CMLE OKed to start commercial API production at Netherlands plant

By Gareth Macdonald

- Last updated on GMT

Related tags: Clostridium difficile

Cambridge Major Laboratories Europe (CMLE) is set to start commercial API manufacturing at its facility in the Netherlands after approval by Dutch regulators.

The Weert plant passed a pre-approval inspection by the Inspectie voor de Gezondheidszorg (IGZ) in August and, according CMLE business development director Roger, will begin low-volume production of an active pharmaceutical ingredient (API), details of which are being kept confidential.

McDonald told in-Pharmatechnologist.com that CMLE had worked to expand the 12,500m2 manufacturing plant’s capabilities since acquiring it in 2007​ when it bought Dutch chemistry services firm Chemshop.

The site used to focus on the production of developmental APIs for Phase I and II​,” he said, adding that the expansion into commercial manufacturing was borne out of CML’s desire “to stay with projects if the drugs in question made it to market​.”

He went on to explain that after “some disappointments on projects for drug candidates that didn’t reach the market,​” the current clients’ product looks set to gain regulatory approval and there secure CMLE long term manufacturing work.

The Weert facility will continue to produce APIs for trials and provide chemistry services, with the most recent publically announced contract being a synthesis contract with Summit Corp for a preclinical-stage antibiotic drug candidate for the treatment for Clostridium difficile​ infection.

The approval follows just a few months after CMLE’s US parent, Cambridge Major Labs, gained US Food and Drug Administration (FDA) clearance to start large-scale API manufacturing at its facility in Germantown, Wisconsin.

The US clearance was also intended to support a manufacturing contract for a commercial drug product, although again details of the drug in question are being kept confidential.

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