenge is keeping up and being
vigilant in seizing opportunities created by new developments.
What kinds of opportunities do you see for engineers?
The nice thing about biotechnology is that any engineering discipline fits. It requires a
high level of technological
understanding and a desire to
continually learn. Engineers
are good at questioning to get
the details. Problem solving is
what you need in this fast
growing area.
Dianne Milianta,
Assistant Vice President
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by developing strategies that they then hope
to sell to the big pharmaceutical companies.
The goal is to develop platforms that the big
pharma companies aren’t developing inhouse themselves.
Bioinformatics, the merger of biology,
computer science, math, and engineering is
becoming such a significant sector of biotechnology that many engineering schools are
starting minors in the subject. Those in this
field deal with the large volume of information that biotechnology encompasses and
uses. Data mining is used to make sense of all
the data and provide a framework to extract
relevant information.
Universities gear up to handle
the need for engineers trained in
biotechnology
Rensselaer, for instance, is committing
tremendous resources of faculty and staff to
biotechnology and is currently building a
center for biotechnology and bioscience. “The
idea is not to just have a biotech center for
engineers, but to integrate them with scientists,” states DePaola.
MIT recently formed a biological engineering division. According to the description,
the purpose of the program is to “educate the
next generation of researchers in the fusion of
biology and engineering, bringing together a
powerful combination of measurement, modeling, and manipulation approaches toward
the objectives of understanding how biological systems operate.”
Hood reports that many other departments
of chemical engineering are modifying curricula to reflect the shared focus on biology
and chemistry in engineering. “The multidisciplinary nature of biotechnology creates
opportunities for collaborations among engineers and scientists,” she says.
Transferring engineering skills
to biotechnology
For those engineers who have already
graduated, making the transfer from traditional engineering functions to biotechnology
takes some adjustment and a learning curve,
but is very possible. Wescott came from the
petroleum industry and made a conscious
decision to get into biotechnology by taking
an orientation program that familiarized her
with the new field.
Grace Lee, a process engineer at CRB
Consulting Engineers, who comes from a
chemical engineering background, notes that
many of the basic skills apply. She says,
“There are different aspects you need to
understand and different standards, but the
equations are the same, just the equipment
changes.” Also coming from chemical engineering, Soteropoulos, points to the project
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PAULA SOTEROPOULOS
Senior Director of Operations
Genzyme Corporation
Cambridge, Massachusetts
Degree: M.S. Chemical Engineering
Paula Soteropoulos,
Senior Director,
Operations
What is engineering like in biotechnology?
Normally chemists and biologists are upfront in the
discovery but shortly thereafter engineers get involved.
Engineers are actually engineering the molecules more
than before,
My responsibility and operations cover manufacturing
products and development. I work with several internal
sites and with sales and marketing to look at product
needs. I am responsible for plants to produce the product
with the right capacity in place. As engineers we focus on cost.
That’s where we shine and bring value to corporations.
Is biotechnology a good field for engineers to consider?
Biotechnology companies are young, and I think they’re more profamily. You will find companies are better balanced than the more traditional established manufacturing companies putting out widgets.
By nature, engineers love to be innovative and be challenged to
solve problems. In biotech, the problems you are solving impact quality of life. You know you’re working on something that will help someone. We know what our products do and hear anecdotes and get
feedback from patients. In biotech, you feel you are having a greater
impact on the individual.
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management skills that
are needed in biotechnology as the door that
many engineers enter.
Companies are looking
for people who can
take programs from the
research and development side and manage
them to the product
side. “You might not
have specific experience in biotechnology,
but you use skills that
engineers use every
day,” she counsels.
For more details about how these
women engineers and others are
using their skills in biotechnology, see
the Engineering Snapshots interspersed throughout this article. ■
INDUSTRY TO GO
Biotechnology is as
portable as it is diverse.
Though the biotechnology
industry seems to gravitate to certain locations, those locations are
all over the world — Singapore to
Germany. As a knowledge-based
industry it flourishes with the right
combination of people and
resources, whereever they happen to be. “There’s tremendous
competition to be the next
biotech Mecca, which creates
some interesting dynamics,” says
Debbie Hart, president of the
Biotechnology Council of New
Jersey. According to Kenneth
Morse, managing director of the
MIT Entrepreneurship Center, it is
growing the most around leading
research centers.
Though biotechnology clusters
are popping up in Saskatchewan,
the major regions of biotechnology
in the United States cover:
California
Connecticut
Delaware
Illinois
Iowa
Maryland
Massachusetts
Michigan
New Jersey
North Carolina
Virginia
Washington, D.C.