A significant proportion of new drugs under development contain high-potency active pharmaceutical ingredients (HPAPIs), which is leading to explosive growth in demand for their production. The cytotoxicity of HPAPIs, however, presents handling challenges and requires heavy investment in specialized containment to ensure that employees and their environment are protected from exposure. This article examines the planning, equipment, and facility design of chemical and biologic HPAPIs as well as biologic–HPAPI conjugate manufacture. It also outlines the efforts made by the pharmaceutical industry to develop voluntary standards for HPAPI production and handling.
Five years ago the drivers for containment was almost strictly for protecting the operators for exposure of the compound, equally important, appreciation of containing the product so the risk of cross contamination in the facility. This Masterclass will assess how to improve understanding on containment and identifying how to minimise the risks of exposure.
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