permaculture

[Keith Johnson <keithdj@mindspring.com>]

Old MacDonald Had a Drugstore - Eeyai!Eeyai!Oh sh...!



> Farm Goes High Tech With Genetic Research
> Nanny goats, implanted with embryos injected with extra genes, will be able
> to produce drug-laden milk. (Michele McDonald - For The Washington Post)
>
> By Justin Gillis
> Washington Post Staff Writer
> Monday, January 17, 2000; Page A1
>
> FRAMINGHAM, Mass. – On a rustic expanse of woods and fields and barns not 
> far
> from here, a fifth-generation dairy farmer in blue coveralls tends a
> bleating, affectionate herd of goats. The rituals of rural life play out
> every day: Feed the goats. Milk the goats. An 1850 farmhouse, restored to
> splendor, welcomes visitors, and an old buggy trail wends across the land.
> The future, it seems, is going to look a lot like the past.
> But not entirely. Just yards from the barns and the buggy trail, people in
> laboratory coats peer through microscopes while expensive machinery whirs.
> Phrases like "protein expression" and "embryonic microinjection" are thrown
> around as casually as old-time farmers discussed the weather. In the century
> of wonders now dawning, this old dairy farm is likely to be a showplace, an
> exhibition of the possibilities of technology.
> Some of the goats on the farm, run by a company called Genzyme Transgenics
> Corp., have human genes in them. Others have genes not found in nature, 
> genes
> produced by human artifice. In their milk, the nanny goats produce drugs. 
> Old
> MacDonald's farm it isn't: One goat is expected to make drug-laden milk 
> worth
> as much as $30 million a year.
> Genzyme is competing with two companies, including the one that helped 
> create
> Dolly the cloned sheep, to be first to bring to market a drug produced in
> "transgenic" animals. At all three companies, the logistics of producing
> drugs this way have largely been solved – their scientists have repeatedly
> shown it can be done. What remains is to commercialize the technology, known
> as "pharming," and in that goal Genzyme has a jump on its competitors: It is
> farther along than any other company in human testing of a transgenically
> produced drug.
> Last week the firm reported positive test results of the compound, a protein
> believed to aid in preventing blood clots during heart-bypass surgery. It 
> was
> the second major study to suggest the drug works, and a final test is under
> way. If the results hold up, Genzyme could win approval from the Food and
> Drug Administration to sell the drug by sometime next year.
> The anti-clotting drug is just an opening salvo, however. Working with other
> companies that want cheaper, easier ways to make drugs on a large scale,
> Genzyme has produced more than 60 in the milk of mice, an initial test of
> whether the method will work for a given drug. Goats on the farm are making
> 11 drugs at potentially commercial levels.
> As soon as Genzyme has proven drugs produced this way can win regulatory
> approval, it's likely other firms will commit. A dozen drug companies have
> established research collaborations with Genzyme aimed toward commercial
> production.
> "Your drug may soon come from the farm near you," said Sandra Nusinoff
> Lehrman, the company's president and chief executive.
> At a handful of spots around the world, including an old family farm outside
> Blacksburg, Va., the efforts of companies like hers are changing the
> landscape. Cutting-edge science is joining forces with farmers' ancient
> knowledge of the ways of animals. A handful of savvy localities are courting
> these operations, hoping for jobs and a new vitality down on the farm.
> Making Milk Valuable
> Genes are instructions for making proteins, some of them useful as drugs. In
> the late 1970s, at the dawn of the biotechnology era, scientists stuck 
> animal
> and human genes into bacteria and into hamster cells, essentially hijacking
> their cellular machinery to create microscopic drug factories. Human insulin
> for diabetics, human growth hormone for children with dwarfism – these and
> other breakthroughs flowed from the new science. Today, scores of drugs are
> made this way, in individual cells that grow by the trillions in giant,
> high-tech vats called bioreactors.
> But a building full of these reactors can cost $30 million and up. Such
> factories can be tricky to run. And some types of complex proteins can't be
> made efficiently – or at all – in bioreactors.
> Thus in the 1980s, people hit on the idea of sticking human genes into
> animals. One of the first to think of it was Harry M. Meade, a Boston area
> scientist who now works for Genzyme Transgenics. He knew the whole purpose 
> of
> mammary glands is to produce a suspension of proteins, otherwise known as
> milk. Milk glands are, in effect, miniature bioreactors, perfected for
> protein production by millions of years of evolution. They can handle the
> most complex jobs.
> And Meade knew from personal experience that farm animals can make milk in
> vast quantity – he grew up on a dairy farm and still goes back every summer.
> "I don't think I would have thought of this if I hadn't," he said. "My 
> father
> used to say, 'If you want to help the farmer, make milk valuable.'"
> The earliest efforts of researchers like Meade were frustrating. Scientists
> had to isolate the gene encoding a particular protein, then inject it into
> microscopic animal embryos, hoping it would take up residence at an
> appropriate spot in the animal's genetic code. Such challenges helped give
> rise to Dolly the cloned sheep, on the theory that once an animal with the
> proper genetic profile is created, cloning it might be a fast way to produce
> a herd.
> But over many years, techniques improved. At Genzyme, producing an animal
> that can make a drug costs roughly $5 million – much less than building a 
> new
> factory of bioreactors. Once they have a "founder" animal that contains the
> necessary genes, companies like Genzyme can expand rapidly. "If we need to
> scale up, we just breed more animals," said Suzanne Groet, a company 
> manager.
> That is precisely what Genzyme has done to produce anti-thrombin III, a 
> human
> protein that plays a vital role in regulating blood clotting. People about 
> to
> undergo heart bypass surgery need high levels to keep from being killed by
> excessive clots. The drug now is made from donated blood, but is in short
> supply and carries a risk of contamination by viruses. Historically,
> bio-engineered products have tended to drive blood-derived versions off the
> market.
> Nobody has grown human anti-thrombin III efficiently in bioreactors. Genzyme
> has created more than 50 goats that can make it. Their milk is collected and
> put through exhaustive purification steps until nothing is left but the 
> drug.
> So far, Genzyme's tests indicate it works just as well as the protein 
> derived
> from blood.
> "It's very close to becoming real," said Jerrold Levy, director of
> cardiothoracic anesthesiology at the Emory University School of Medicine in
> Atlanta, who has helped to test the Genzyme drug. "This is a wonderful
> opportunity to have an unlimited supply of a protein that has incredibly
> important therapeutic applications."
> Because its uses are so specialized, the drug is not likely to be a
> blockbuster – Genzyme, in fact, deliberately picked off a modest product as
> its test case. S.G. Cowen Securities Corp. recently pegged the worldwide
> market for anti-thrombin III at $200 million.
> Its licensure would prove a point, however, and Genzyme is preparing to
> follow up with a far more ambitious array of proteins. "We are not a
> one-trick pony – or a one-trick goat," Lehrman said. "We have lots of bets 
> on
> the table."
> It's All in the Genes
> Transgenic production is looking more and more, for example, like an ideal
> technique for making a new class of drugs called monoclonal antibodies.
> Antibodies are immune-system proteins that attack foreign invaders like 
> germs
> – or that neutralize substances the body is over-producing. Monoclonal
> antibodies are artificial, highly purified antibodies, made by combining 
> anima
> l and human genetic material, that work with exquisite precision in small
> doses. As treatments, these drugs were a failure for 20 years, but lately
> they have become one of the hottest areas of medicine.
> Centocor Inc. of Malvern, Pa., was the first company to win approval for a
> monoclonal antibody treatment, called ReoPro. It blocks excessive clot
> formation during a procedure doctors use to clear clogged arteries. A second
> Centocor antibody helps sufferers of a severe bowel ailment, Crohn's 
> disease,
> and that same drug, Remicade, has recently been proven to arrest the joint
> damage typical of advanced rheumatoid arthritis. Centocor and dozens of 
> other
> companies are working on new antibodies of similar import.
> Like 11 other companies, Centocor has cut a deal with Genzyme to investigate
> production of its drugs in goats. "We're likely to make a major commitment 
> in
> the next few months," said Fred Bader, vice president of worldwide 
> operations
> at Centocor. "There's no question in my mind they can produce antibodies in
> goats."
> If indeed animals prove their value in such an undertaking, Genzyme will be
> in a commanding position, for the company has won a patent that gives it
> exclusive rights to transgenic antibody production. Barring a successful
> legal attack, the company's competitors, PPL Therapeutics PLC of Edinburgh,
> Scotland, and Pharming N.V. of Leiden, the Netherlands, are likely to be 
> shut
> out of antibody production for years.
> Genzyme Transgenics has appeared lately on Wall Street's radar screen. Its
> stock has risen nearly 160 percent since Nov. 1, closing Friday at $14.87  a
> share. Hambrecht & Quist, a securities firm, told investors recently that
> Genzyme was "uniquely positioned to benefit from the biotechnology 
> industry's
> need for more efficient protein production systems."
> Genzyme Transgenics is an offspring of a group of Boston area companies with
> "genzyme" in their names, but – unlike the others – it is a separate 
> company,
> and a majority of its shares are in public hands.
> As they gear up for commercialization, Genzyme's executives find themselves
> confronting some strange business issues. How, for example, does a corporate
> accountant amortize a goat? Especially one worth millions? "We're blazing 
> new
> trails here with our auditors," said John B. Green Jr., vice president and
> chief financial officer.
> Genzyme is looking to expand beyond goats to cows, which produce more milk
> and are therefore better for drugs or nutrients needed in bulk. It has
> launched a startup program "in Iowa, where cows belong," said Michael W.
> Young, vice president of commercial development. "We have little farms in
> Massachusetts."
> On the Genzyme farm, less than an hour from the company's headquarters in
> Framingham, scrupulous procedures have been set up to ensure the health of
> the goats, many of them imported at high expense from disease-free regions 
> of
> New Zealand. The company has succeeded in cloning three goats, though it
> considers cloning an experimental technique, not one likely to find
> application in producing the first transgenic drugs.
> Locals have welcomed Genzyme, though they certainly found the whole thing 
> odd
> at first. Steve Woodis, a fifth-generation member of a farm family from the
> area, was dismayed by "the state of the dairy industry" and jumped at the
> chance to work at Genzyme when it came to town. Now he's the project's top
> real farmer, a bearded, bespectacled man fond of coveralls and caps and
> schooled his whole life in the ways of animals. He manages a team of farm
> hands.
> "It was a little different at first," he said of working at Genzyme. "I took
> my share of ridicule from my peers. Now they all want to come work here."
> © 2000 The Washington Post Company
>
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