Manufacturing of Highly Potent APIs with Best-Practice Safety and Containment Control Procedures

Highly potent APIs are pharmacologically active substances that exhibit biologic activity at extremely low concentrations, such as a daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of <10 μg/m3 as an eight hour time-weighted average. Approximately one quarter of all new chemical entities and around half of those in clinical development are estimated to be highly potent, with the overall global market for HPAPI expected to increase from $16.5 billion in 2017 to $26.8 billion in 2023 at a CAGR of 8.7%.

It is a key regulatory and safety requirement that prospective hazards associated during the handling of HPAPIs are identified and understood to enable the development of Occupational Exposure Limits (OEL). Together with other factors including Short-Term Exposure Limits (STELs) and the physical properties of an API, the definition of an OEL plus associated health risk classifications enable organizations to conduct risk assessments for operators working in HPAPI facilities. These risks can include various acute, allergenic, corrosive, carcinogenic, mutagenic, toxic, reproductive, and other occupational health hazards.

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