Safe processing of highly potent active ingredients (HPAPI)

Highly potent active pharmaceutical ingredients (HPAPIs) are becoming increasingly important in the pharmaceutical industry. They unlock new, promising treatment options, particularly in oncology. At the same time, they pose major challenges for production: Their effectiveness requires careful handling, as even the smallest quantities require extensive containment measures to protect people, the environment, and the purity of the product.

Rapid growth meets high demands

The number of highly effective drugs is growing rapidly. Whether personalized cancer therapies or targeted antibody drug conjugates (ADCs), they are changing therapy from the ground up. Even the smallest quantities are sufficient to achieve an effect. However, if personnel come into uncontrolled contact with these substances, serious health risks can arise. The safety requirements for processing are correspondingly high. A common limit is an OEL value of ≤ 10 µg/m³ - i.e. a maximum concentration in the air that is permitted in the workplace. Such active substances require an extremely high level of control and protective measures.

Why containment is mandatory

Handling HPAPI poses risks, especially for production employees. Likewise, production personnel are one of the biggest sources of product contamination. Modern containment concepts ensure that neither potentially hazardous substances get outside, nor particles or germs get inside.

Processes, systems, regulations - Everything must be compatible

Due to the risks involved, highly potent active ingredients require a production environment in which all components are perfectly coordinated. Devices and systems must be easy and safe to clean to avoid cross-contamination. Transport systems that can be dismantled, automated washing processes, and simulations reduce risks and increase process reliability. This also applies to cleaning the outside of the vials, as safe further processing is only possible without residues.

In addition to the technical challenges, regulatory requirements are also increasing. Manufacturing processes must not only comply with the principles of Good Manufacturing Practice (GMP), but also with environmental, health and safety (EHS) requirements.

All of this emphasizes that safety is not an add-on but must be an integral part of planning. It is not just about minimizing risks, but also about ensuring that product quality and employee safety are always guaranteed.

In the video, the experts demonstrate key points for the safe handling of highly potent active ingredients and how modern production systems must be designed to meet the increased requirements.