Development of Highly Active Pharmaceutical Ingredients (HAPI)
The trend in pharmaceutical industry to develop increasingly potent active pharmaceutical ingredients (HAPI) to address a number of unmet clinical needs has brought the challenge to deal with the more and more severe potential occupational health hazards, requiring the implementation of a range of special containment measures to ensure safe operation through all phases of development & manufacture.
These measures relate to:
- Protection of personnel
- Protection of product
- Protection of the environment
Minakem High Potent site of Mont St Guibert has pioneered from the late 90’s the utilization of containment technology (closed systems) for the production of HAPI. The site has now more than 30 years’ experience in running a variety of chemistry in containment system, implementing controls & cleaning procedures for a safe handling of such materials.
The site offers today a state of the art high containment manufacturing facility and extremely well trained people to handle from early stage development, to scale-up & commercial manufacture high potent API with occupational exposure limits (OEL) down to 0.1 μg/m³/shift (OEB class 5).