| OBSERVATION'S |
ONE INDICATION that the high-potency industry is growing is recent expansions on the part of contract manufacturers. For example, Co. recently completed a major expansion at its Waukegan, Ill., high-potency unit. The company says it can now offer a full spectrum of quantities, with reactors able to produce 30 kg of product in one batch. |
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| STATUS |
Co. has been certified so far in the SafeBridge program. Co. went outside to SafeBridge because, even though it had 18 years of experience in potent compound manufacture and knew what was needed to make commercial quantities safely, "what we didn't have was a scientifically supportable means to know we were assessing and managing risks properly," Co. asserts that the SafeBridge approach is an emerging industry standard. "There is an absolute need from a liability standpoint, if nothing else, to have a criterion against which business managers and risk managers can measure and scientifically assess whether or not a contract manufacturer is really capable and suitable" to make potent compounds, he says. This need is becoming increasingly important as outsourcing activity grows, he adds. |
| UPDATE | 04.01 |
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