Manufacturer of small molecule innovator and generic active pharmaceutical ingredients (APIs), Cambrex, has announced the completion of its pilot plant expansion at its High Point facility in North Carolina.
High Point
The expansion comprised the installation and commissioning of a fourth reactor suite, which includes two 2,000 L glass lined reactors and a 0.6 sq. m Hastelloy C22 filter dryer. Overall, the new suite increases the site’s reactor capacity by 30% and enables the manufacture of batch sizes typically 10–100 kg under cGMP conditions for clinical phase projects.
Additionally, the High Point site has completed and implemented an upgrade of its analytical chromatography data systems for QC and analytical R&D to Empower 3 software, which enables enhanced capability, integrity and compliance to the site’s analytical systems in line with the demands of regulatory bodies, such as the FDA and EMA.
Furthermore, the company has reported that structural steelwork and foundations are in place for a new $24 million facility at its Charles City, Iowa plant — for the manufacture of highly potent APIs (HPAPIs). This 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. “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.”