Manufacturing Issues

Manufacturing changes are more like to affect the clinical profile of biological compounds than small chemical entities. Small changes in the three-

dimensional folding, post-translational modification, or glycosylation of proteins can significantly alter biological activity. The potential for the replication of viruses or bacteria in fermenters, and their persistence in finished drug product raise additional safety concerns about the manufacturing process for such compounds. For the clinical trial-ist, this leads to a generality: when studying biolo-gicals, there is usually a greater need for early-stage test medications to be as similar as possible to the marketed product than for 'orthodox' small chemicals.

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