Cambrex Corporation has completed and validated a $50-million production and warehousing expansion for active pharmaceutical ingredient (API) manufacturing at its cGMP site in Charles City, Iowa. 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 new 7,500 square-foot multi-purpose manufacturing facility will initially add a total of 70 cubic meters of glass-lined and Hastelloy reactors ranging in size from 7 cubic meters to 16 cubic meters, along with Hastelloy agitated filter dryers for a multi-purpose configuration that will be capable of handling potent APIs at an occupational exposure limit of down to 1μg/cubic meter. The facility complements the three existing large-scale manufacturing facilities at the Charles City site.

The 36,000-square foot 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 further 7,500-square-foot manufacturing shell has been constructed and will be fitted out to customer specification.

Source: Cambrex