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Re: None

Monday, 06/26/2006 9:44:59 AM

Monday, June 26, 2006 9:44:59 AM

Post# of 251937
Why ATryn?
(from GTCB ymb):

>>
Re: Why ATryn?
by: DewDiligence
06/26/06 04:11 am
Msg: 34158 of 34162

>Why did GTCB choose ATryn for the groundbreaking process of the first transgenic drug approval? In retrospect, was Atryn the best choice?<

ATryn for antithrombin hereditary deficiency was a good choice as a proof-of-principle for GTC’s production technology because: 1) the smallness of the indication allowed GTC to obtain regulatory approval with a small (and relatively inexpensive) clinical trial; and 2) there are no competing recombinant antithrombin products, which enhanced the medical need for ATryn as a safer alternative to plasma-derived AT.

>Is GTCB aiming at the production of dozens of different proteins or just a handful over the next several years?<

I’m not sure how many proteins can fit in a hand (smile ), but dozens of production programs does not sound far-fetched during the next 3-4 years.

>Is their technology, considering the quarantine conditions of the farm, well-suited to the production of high volume proteins (for example, something like epogen), or is it better suited to the ala carte production of niche proteins?<

The suitability of GTC’s technique for a given protein depends largely on the ease of expression of the protein using traditional manufacturing. Apart from this, the larger the expected market for a given protein, the more it makes economic sense to use the cheapest production method in terms of variable costs. Hence, I would argue that the rationale underlying GTC’s platform applies even more strongly to mass-market proteins than to ones for small markets.

>I wonder if GTCB technology might be of some use in the production of monoclonal antibodies?<

Absolutely. GTC has produced Remicade and Tysabri under contract to JNJ and ELN, respectively. Although these programs are no longer active, they demonstrated that GTC’s technology is capable of producing mAbs to the desired purity.

[Posted as a reply to: Msg 34157 by aslan2772]
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