GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>No amount of clinical evidence can refute such a claim [of immunogenicity]<

True, in theory. On the other hand, no antibodies to ATryn have ever been detected in the many patients and volunteers who have been subjected to it during the past 10+ years. If ATryn were immunogenic to a clinically meaningful degree, you would think that some evidence of such would have been seen by now.

Nor is there any reason why ATryn should be immunogenic. In general, immunogenicity of a biopharmaceutical stems from one of two sources: i) the drug’s being a new chemical entity; or ii) impurities in the manufacturing.

On the first point, ATryn is simply human antithrombin; on the second point, GTC’s manufacturing process is exceptionally pure: the impurities are at or below the level of detection of the assays.



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