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"Developing and Manufacturing Drugs with HPAPIs"

Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient.

Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. The level of containment necessary for a potent drug product is not just limited to potent or non-potent classification. The degree of potency and specific risks will determine the level of containment needed to ensure operator safety and prevent cross contamination at the development and manufacturing facility. This article discusses how to effectively classify highly potent APIs (HPAPIs), and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient.

• Understand how to identify and classify potent and highly potent compounds
• Gain insight into the critical steps needed for introducing new HPAPI products to a facility
• Learn about the important containment considerations for handling HPAPIs

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