GTC Biotherapeutics (fka GTCB)

[DB9]

Animals for drugs
January 10, 2009 by Richard
http://pathtosustainable.wordpress.com/2009/01/10/animals-for-drugs/

ROCKVILLE, Maryland (Reuters) - The first drug made using genetically engineered animals to near U.S. approval won key support on Friday from an advisory panel that judged it safe and effective despite concerns from groups worried about the genetic tinkering.

GTC Biotherapeutics Inc’s experimental anticlotting therapy, called Atryn, is made using a human protein gathered from female goats bred to produce it in their milk.

Producing therapeutic drugs in animals rather than in human cell culture or bacteria could have substantial effects on the costs associated with many drugs. The physical plants needed to produce many protein-based drugs are extremely costly. Actual capacity is limited and can take years to build.

In addition, there are difficulties with the cost of manufacture itself (i.e. the specialized media needed to grow the cells) as well as waste disposal problems after the protein has been produced.

Pharming overcome these difficulties with a more sustainable approach. Not only are media costs much less (i.e. potentially actual chicken feed) but the production levels (that is, the amount of protein per volume of ‘media’) can be much greater. This means a herd of 150 goats could produce the world’s supply of a drug, rather than a $100 million manufacturing facility.

Using farm animals hold advantages over using plants. Plant fertilization can be problematic, since pollen is air-borne. It is much easier to monitor the whereabouts of animals than of plants, so it is unlikely that the GM animals will trade genes with other animals. Production animals can be neutered so that no genes will be passed in any unintended fashion. Disposal could proceed much like current drug facilities but the ‘waste’ should be much smaller. Energy costs would be less.

Animals from rabbits to cows can be used. The economic footprint of this approach appears to be much lower than the huge footprint of a 10,000 liter manufacturing plant. In addition, scaleup would be much easier and more quickly performed using animals.

Often new products render a current therapeutic obsolete. Currently, the expensive manufacturing facility must then be modified for a new product or sold to someone who needs the capacity. Mothballing a facility can be very expensive and modifying it can also entail a large cost, which is passed onto us. Not so with animals.

A big plus is that instead of only producing drugs with a billion dollar market, the economies of this approach could make it easier to produce drugs for much smaller markets. Thus a more sustainable approach for the production of therapeutics could be maintained.



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