Cambrex Corporation, the leading manufacturer of small molecule innovator and generic active pharmaceutical ingredients (APIs), has announced the completion and validation of a $50 million state-of-the-art production and warehousing expansion at its cGMP Charles City (Iowa, USA) site. The investment in capacity and capabilities was made in reflection of strong market demand for small molecule APIs and high utilization of Cambrex’s existing large-scale assets.
The new 7500 sq. ft multipurpose manufacturing facility will initially add a total of 70 m3 of glass-lined and Hastelloy reactors ranging in size from 7–16 m3, along with 6 m2 Hastelloy agitated filter dryers to provide a flexible, multipurpose configuration, and will be capable of handling potent APIs at an Occupational Exposure Limit (OEL) of down to 1 μg/m3. The facility complements the three existing large scale manufacturing facilities at the Charles City site.
The 36,000 sq. ft cGMP warehouse provides general cGMP storage for 2720 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 further 7500 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 more than $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.”
Cambrex’s Charles City, Iowa 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 authorized by the US DEA to import narcotic raw materials at commercial scale.