You will have to excuse some of my misunderstandings since I'm a rookie to this board. Besides that my background is in the physical sciences and not biological sciences. I apologize for the casual reference to bird flu and swine flue. The point I was trying to make is that there is considerable concern in the general public about viruses and or prion diseases being able to acquire genetic material (DNA) to gain the ability to be transferred to humans and be able to replicate within humans.
GTCB is seeking to introduce a novel platform that is ripe with the potential for misunderstanding. As Dew indicated considerable education is necessary before the idea of transgenic animals yielding therapeutic proteins is likely to gain any level of acceptance. The following quote comes from GTC's website:
"The key enabling science for GTC Biotherapeutics (GTC) is the development of human therapeutic proteins in the milk of transgenic animals. Transgenic animals carry genetic information allowing them to express these human therapeutic proteins in their milk. Once they are produced, these recombinant proteins can be efficiently purified from milk for use as therapeutics."
It is the purification process I'd like more information on because I can see that being a paramount concern for EMEA. I give blood a couple times a year and each 6 months or so it seems like the questionaire and medical history get more detailed trying to root out behaviors that could introduce any number of pathogens into the blood supply. I realize we are talking about therapuetic proteins and not necessarily whole blood but some of the purification concerns are the same. Aren't they?
Finally, assuming the EMEA approval comes off without a hitch this month. What is the general prevailing thought about the US approval process. It seems like the current political environment would likely view the use of transgenic animals for the development of therapeutic proteins in much the same light that cloning and stem cell research are viewed. Combine this with the fact that the FDA is unable to address basic issues like what is necessary to demonstrate generic equivalency for biopharm products and it seems like a lengthy US approval process could await GTCB.
I'm not trying to turn this into a political discussion board nor am I trying to tear down any of GTCB's accomplishments. I just think that politics could influence the approval of GTCB's products. I appreciate the level of scientific expertise evident from many of the posters on this board. I'd like to encourage a deeper discussion of what is likely to be a common concern (purification) from the non-biologist/geneticist perspective. This is an area where I need to be better educated on this matter.
Sorry about the long winded post, but I'm only allowed 3 today so I had to pack it in.
Thanks
FL