How a growing digital toolbox is enabling pharmaceutical developers to advance high potent API production.
Digital
Authors: Niklaus Künzle, Head, Process Technology & Innovation & Conrad Roten, Group Leader, API Development Services Lonza AG Visp, Switzerland.
Highly potent API (HPAPI) are playing a growing role in the small molecule pipeline due to their usefulness in treating cancer and other indications. As these compounds have a physical and clinical effect at very low dose, they pose potential occupational health risks. Personnel in development and production facilities must be protected at all times from the products they manufacture. The sustainable production of highly potent APIs (HPAPIs) therefore requires specific precautions for operator health and safety on the one hand and for product quality on the other (Fig. 1).