05.15.18
Cambrex Corp., a manufacturer of small molecule innovator and generic APIs, 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 approximately 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 site has also completed and implemented an upgrade of its analytical chromatography data systems for QC and analytical R&D to Empower 3 software, which is designed to enhance capability, integrity and compliance to the site’s analytical systems.
Cambrex also recently completed the construction and validation of a new 11,000 sq.-ft. analytical lab at its High Point facility, as well as the installation of multiple continuous flow reactor platforms.
Separately, Cambrex began construction of a new $24 million facility at its Charles City, IA 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 also includes reconfiguration of the existing small scale manufacturing area, providing a single high containment building to support early stage development and manufacturing. The facility is expected to be operational in 1H19.
“Both of these US investments will enhance Cambrex’s cGMP capabilities and offer our customers expanded technologies and services,” said Shawn Cavanagh, chief operating officer of Cambrex. “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.”
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 site has also completed and implemented an upgrade of its analytical chromatography data systems for QC and analytical R&D to Empower 3 software, which is designed to enhance capability, integrity and compliance to the site’s analytical systems.
Cambrex also recently completed the construction and validation of a new 11,000 sq.-ft. analytical lab at its High Point facility, as well as the installation of multiple continuous flow reactor platforms.
Separately, Cambrex began construction of a new $24 million facility at its Charles City, IA 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 also includes reconfiguration of the existing small scale manufacturing area, providing a single high containment building to support early stage development and manufacturing. The facility is expected to be operational in 1H19.
“Both of these US investments will enhance Cambrex’s cGMP capabilities and offer our customers expanded technologies and services,” said Shawn Cavanagh, chief operating officer of Cambrex. “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.”