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 facility in Louvain-la-Neuve 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 40 years’ experience in running a variety of chemistry in containment system, implementing controls & cleaning procedures for a safe handling of such materials.
Minakem offers state-of-the-art high containment manufacturing facility and extremely well-trained people to handle from early-stage development to scale-up & commercial manufacture of high potent APIs with occupational exposure limits (OEL) below to 0.1μg/m3/shift (OEB class 6).