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Re: DewDiligence post# 4033

Wednesday, 07/04/2007 9:31:44 PM

Wednesday, July 04, 2007 9:31:44 PM

Post# of 19309
In addition, from another one of Dew's post -

FDA officials interviewed for this article agreed, noting many of the safety risks posed by animal bioreactors also arise with other production methods. For instance, therapeutic proteins are made with mouse and yeast cells, and culture media often contain fetal calf serum, providing ample opportunity for exposure to non-human elements. “I don’t see any show stoppers for these kinds of products,” says Basil Golding, director of the division of Hematology at FDA’s Center for Biologics Evaluation and Research. “Provided good manufacturing practices are followed, the products would be approved if the studies met certain requirements of safety and efficacy.” (NO problem for GTC!)

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