Cambrex increases APIs manufacturing capacity in the US

By Murielle Gonzalez | Published: 21-May-2018

Pilot plant expansion at the High Point site is complete and work is underway at new US$24 million high potency plant in Iowa

Cambrex Corporation has announced that it has completed a pilot plant expansion at its High Point facility in North Carolina (US) with the installation and commissioning of a fourth reactor suite.

The company announced the investment in May last year. The US-based life sciences company said the equipment would increase the site’s reactor capacity by around 30%.

A leading manufacturer of small molecule innovator and generic active pharmaceutical ingredients (APIs), Cambrex operates six locations globally, including manufacturing facilities in the US and Europe.

The new 400 sq ft suite includes two 2,000 litre glass lined reactors and a 0.6 sq m Hastelloy C22 filter dryer, allowing the manufacture of batch sizes typically 10-100kg 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.

Further investment

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

Announced in August 2007, the project comprises a 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 kg to 300 kg.

Cambrex's Charles City, Iowa plant

Cambrex's Charles City, Iowa plant

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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