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Six Steps to Handle High-Potent Molecules in a Shared Facility

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Six Steps to Handle High-Potent Molecules in a Shared Facility

By Softigel by Procaps

Six Steps to Handle High-Potent Molecules in a Shared Facility

By Softigel by Procaps
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In recent years, the development of highly potent molecules has become more frequent, and around 25% of the components that are being developed are classified as potent. As older products reach patent expiry, generic-drug companies are also moving into this space, increasing the demand for capability and capacity to manufacture highly potent Active Pharmaceutical Ingredients (APIs).

High potent APIs are defined as a pharmacologically API or intermediate with biological activity at approximately 150 µg/kg of body weight or below in humans (therapeutic daily dose at or below 10 mg), with an occupational exposure limit (OEL) at or below 10 µg/m3 of air as an 8-hour time-weighted average.

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