Cambrex, a US manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), has completed and validated a $50 million state-of-the-art production and warehousing expansion at its cGMP Charles City, Iowa site.
The investment in capacity and capabilities reflects strong market demand for small molecule APIs and high utilisation of Cambrex’s existing large-scale assets, the firm said.
The new 7,500ft2 (around 700m2) multi-purpose manufacturing facility will initially add a total of 70m3 of glass lined and Hastelloy reactors ranging in size from 7m3 to 16m3, along with 6m2 Hastelloy agitated filter dryers to provide a flexible, multi-purpose configuration. The facility will handle potent APIs at an Occupational Exposure Limit (OEL) down to 1μg/m3. The facility complements the three existing large-scale manufacturing facilities at the Charles City site.
The 36,000ft2 (around 3,500m2) cGMP warehouse provides general cGMP storage for 2,720 pallets and segregated 2–8°C refrigerated storage for 360 pallet spaces and features Distributed Control System monitoring and control for temperature and humidity. The facility employs a barcode system for automated bin location and has a dedicated sampling room with extraction and handling for flammable materials.
We have invested more than $125m at the Charles City site since we acquired it in 1991
A further 7,500ft2 (around 700m2) manufacturing shell has been constructed, which will be fitted out to customer specification. 'There is high demand for US based suppliers with large scale cGMP contract manufacturing capacity and world class quality systems,' said Steve Klosk, CEO of Cambrex.
He added: 'We have invested more than $125m at the Charles City site since we acquired it in 1991 and believe that this expansion, combined with a very talented and experienced team, provides an ongoing foundation for our customers’ small molecule product manufacturing needs while supporting our goal of bringing our customers’ products to market quickly.'
Cambrex’s Charles City facility sits on a 45-acre site and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances. The facility is one of a limited number authorised by the US DEA to import narcotic raw materials at commercial scale.
