Digitalization In HPAPI Development & Manufacturing – Hype Or Valuable Toolbox?

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.

However, while protecting workers is a critically important element of HPAPI production, biopharma innovators need access to many other specialised capabilities to bring their HPAPI innovations from concept to commercialisation. As HPAPI molecules grow in prevalence, the pharma & biotech industry is seeking new ways for efficient and safe development and production methods to meet rising demand [1,2]. A rapidly growing toolbox of digital technologies can be applied in many areas of both process development and production, which may help accelerate improvements in HPAPI production.