Minakem, the contract development and manufacturing organisation (CDMO) division of Minafin, has revealed it is in the final qualification run to open a new closed-controlled environment high containment production facility in August.
Opening
The new facility will be based in the Louvain-la-Neuve plant in Belgium and will extend the company’s capacity to develop and manufacture high potency active pharmaceutical ingredients (HPAPIs) compounds, such as antibody drug conjugate (ADC) toxins, from small-scale development to full GMP batch releases.
Equipped with a preparative chromatography system, allowing the isolation and purification of target molecules at varying scales, from milligrams to hundreds of grams, makes the facility unique in the sector, reports the company.
“This new facility is a significant asset, strengthening Minakem’s position as a leader in developing and producing substantial quantities of highly potent compounds more robustly, safely and economically,” said Amadeo Ferreira, R&D manager at Minakem. “The Louvain-la-Neuve site has handled highly potent molecules for decades. Specialised training, adequacy of housekeeping measures and engineering controls are the pillars in the effectiveness of containment. This new investment allows an increased capacity to integrate new projects as well as handle the most highly potent molecules on the market. These measures are requested by our customers for use in Antibody Drug Conjugates at 10 ng/m3 levels. The entire team is proud to be part of the future generation of drugs aimed at treating cancers.”
The new facility has been designed using the company’s own expertise as well as customer and equipment supplier input. Operations are expected to start in September 2018.