Replies to post #4033 on GTC Biotherapeutics (fka GTCB)

[floblu14]

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!)

http://www.investorshub.com/boards/read_msg.asp?message_id=12573463

[DewDiligence]

Here’s another story apropos to the supply limitations
of plasma-derived drugs. Please see #msg-20966607
for additional references.

http://news.yahoo.com/s/nm/20070814/hl_nm/blood_donor_dc_1

>>
Size of Blood Donor Pool Has Been Overestimated

SOURCE: Transfusion, July 2007
14-Aug-2007

The number of people in the United States who are available to donate blood is considerably overestimated, according to a new study.

The current method of estimating the pool of eligible blood donors uses age as the only criterion for excluding people from donating blood. In reality, a number of other factors can lead to ineligibility and "the full impact of donor exclusions on the eligible donor pool has not been fully investigated," note Dr. Jeffrey McCullough and colleagues in the journal Transfusion.

McCullough's team at the University of Minnesota in Minneapolis created a model to help estimate the number of people in the U.S. who are not eligible for blood donation. The model incorporated a number of exclusionary factors, including high-risk behavior and certain chronic diseases.

The authors note that in 2003, the U.S. population was approximately 294 million. Conventional methods would suggest that there would be 178 million eligible donors. Based on their model, however, McCullough's team calculates that only 111 million persons were eligible.

Therefore, the conventional method overestimates the national pool of eligible individuals to donate blood by 59 percent.
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