Minakem Plans Opening of High-Containment API Mfg FacilityBy
Minakem, the contract development and manufacturing division of Minafin, a Mont-Saint-Guibert, Belgium-based fine chemicals producer, plans to open a new closed-controlled environment high-containment production facility in August 2018 at the company’s plant in Louvain-la-Neuve, Belgium.
The new facility extends Minakem’s capacity to develop and manufacture highly potent active pharmaceutical ingredients (HPAPI) compounds, such as antibody-drug conjugates (ADC) from small-scale development to full GMP batch releases. Minakem’s facility will be equipped with a preparative chromatography system that allows the isolation and purification of target molecules at varying scales, from milligrams to hundreds of grams. Minakem’s HPAPI production is expected to be carried out with an occupational exposure limit below 0.1 μg/cubic meter/8 h.
The new facility has nine fume hoods and a double-barrier of protection in the form of glove boxes in room dedicated to dry-powder handling and weighing, air locks, HEPA air filters, and cascading flow.
Minakem will start operations in the new high-containment facility in September 2018.