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Potent Product Manufacturing in a Multi-Product Facility

Summary: Highly potent drugs are becoming increasingly common in the drug development pipeline. The focus on oncology, rare diseases, and targeted therapies is growing even more acute. While highly potent compounds have benefits in treating many medical conditions, companies with promising highly potent active pharmaceutical ingredients (HPAPIs) can face significant challenges when it comes to using them in development and manufacture. Key challenges in bringing them to market include ensuring that workers and the environment are protected from exposure, and, in a multi-product facility, delivering adequate, compliant controls to mitigate the risk of cross contamination. From assessing potency, assigning risk, and configuring containment and processes, this article explores the key considerations necessary to create a safe and efficient space for HPAPI manufacturing in a multi-product facility.

This article has been published in Volume 15 Issue 2 of IPI:

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