Cambrex Completes Pilot-Plant ExpansionBy
Cambrex, an East Rutherford, New Jersey-based contract manufacturer of small-molecule active pharmaceutical ingredients (APIs), has completed a pilot-plant expansion at its facility in High Point, North Carolina with the installation and commissioning of a fourth reactor suite, which increased the site’s reactor capacity by around 30%.
The new 400-square-foot suite includes two 2,000-liter glass-lined reactors and a 0.6-square-meter Hastelloy C22 filter dryer to allow the manufacture of batch sizes of 10 kg to 100 kg under cGMP conditions for clinical-phase projects.
Cambrex also completed and implemented an upgrade of the High Point site’s analytical chromatography data systems for quality control and analytical research and development.
In another development, Cambrex reports that structural steelwork and foundations are now in place for a new $24-million facility for manufacturing highly potent active pharmaceutical ingredients at its site in Charles City, Iowa.
The 4,500-square-foot production area will operate to an occupational exposure limit down to 0.1µg per cubic meter 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.
The project will also see the reconfiguration of the existing small-scale manufacturing area to provide a single high-containment building to support early-stage development and manufacturing. The facility is expected to be operational in the first half of 2019.
Cambrex recently announced that it had also completed the construction and validation of a new 11,000-square-foot analytical laboratory at its High Point facility as well as the installation of multiple continuous flow reactor platforms.