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To ensure participants' safety, the U.S. Food and Drug Administration (FDA) imposed strict guidelines; products being tested in humans had to be made in facilities certified for, "clinical grade” production.
Since CRP-1 was the company's first product to go into the clinic, Hyperion had no manufacturing facilities which met FDA requirements. It was faced with three options for supplying CRP-1 to the clinic: The first was to build a new 5000 square-foot pilot plant with enough capacity to supply all the CRP-1 needed for Phases I and II of clinical trials. The second option was to contract clinical manufacturing to an outside firm...
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