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16 May 2018

Cambrex completes pilot plant expansion at its High Point, NC facility

Site's reactor capacity is increased by 30%.

Cambrex has completed a pilot plant expansion at its High Point, NC facility with the installation and commissioning of a fourth reactor suite, increasing the site's reactor capacity by around 30%.

The new 400-sq ft suite includes two 2,000-L glass-lined reactors and a 0.6 m2 Hastelloy C22 filter dryer, allowing the manufacture of batch sizes typically 10-100 kg under cGMP conditions for clinical-phase projects.

The High Point site has also completed and implemented an upgrade of its analytical chromatography data systems for QC and analytical R&D to new, Empower 3 software. Empower brings enhanced capability, integrity and compliance to the site’s analytical systems, in line with the increasingly stringent demands of the FDA and EMA among other agencies.

In a further announcement, Cambrex has reported that structural steelwork and foundations are now in place for a new $24 million facility at its Charles City, Iowa plant, for the manufacture of highly potent APIs (HPAPIs).

The 4,500-sq ft production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m³ and will have a total reactor capacity of 2,200 gallons, consisting of a range of 200, 500 and 1,000 gallon glass and Hastelloy vessels to manufacture batches from 50 to 300 kg.

The project will also see the reconfiguration of the existing small-scale manufacturing area, providing a single high containment building to support early-stage development and manufacturing, providing flexibility across a broad range of scale. The facility is expected to be operational in the first half of 2019.

“Both of these US investments will enhance Cambrex’s cGMP capabilities and offer our customers expanded technologies and services,” commented Shawn Cavanagh, COO of Cambrex. He added: “We will continue to strategically invest across our global network of sites at all scales, from clinical through to commercial, to address customer demands and market requirements.”

Cambrex recently announced that it had also completed the construction and validation of a new 11,000 sq. ft. analytical laboratory at its High Point facility, as well as completing the installation of multiple continuous flow reactor platforms.

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