Minakem upgrades containment for High Potent API
Minakem has initiated an ambitious investment plan for setting up equipments with the highest level of containment required to develop and produce highly potent molecules such as Antibody-drug conjugates toxins. The investments will enable Minakem to handle High Potent API (HAPI) with an OEL lower than 0.1 µg/m³.8h.
A new laboratory of 130 m² has already been commissioned. It will allow for API development as well as GMP kilolab manufacturing, with appropriate zoning for material and people flows.
The new lab will be equipped with 9 fume hoods, it will boast a fully automated preparative chromatography system for rapid purification of HAPI and Intermediates, and will include dedicated room for dry powder handling and weighing under glove boxes containment.
The new facilities will enable Minakem to support its clients from small-scale development work to full GMP release of lots in a scale between 1 to 100 grams of high potent products with an OEL down to 0.01 µg/m³.8h.