News
Ann Arbor company files
details on drug production with FDA
August 30
Ann Arbor News
Ann Arbor-based GeneWorks, which hopes
to manufacture the key elements of prescription
drugs using chicken eggs, has taken
its first step in seeking federal approval
for its experimental processes.
The company's introductory filing to
the U.S. Food and Drug Administration
last week outlines its rare drug production
methods, which breed altered chickens
to manufacture pharmaceutical proteins
in their eggs. The whites of those eggs
can be used as the main compound in
certain medicines, according to the
company.
The filing is directed to the FDA's
Administration Center for Veterinary
Medicine and includes a detailed description
of the company's methods of introducing
specific genes to chickens. The submission
falls under the category of a new animal
drug.
The technical disclosure also contains
a description of GeneWorks' 156-acre
farm in Bridgewater Township and the
operations at its four high-tech barns
that house the experimental flocks,
which number about 3,000. The barns
are capable of accommodating more than
14,000 chickens.
Bill MacArthur, GeneWorks' president
and chief scientist, said the company
hopes to have enough animals to make
its first supply of pharmaceutical compounds
next year. The firm, which has gained
more than $18 million from investors,
has yet to sell any products. But the
company hopes to generate revenue by
producing bulk levels of medicinal compounds
for potential pharmaceutical partners.
GeneWorks believes its process can lead
to more efficient and cost-effective
production of drugs.
The FDA requires biotechnology companies
working with genetically altered animals
to file documentation and submit to
inspections. The regulations are designed
to keep genetically altered animals
from making their way into the food
supply, a concern raised by some scientists
and environmentalists.
August 11
Virginia Tech press release
Blacksburg, Va. -- The economics of
producing biopharmaceuticals from transgenic
plants such as tobacco is still a roadblock
to producing large quantities of urgently
needed medicines, especially for people
in underdeveloped nations.
Chenming (Mike) Zhang is testing a variety
of ways to economically recover recombinant
proteins from transgenic tobacco using
different protein separation techniques.
Zhang, an assistant professor in the
Department of Biological Systems Engineering
(BSE) in the College of Engineering
at Virginia Tech, is working with a
team of three Ph.D. students to develop
transgenic tobacco plants able to express
recombinant proteins economically. Recombinant
proteins are potential therapeutic agents
for treating human and animal diseases
and creating new vaccines. Plant-made
vaccines are especially beneficial because
plants are free of human diseases, reducing
the cost to screen for viruses and bacterial
toxins.
"Recombinant protein production
from transgenic plants is challenging,
not just from the molecular biology
aspect of creating high expression plant
lines, but also from the engineering
aspect of recovering and purifying the
proteins economically -- the importance
of which cannot be overlooked,"
Zhang said.
Recombinant proteins are proteins expressed
by a host other than their native hosts.
For example, if the gene for human growth
hormone is inserted into the genetic
code of yeast (gene recombination),
then the corresponding protein expressed
in the yeast is called recombinant human
growth hormone.
Zhang's research starts with introducing
the genes of interest into tobacco plants
and then developing economical processes
for recovering and purifying the expressed
proteins. Relaxin, one of the proteins
his team is studying, could potentially
benefit patients with asthma, hay fever,
and even cardiovascular disease.
Because most recombinant proteins are
for therapeutic uses, they need to be
highly purified to be safe for human
use. Thus, once a protein is expressed,
whether by transgenic tobacco or bacteria,
the protein first needs to be recovered
into liquid solutions before purification.
"Because of the high purity required,
the purification is rigorous and not
surprisingly, very expensive. Therefore,
development of more economical techniques
for protein purification is always an
engineering challenge in order to lower
the cost of therapeutic proteins or
biopharmaceuticals," Zhang said.
Zhang uses tobacco in his research
because it is a non-food crop and is
well suited as a "factory"
for recombinant protein production.
The leafy green tobacco plant is relatively
easy to alter genetically and produces
thousands of seeds and a great deal
of biomass. As a non-food crop, genetically
manipulated tobacco will not pose a
safety threat to products consumed by
humans. "Since tobacco is neither
a food nor a feed-crop, transgenic tobacco
will not enter our food chain,"
Zhang said.
The research is funded by the Jeffress
Memorial Trust and the Tobacco Initiative.
Zhang is the director of both the Protein
Separation Laboratory and the Unit Operations
Laboratory at Virginia Tech. The Protein
Separation Laboratory supports research
in protein expression and purification
process development from transgenic
plants and other expression systems.
The Unit Operations Laboratory supports
a course by the same name taught by
Zhang in biological systems engineering.
He is also affiliated with the Virginia
Tech-Wake Forest University School of
Biomedical Engineering and Sciences.
The College of Engineering Dean's Award
for Outstanding Assistant Professor
was presented to Zhang in 2004. His
nomination was based on his extraordinary
level of activities and accomplishments
in curriculum development and teaching,
development of a viable research program,
and his cooperative efforts with colleagues
at Virginia Tech and around the nation.
Before coming to Virginia Tech in 2001,
Zhang was a research and development
scientist for two years at Covance Biotechnology
Services (now Diosynth RTP) in Cary,
N. C.
Zhang received his bachelor's and master's
degrees in metallurgical physical chemistry
from the University of Science and Technology
in Beijing, China, in 1986 and 1991,
respectively. He received a second master's
degree in physical and analytical chemistry
in 1996 from Iowa State University as
well as his Ph.D. in chemical engineering
in 1999.
The College of Engineering at Virginia
Tech is internationally recognized for
its excellence in 14 engineering disciplines
and computer science. The college's
5,600 undergraduates benefit from an
innovative curriculum that provides
a "hands-on, minds-on" approach
to engineering education, complementing
classroom instruction with two unique
design-and-build facilities and a strong
Cooperative Education Program. With
more than 50 research centers and numerous
laboratories, the college offers its
2,000 graduate students opportunities
in advanced fields of study such as
biomedical engineering, state-of-the-art
microelectronics, and nanotechnology.
August 6
Environment News Service
The U.S. Agriculture Department must
disclose the Hawaiian locations of experimental
crops that are genetically modified
to grow pharmaceuticals, a federal judge
ruled Wednesday.
Chief Judge David Ezra agreed with the
plaintiff Center for Food Safety, represented
by the public interest law firm Earthjustice,
that the locations of the so-called
biopharm crops is not confidential proprietary
business information.
The lawsuit was filed in federal district
court in Honolulu in November 2003 asking
the court to order the U.S. Department
of Agriculture (USDA) to assess the
environmental and public health risks
of, and better regulate, the open air
testing of biopharmaceutical crops in
Hawaii and throughout the United States.
This is the first time in the United
States that locations of biopharm tests
will be revealed to an outside party.
Similar disclosures in other states
might follow for biopharm crops and
possibly for all genetically modified
crop research.
In Hawaii, Monsanto Co., the Hawaii
Agriculture Research Center, ProdiGene
Inc. and Garst Seed Co. have been granted
permits to test biopharm crops.
Under Judge Ezra's order, the locations
of the experimental fields will be disclosed
to Earthjustice, which must keep the
information confidential for at least
90 days.
Hawaii has more than 4,000 field test
sites for genetically engineered crops,
more than anywhere else in the world,
including more than two dozen tests
of biopharm crops, Earthjustice says.
Biopharm crops are genetically engineered
to produce pharmaceuticals, industrial
chemicals, and other medical and industrial
products, including a blood clotting
agent, a blood thinner, various blood
proteins, experimental animal vaccines,
industrial enzymes, antibodies, and
a potent abortion-inducing compound
once considered for use as an AIDS drug.
Earthjustice attorney Isaac Moriwake
argued that none of these biopharm crops
has been approved for human or animal
consumption, or even for general release
into the environment.
Yet the USDA allows these tests to
be conducted in open fields, conceals
the trials’ locations from the
public, and in most cases refuses to
disclose the substances being grown.
Moriwake says the tests use food crops
like corn and soybeans, increasing the
risk of contaminating the food or livestock
feed supply with powerful, biologically
active chemicals. The tests also pose
a serious hazard to endangered plants
and animals, of which Hawaii has more
than any other state.
Grocery Manufacturers of
America concerned about ProdiGene's
plans to grow biotech corn in Texas
August 6
Des Moines Register
Washington, D.C. - A biotech company
is seeking federal approval to begin
regular production of pharmaceutical
corn crops, a move that has alarmed
the U.S. food industry.
The Texas-based company, ProdiGene
Inc., gave the biotech industry a black
mark two years ago when it was caught
mismanaging field trials of genetically
modified crops in Iowa and Nebraska.
ProdiGene, which is commercializing
two medical products made from bioengineered
corn, has asked the U.S. Agriculture
Department to allow cultivation of the
crops in Frio County, Texas, a thinly
populated area southwest of San Antonio.
The Grocery Manufacturers of America,
which represents such brands as Kellogg,
General Mills, Kraft and Gerber, opposes
the application. In a letter July 28
to the USDA, the trade group said the
government provides inadequate oversight
of crops engineered for pharmaceutical
and industrial purposes.
"We have long memories of the
potential impact this can have on our
companies," said Stephanie Childs,
a group spokeswoman.
Some food companies were required to
do nationwide recalls three years ago,
after a variety of biotech feed corn
not approved for human consumption,
StarLink, was found mixed with supplies
of food-grade grain.
ProdiGene officials did not return
calls seeking comment.
ProdiGene was forced to pay the government
about $3 million in penalties and cleanup
costs for failing to prevent its pharmaceutical
corn plants from getting mixed with
crops intended for food or animal feed.
ProdiGene's problems, coupled with
tighter planting rules imposed by the
USDA in 2003, dealt a sharp setback
to Iowa's hopes of developing bio-farming.
A taxpayer-financed Iowa investment
fund bought into ProdiGene in 2001.
Last year, a subsidiary of Iowa-based
Stine Seed Co. purchased a majority
ownership in ProdiGene.
However, the food companies' opposition
to ProdiGene's Texas plans highlights
the industry's concern about biotech
crops.
There were no field trials of pharmaceutical
crops in the state last year, and this
year there is just one, which involves
barley, not corn.
The Grocery Manufacturers of America
said the Food and Drug Administration
should evaluate the safety of pharmaceutical
or industrial crops before they are
approved for cultivation.
"Right now, as it stands, federal
regulations say that if any of these
plant-made pharmaceuticals make it into
the food supply, we have an adulterated
product," Childs said. "It's
our brands that get damaged. We're not
ready to take that risk for a product
that we're not developing."
The USDA took the unusual step of writing
environmental assessments for the ProdiGene
crops because the company plans repeated
plantings during the next several years.
USDA analysts concluded there would
be little health or environmental risk
from the corn crops, in part because
little other corn is grown in Frio County.
Although the location was not disclosed,
the ProdiGene crops will be at least
a mile away from any other corn with
which they could cross-pollinate, the
studies said.
The corn would be used to manufacture
trypsin, used for insulin, vaccines
and other products, and aprotinin, which
also has a number of medical applications.
Both products are now derived from cattle
tissue.
The company will inspect the crops
weekly at first and then daily during
pollination, the USDA said. Several
vegetable crops that will grow nearby,
including onions and cabbage, will be
picked by hand to ensure that no corn
seeds are mixed with them.
Two trade groups representing companies
that process and ship grain - the National
Grain and Feed Association and the North
American Export Grain Association -
told the USDA they were pleased the
Texas farm is "far removed from
major corn producing areas."
But Gregory Jaffe, who follows the
biotech industry for the Center for
Science in the Public Interest, a consumer
advocacy group, said the USDA released
insufficient information about the site
to judge whether the crop was a threat.
He also shares the food industry's
concern about ProdiGene's plans.
"We should not engineer any food
crop and allow it to be grown on a commercial
scale without FDA determining that that
crop is safe if it gets into the food
supply," he said.
The USDA is taking public comment on
the environmental assessments through
Tuesday.
In 2003, the USDA increased isolation
and inspection requirements for pharmaceutical
crops to avoid a repeat of the ProdiGene
incidents.
"We expected it would mean less
pharmaceutical corn is grown in the
Corn Belt," said Cindy Smith, who
oversees biotech regulation for the
USDA. "We leave it up to researchers
to decide where they are going to grow."
August 5
Honolulu Advertiser
The federal government must reveal
where companies grow genetically modified
pharmaceutical crops in Hawai'i, a judge
ruled yesterday.
Public interest groups are seeking
the information to force the government
to study the environmental impact of
the crops they see as potentially dangerous.
The government and industry contend
public disclosure could lead to crop
vandalism and corporate espionage of
trade secrets.
After weighing the arguments, U.S.
District Judge David Ezra ordered the
U.S. Department of Agriculture to identify
where four companies have received permits
for open-field testing of pharmaceutical
crops in Hawai'i and to reveal the locations
to the environmental watchdog group
Earthjustice and the Center for Food
Safety, a nonprofit that challenges
food production technologies.
"It's definitely a victory,"
said Isaac Moriwake, an attorney for
Earthjustice. "It's basically an
affirmation that the defendants haven't
been able to show that this kind of
information is confidential."
Ezra gave the USDA another 90 days
to prove that releasing the locations
to the public would cause irreparable
damage to the biotech industry. That
step could force biotech companies to
look elsewhere to conduct their pharmaceutical
crop tests, a biotech industry representative
said yesterday.
"It's disappointing," said
Lisa Dry, a spokeswoman for the Biotechnology
Industry Organization. If crop locations
were made public, it would be "a
real detriment for continuing to do
business in that area. Basically it
would be viewed as an unfriendly business
environment for technology of any sort."
Earthjustice sought the locations of
so-called biopharms to force the USDA
to conduct environmental impact statements
before allowing open-field crop research.
Biopharming is a relatively new area
of research where plants are engineered
to produce nonfood items, such as drugs
or industrial chemicals. Without confirmation
of the locations, Earthjustice would
have difficulty making the case for
an environmental impact statement.
Ezra said yesterday that the locations
of such tests don't constitute confidential
business information. He also said the
government and the Biotechnology Industry
Organization failed to provide sufficient
evidence that such crops would be damaged
if their locations were revealed.
Representatives for both sides of the
issue said this would be the first time
in the United States that locations
of biopharm tests would be revealed
to an outside party. That could set
a precedent for similar disclosures
in other states and could pave the way
for disclosing the locations of all
genetically modified crop research.
In Hawai'i, Monsanto Co., the Hawaii
Agriculture Research Center, ProdiGene
Inc. and Garst Seed Co. have been granted
permits to test biopharm crops. Under
Ezra's order, the locations of the testing
will be disclosed to Earthjustice, but
they must keep the information confidential
for at least 90 days.
Environmental groups and food processors
contend that open-field testing of biopharm
crops is racing ahead of what is known
about potential risks to the environment,
people and the food supply. Industry
officials contend that government regulations
sufficiently minimize such risks.
Dry said research into using plants
to produce drugs or industrial chemicals
holds promise for producing compounds
cheaper and faster than in factories.
The seed-crop industry employs an estimated
1,190 people in Hawai'i in relatively
high-wage jobs. In the past decade,
the value of the state's seed-crop industry,
40 percent of which is estimated to
involve genetically engineered crops,
has grown fivefold, to a record $50.5
million. The amount spent on biopharm
crop tests is unknown, but represents
a small fraction of the industry in
Hawai'i.
Hawai'i leads all states in open-air
test sites of genetically engineered
crops.
Michael Rodemeyer, executive director
for the independent Pew Initiative on
Food and Biotechnology, said there are
strong arguments on both sides of the
disclosure issue.
"Certainly there are ways to make
more information available to consumers,"
he said. "It's not clear that crop
location information is really going
to help people understand more about
what these safety issues are.
"It may give them a greater sense
of confidence, but that has to in turn
be weighed against the potential that
these crops could end up being destroyed
which may end up spreading some of these
crops around."
