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Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.
Minakem, the contract development and manufacturing division of Minafin, announced on June 19, 2018 that it is in the final qualification run to open a new, closed-controlled environment, high-containment production facility in August 2018. This high-class production facility is among only a dozen of its kind in the world; roughly half are located in Europe.
The new facility, based at the Louvain-la-Neuve plant in Belgium, extends Minakem’s capacity to develop and manufacture high potency API (HPAPI) compounds, such as antibody drug conjugate (ADC) toxins, 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, geared to addressing a range of needs from routine activity to analytics. Equipment in the facility consists of nine fume hoods and a double-barrier of protection in the form of new generation glove boxes in room that are dedicated to dry powder handling and weighing, air locks, HEPA [high efficiency particulate arresting] air filters, and cascading flow. Minakem’s HPAPI production will be carried out with an occupational exposure limit (OEL) below 0.1 μg/m3/8h.
“The Louvain-la-Neuve site has handled highly potent molecules for decades. Specialized training, adequacy of housekeeping measures, and engineering controls are the pillars in the effectiveness of containment,” said Amadeo Ferreira, R&D manager at Minakem, in the press release. “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 ADCs at 10 ng/m3 levels. The entire team is proud to be part of the future generation of drugs aimed at treating cancers.”
Minakem based the design of the laboratory on its own expertise and input from customers and equipment suppliers. It used a risk analysis approach to define a suitable way to work with highly potent compounds while maintaining great flexibility. It will start operations in the new high-containment facility in September.