Highly Potent Active Ingredients

Bachem has acquired considerable experience in the GMP production of highly potent active ingredients (HPAPIs) and cytotoxics.

HPAPIs are produced in a dedicated facility. Its design is based on the concept of high containment to ensure an occupational exposure limit (OEL) below 0.1 µg/m3/8h (class 3 according to SafeBridge Consultants Inc). Moreover, a cascade of downward pressures throughout the facility collects and filters all airborne particles.

The various suites are isolated, each with separate access points. Consequently, projects are carried out according to the strictest safety guidelines as to protect the personnel, the environment and certainly the product. This facility design also prevents any cross-contamination by other active ingredients. The HPAPI unit is also equipped with the required chromatographs and freeze-driers for purification and isolation of complex organic compounds such as natural products or peptides.

Typically, HPAPIs such as cytotoxic actives are handled in batch sizes ranging from grams to multi-kg. The custom product development includes all the required QC support, from the first synthesis to large-scale production. We also conjugate the active small organic molecules to peptides or carriers if desired. Conjugation reactions are a specialty of Bachem.

Bachem is continually planning the required new capacities for future demand.