Cambrex Corp. has completed and validated a $50 million production and warehousing expansion at its cGMP Charles City, Iowa site. The investment expands capacity and capabilities for small molecule APIs and large scale assets.
 
The 7,500 sq. ft. multi-purpose manufacturing facility will initially add 70m³ of glass lined and Hastelloy reactors from 7m³ to 16m³, along with 6m² Hastelloy agitated filter dryers for multi-purpose configuration, and will be capable of handling potent APIs at an Occupational Exposure Limit (OEL) of down to 1μg/m³.
 
The 36,000 sq.-ft. 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 appropriate extraction and handling for flammable materials.
 
Additionally, a 7,500 sq.-ft. 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,” commented Steve Klosk, CEO of Cambrex. He added, “We have invested over $125 million 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.”
 
The Charles City facility manufactures a range of APIsand pharmaceutical intermediates, including highly potent molecules and controlled substances, and is authorized by the U.S. DEA to import narcotic raw materials at commercial scale.