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Pastimes : Cutting the Cost of Medicines, realistic approaches

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From: scaram(o)uche6/12/2007 12:58:39 PM
of 2
 
Message 23615876

>> Who needs patent protection when you have batch to batch variability! <<

Really.... for those of us who were putting the first recombinant cell lines into flasks, and assessing post-translational modifications and homogeneity? This entire argument is silly. EVERYBODY was working to reduce heterogeneity. Reality is that the heterogeneity from a flask could be limited to heterogeneity that was also observed on molecules purified from humans, but that it could not be eliminated.

FDA scientists understand this. If cell-based biologics end up being protected due to their inherent variability, it will be politicos that allow such, not FDA bench grunts. IMO.
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