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The Key to HPAPI Containment in a Multi-Product Facility

Summary: Drugs containing highly potent active pharmaceutical ingredients (HPAPIs) are becoming increasingly prevalent in the development pipeline due to their benefits in the treatment of various medical conditions, such as cancer and rare diseases. While providing significant benefit, developing and manufacturing these compounds pose several challenges and as a result, a growing number of HPAPI programs are outsourced to contract development and manufacturing organizations (CDMOs) that have the necessary facilities, equipment, and personnel to scale up manufacturing to commercial production, and can share critical infrastructure across multiple programs. This article explores the key factors pharmaceutical companies should consider when selecting a CDMO and evaluating its multi-product facility capable of handling HPAPIs to de-risk their programs and bring their products to patients safely

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