In July 2016, US-based innovative life sciences company Cambrex Corporation completed a major expansion of its active pharmaceutical ingredient (API) facility in Charles City, Iowa.
The Charles City facility is one of the very few facilities in the US to be authorised by the US Drug Enforcement Administration to import narcotic raw materials on a commercial scale.
The $50m Pharma III expansion project has added production and warehouse facilities to the existing plant, as well as increasing its production capabilities to meet the growing demand for Cambrex’s APIs.
Begun in February 2015, the project is the second significant expansion of the Charles City facility to be undertaken by Cambrex since its acquisition in 1991. The expansion also laid the groundwork for another expansion called Pharma IV, which Cambrex plans to carry out from 2017 to 2018.
Cambrex Charles City facility background
The Charles City facility is spread over a 45-acre site in north-central Iowa and produces a range of APIs and intermediates for the pharmaceutical and biotech industries. Since 1991, Cambrex has invested more than $125m in the facility to meet growing demand and expand its small molecule and API product portfolio.
The facility consists of three large-scale commercial current good manufacturing practice (cGMP) manufacturing facilities, pilot plant facilities with different materials of construction, a high-potency development centre for ECB IV chemical development, research and development (R&D) labs, a warehouse and analytical labs.
Equipment installed at the facility includes 300gal and 100gal glass-lined reactors, a 300gal stainless-steel reactor, a 100gal Hastelloy reactor and cGMP Kilo labs.
The facility also includes a high-potency development centre with controlled access, micronisation, drying and packaging units, and analytical and chemical labs. The centre is equipped with 48 reactors with 94,000gal of capacity, ten centrifuges, ten dryers, thin-film evaporators, a water injection system, and a wastewater treatment unit.
In 2013, Cambrex added a 7,000ft² (650m²) temperature-controlled facility to increase the plant’s API manufacturing capabilities. The expansion added 40,000gal of reactor capacity to the plant.
Details of the Pharma III expansion project in Charles City
The Pharma III project added a 7,500ft² (697m²) multi-purpose manufacturing facility with a 17,000ft² (1,579m²) first floor and a 16,000ft² (1,486m²) second floor. The facility is installed with 70m³ of glass-lined hastelloy reactors varying from 7m³ (247ft³) to 16m³ (565ft³) in size.
The hastelloy reactors will facilitate the handling of APIs at a minimum occupational exposure limit (OEL) of 1µg/m³. The facility is also equipped with 6m² (65ft²) hastelloy filter dryers to facilitate multi-purpose centrifugation.
The project also added a new 45,000ft² (4,180m²) pre-engineered Ceco warehouse to accommodate the storage of raw materials and finished products. The warehouse has a storage capacity for 2,720 pallets and segregated 2-8⁰C refrigerated storage for 360 pallets. It is equipped with a state-of-the-art barcode system to facilitate automated bin location.
The cGMP-compliant, temperature and humidity-controlled facility includes a 7,500ft² (696.6m²) dedicated office area and a sampling room for safe extraction and handling of flammable materials.
Pharma IV project details
The Pharma III project added a 7,500ft² (696.6m²) manufacturing shell to the Charles City facility as part of another planned expansion called Pharma IV. The final design of the manufacturing facility and equipment to be installed will be based on customer specifications. Construction of the manufacturing shell as part of the Pharma III project will reduce the lead time in bringing the new facility online.
Based on the capacity utilisation of the Pharma III project, the timelines for the Pharma IV project will be decided by the end of 2016 or early 2017.
Contractors involved with the Charles City facility expansion
Iowa-based construction company Dean Snyder Construction was contracted to provide construction services for the project.