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First Drug from Genetically Engineered Animals Approved
GTC Biotherapeutics got the Food and Drug Administration to
approve its anti-blood clotting drug, Atryn. 
The drug is derived from the milk produced by its
herd of 200 genetically engineered goats. As the International
Herald Tribune explains:
To make its protein, GTC took the human gene for antithrombin and linked it to goat DNA that normally controls production of a protein found in milk. That insured that the antithrombin would be produced only in the milk.
The gene was injected into a one-celled goat embryo, which was then implanted into the womb of a surrogate mother. If it were doing it today, GTC would implant the gene into a skin cell of a desired animal and then produce a clone, a more reliable technique. But Dolly the sheep, the first cloned mammal, had not been created when GTC started its work in the early 1990s.
Once GTC had produced a goat with the human gene that produced the antithrombin in its milk, that "founder" animal was mated with others through conventional breeding to start producing a herd.
Why use goats and other animals to make therapeutic proteins?
Many of the newer protein-based drugs, such as the cancer drugs Avastin and Erbitux and the arthritis drugs Enbrel and Humira, are produced in genetically engineered Chinese hamster ovary cells that are grown in big stainless-steel vats.
But a cell culture factory can cost hundreds of millions of dollars to build. Using livestock eliminates all that steel and shrinks the investment to tens of millions of dollars, said Geoffrey Cox, chief executive of GTC.
One drawback is that given the generation and gestation times of animals, it can take 18 months to start getting protein production from a goat, compared with a few months for cell culture.
Of course, not everyone is happy that goats are exploited in this manner:
"It is a mechanistic use of animals that seems to perpetuate the notion of their being merely tools for human use rather than sentient creatures," the Humane Society of the United States says in its position paper on the practice.
Whole IHT article here.
|2.9.09 @ 11:11AM|#
Was the R&D performed by goats, too, or do they just operate the production line?
|2.9.09 @ 11:15AM|#
A juicy steak, however, says no such thing.
Seriously people, pick your battles.
Reinmoose|2.9.09 @ 11:18AM|#
Instead of taking a pill, couldn't we just eat some
chèvre?
Best... prescription... ever.
Chèvre sec, however, would be preferred.
|2.9.09 @ 11:23AM|#
Goat milk butter is fantastic as well.
I think more drugs should be in food. Why can't a steak come
pre-loaded with a statin? Our salt be loaded with blood pressure
medication?
"Leave me alone, woman. I have to eat this pie to get my
insulin!"
|2.9.09 @ 11:28AM|#
Goats have evil, demon eyes, but they taste pretty good. When I was a kid I had some freshly milked unpasteurized goat milk one time. Awesome.
Taktix®|2.9.09 @ 11:34AM|#
Heads up...
Don't be fooled by the "Humane Society of the United States" name,
as it a different organiation at the Humane Society.
The latter is the animal shelter people, the former is a nutjob
animal-rights group akin to PETA...
|2.9.09 @ 11:54AM|#
I was wondering about that, Taktix, surprised that someone from
the Humane Society would say that.
Second Episiarch on goat meat. Sort of like beef, but milder, and
less stringy.
|2.9.09 @ 11:57AM|#
How does this affect their IP rights? I assume this is a more
secure IP model as the process requires access to a unique
resource.
I understand for example that the generic availability of certain
cancer drugs derived from genetically modified bacteria is
imperiled by the argument that current laws do not apply to the
products of genetically modified organisms.
Neu Mejican|2.9.09 @ 12:12PM|#
Jparker,
This doesn't seem to be an IP issue.
Someone could breed their own goats to get the protein, but I don't
see this being special in any unique way when compared to
manufacturing a drug using more conventional methods.
And if someone stole one of their goats, you have a straight up
theft charge, not IP.
No?
Neu Mejican|2.9.09 @ 12:17PM|#
Jparker,
I mean, don't current IP laws cover a drug derived from natural
ingredients?
You take natural resource X and use your process to get product
Y...patent covers product Y for Z years. This doesn't seem any
different. You take your natural resource X=goats, apply your
process Y=genetically engineer them to produce protein that is then
used in process to make drug.
Warty|2.9.09 @ 12:17PM|#
Do these goats faint?
Third on goats being delicious. When I have a house, I think I'll
keep some goats to 1) mow my grass 2) become food 3) annoy my
neighbors.
Elemenope|2.9.09 @ 12:28PM|#
I think more drugs should be in food. Why can't a steak come
pre-loaded with a statin? Our salt be loaded with blood pressure
medication?
Because most drugs *uniformly taste like ass*. It would ruin said
food. Not to mention that most drugs would not survive the cooking
process intact.
Taktix®|2.9.09 @ 12:29PM|#
When I have a house, I think I'll keep some goats to 1) mow
my grass 2) become food 3) annoy my neighbors.
Come on Warty, we all know the real reason you want the
goats around...
|2.9.09 @ 12:50PM|#
NutraSweet, don't worry. Lack of vision by people like LMNOP will merely lead us to glanding faster. Right now, I could use some calm with this bailout shit.
|2.9.09 @ 12:51PM|#
Many of the newer protein-based drugs, such as the cancer
drugs Avastin and Erbitux and the arthritis drugs Enbrel and
Humira, are produced in genetically engineered Chinese hamster
ovary cells that are grown in big stainless-steel vats.
But a cell culture factory can cost hundreds of millions of dollars
to build. Using livestock eliminates all that steel and shrinks the
investment to tens of millions of dollars, said Geoffrey Cox, chief
executive of GTC.
Plus you can eat them when they are no longer productive milk
producers.
This is all good.
Ska|2.9.09 @ 12:56PM|#
I am also a fan of goat. Sort of a leaner lamb. My brother and I spit-roasted a whole goat 2 summers ago for our annual bbq, and served it with a yellow curry sauce. One of the best things we've ever cheffed up.
Joshua Holmes|2.9.09 @ 12:59PM|#
Oh yeah, this looks like a great idea. And then someone genetically modifies a bull to produce teeth whitener, but instead it grows to 20 feet tall and chases you through a labyrinth with a giant axe. Then you're all going to look like assholes.
|2.9.09 @ 1:03PM|#
@Neu Mejican:
When biologics are approved the production method is fixed circa
phase III trials and is a major part of the approval process. In
order to get approval to market the drug produced from a goat
another party would have to go through the clinical trial process
again. Presumedly the molecule as produced by these beasts
would be recognised as patent worthy and would be protected this
way too.
Disclosure: I am not a lawyer, I am an engineer.
Zeb|2.9.09 @ 1:05PM|#
Couldn't livestock be sentient creatures and tools for human use at the same time?
Elemenope|2.9.09 @ 1:08PM|#
Couldn't livestock be sentient creatures and tools for human
use at the same time?
Yep. What parent hasn't told their kids to mow the lawn, wash the
dishes, or pick up groceries?
I think we can assume that kids are at least as sentient at the
average goat.
|2.9.09 @ 1:09PM|#
Slightly off topic question time:
In Nature Biotechnology this month biotech VC's are
sh*tting their pants over the prospect of capital gains tax being
raised to 20% from 15%. Is this a realistic prospect? (The tax
hike, not the pants sh*tting.)
|2.9.09 @ 1:15PM|#
And then someone genetically modifies a bull to produce
teeth whitener, but instead it grows to 20 feet tall and chases you
through a labyrinth with a giant axe.
"The only thing bull semen has ever done for me is activate my gag
reflex."
Elemenope|2.9.09 @ 1:26PM|#
In Nature Biotechnology this month biotech VC's are sh*tting
their pants over the prospect of capital gains tax being raised to
20% from 15%. Is this a realistic prospect?
A hike to Reagan-era rates? Oh noes!
Elemenope|2.9.09 @ 1:30PM|#
All I want is a cancer-free cig. When does that
happen?
When you switch over to marijuana.
cuernimus|2.9.09 @ 1:36PM|#
I can confirm the expense of cell culture factory based medications. Humira costs ~$2000-$3000 per injection and some people take 1 a week. One would assume the cost would be greatly reduced, especially if clinical trials could begin before the entire herd has been bred.
JB|2.9.09 @ 1:43PM|#
Hopefully they will keep these goats contained. Not to mention the monkeys the military is trying really crazy shit on; I'd prefer 12 Monkeys stay fiction.
|2.9.09 @ 1:46PM|#
...but instead it grows to 20 feet tall and chases you
through a labyrinth with a giant axe. Then you're all going to look
like assholes.
I'm telling you, the pigoons cannot grow tusks!
John|2.9.09 @ 1:50PM|#
I grew up about 2 miles from the "high-security farm in central
Massachusetts", the place was a dumpy little crap farm until these
folks bought it, and they turned it into quite an awesome little
facility. Neither me nor my parents who still live nearby are
concerned about any EEEVIL biotech stuff getting in our water or
air or food supply or whatever. This is a great thing for mankind,
and it was an excellent boost to the two towns that this farm
straddles. If anyone is interested, the facility is here:
http://maps.google.com/maps?f=d&source=s_d&saddr=Charlton,+Massachusetts&daddr=Unknown+road&hl=en&geocode=FUILgwId7by1-w%3BFWqxgwIdl4-1-w&mra=mr&mrcr=0&sll=42.184904,-71.988044&sspn=0.007711,0.013819&ie=UTF8&t=h&z=16
deluded1|2.9.09 @ 3:48PM|#
In addition, one goat will produce about 12 kgs of anti-TNF
blocker in 2 weeks, whereas you'd need 10 1000 L bioreactors
running to produce that in the same time period (with continious
perfusion, anyway). And each bioreactor costs about 1.2 mil to
startup, and only lasts 35-60 days...you'd see a significant price
drop on new bio drugs within about 10 years.
Unless we went to socialized medicine, which would basically
destroy R&D.
Testicular Cancer|2.9.09 @ 4:13PM|#
Elemenope | February 9, 2009, 1:30pm | #
All I want is a cancer-free cig. When does that happen?
When you switch over to marijuana.
http://www.sciencedaily.com/releases/2009/02/090209075631.htm
|2.10.09 @ 12:06AM|#
Episiarch,
Glanding Faster is one of my favorite Welsh melodramas. Shoulda won
an Oscar that year.
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