High-containment production facility
In the second half of 2018, France-based pharmaceutical company Minakem opened a high-containment production facility in Louvain-la-Neuve, Belgium.
The facility allows Minakem to economically develop and produce bulk quantities of highly potent compounds. It also extends the company’s capability to manufacture highly potent active pharmaceutical ingredients (APIs) and antibody drug conjugates (ADCs) from small-scale to full-scale good manufacturing practice (GMP) batch releases.
The facility reached the final qualification phase in June 2018. It currently employs 20 scientists and 17 quality check personnel.
Minakem is a contract development and manufacturing organisation (CDMO) division of chemical production company Minafin.
The facility is located in Minakem’s Louvain-la-Neuve site in Belgium, which operates as a separate entity named Minakem High Potent. It is in close proximity to two of Minakem’s existing API sites in Louvain-la-Neuve.
The production facility is equipped with a high-pressure preparative chromatography system that permits target molecules to be isolated and purified at different scales, ranging from milligrams to hundreds of grams.
The plant also features a 130m² laboratory that will engage in the development of GMP kilo-lab manufacturing and is equipped with state-of-the-art equipment, including nine fume hoods, new generation glove bins for dry powder handling and high-efficiency particulate air (HEPA) air filters.
Minakem’s high-performance active pharmaceutical ingredient (HPAPI) production occurs with an occupational exposure limit (OEL) level lower than 0.1µg/m3.8h. The facility also produces antibody-drug conjugate (ADC) toxins at 10ng/m³ levels.
Minakem’s high-containment facility comprises six production lines equipped with stainless steel and hastelloy jacketed reactors varying from 5l to 1,600l in size.
The facility is equipped with different kinds of isolation equipment for batch sizes from 100g to 100kg. They are designed for the safe handling of potent compounds.
The facility’s high-pressure chromatography (HPLC) system includes a 50mm column Hipersep® Prep-HPLC system and 300mm column HPLC system capability. It enables Minakem to manufacture pharmaceutical ingredients that require a high level of purity.
Founded in 2004 and headquartered in France, Minakem is an affiliate of the Minafin Group. It specialises in the manufacture of fine chemicals, API, key intermediates and building blocks for pharmaceutical companies.
Minakem employs more than 450 people at its three facilities in Dunkirk and Beuvry-la-Forêt, France, and Louvain-la-Neuve, Belgium.
The company gained ownership of the Louvain-la-Neuve site by acquiring Belgian company Ajinomoto OmniChem. This acquisition allowed Minakem to expand its pharmaceutical services and fortify the development of its market share.
All the company’s facilities are engaged in producing small, medium and large volumes of complex, regulated intermediates and APIs for the pharmaceutical and life science industries. The facilities are equipped with technologies such as complex multi-step synthesis, halogenation chemistry and steroid chemistry.
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