Cambrex Corporation, a manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (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 around 30 percent.
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 10-100 kg under cGMP conditions for clinical phase projects.
The High Point site also has 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.
Cambrex recently announced that it had also completed the construction and validation of a new 11,000-sq-ft analytical laboratory at High Point, as well as completing the installation of multiple continuous flow reactor platforms.
HPAPI Plant Work Continues
Meanwhile, Cambrex also reported that structural steelwork and foundations are now in place for 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 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 U.S. investments will enhance Cambrex’s cGMP capabilities and offer our customers expanded technologies and services,” commented Shawn Cavanagh, COO 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.”
(Source: Cambrex Corporation; pictured Cambrex pilot plant expansion at High Point, NC)
