Work Underway on New $24M High Potency Plant at Charles City, Iowa
East Rutherford, NJ (GLOBE NEWSWIRE) - Cambrex Corporation (NYSE:CBM), the leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today announced that it 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 liter 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.
In a further announcement, Cambrex has reported that structural steelwork and foundations are now in place for a new $24M 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 300kg.
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.
Cambrex Corporation is an innovative life sciences company that provides products, services and technologies to accelerate the development and commercialization of small molecule therapeutics. The Company offers Active Pharmaceutical Ingredients (APIs), advanced intermediates and enhanced drug delivery products for branded and generic pharmaceuticals. Development and manufacturing capabilities include enzymatic biotransformations, high potency APIs, high energy chemical synthesis, controlled substances and continuous processing. For more information, please visit www.cambrex.com
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SOURCE: Cambrex Corporation