<<In regards to DNA or viral contamination, the bottom line is that the FDA is convinced that it's not a problem for CHO cells. The verdict is still out on GTCB's expression format.
To the 2nd point, I still submit that there is a far, far, far greater concern about heterogeneity and contamination when dealing with a herd of animals than a fermentation culture of CHO cells. Mother Nature is an extremely powerful force and she has ways of wreaking havoc in a manner which you never imagined. However, as I stated before, I believe that GTCB's scientists have overcome this risk, and in this case, it's a good thing, because this risk is the single most important reason that we all have been able to purchase this stock at a very nice discount.>>
First, you don't really think DNA is an issue with either CHO or milk derived proteins, do you?
Second, the opinion of the FDA isn't going to be the same as the uninformed public and there is no reason to think they won't considered a contolled set of animals held in very clean and isolated conditions as being safe. The EMEA has already approved rATIII. I repeat, the EMEA has already approved rATIII. It is now a validated technology. Why do you think the FDA will be so negative?
Third, you are comparing CHO derived proteins to those from goats milk. That isn't a valid comparison for rATIII. You need to compared milk from clean and well isolated goats that derived from pooled human blood taken from a variety of people. Such blood can contain many pathogens and viruses known and unknown. How do you think HIV and Hep atici B and C have spread so widely? There is no comparison and the milk derived proteins are far safer.
