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Re: Pre_Clinical post# 4258

Monday, 07/23/2007 6:39:46 PM

Monday, July 23, 2007 6:39:46 PM

Post# of 19309
>Im not barking up wrong the tree, I never once said the Atryn was immunogenic.<

You suggested that GTC’s drug candidates have a greater likelihood of immunogenicity than recombinant drugs produced by other means. There is no evidence I’m aware of to support such a notion.

Further, you ignored the point that GTC can engineer post-translational modifications into its production process should the need arise in a specific instance. This makes the variability of glycosylation close to being a non-issue, IMO, except to the extent that it could have a slight impact on production cost.

If you want a full-fledged match with the glycosylation pattern of an endogenous protein without the need to do post-translational modification, the only way to get it is from plasma. However, plasma-derived drugs have safety concerns that are far more consequential than the issues we’ve been debating, IMO.

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