US-based innovative life sciences company Cambrex Corporation completed a major expansion of its active pharmaceutical ingredient (API) facility in Charles City, Iowa, US, on 12 July 2016. 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 3 expansion project has added production and warehouse facilities to the existing plant, as well as increased the production capabilities of the facility to meet the growing demand for Cambrex’s APIs.
Initiated in February 2015, the project is the second significant expansion of the Charles City facility undertaken by Cambrex since its acquisition in 1991. The expansion also laid the groundwork for another expansion called Pharma 4, which Cambrex plans to undertake during 2017-2018.
The Charles City facility is spread over a 45-acre site in North Central Iowa, and produces a range of APIs and intermediates for pharmaceutical and biotech industries. Cambrex has invested more than $125m in the facility since 1991, to meet the growing demand and also to expand its product portfolio of small molecule and APIs.
The facility consists of three large-scale commercial cGMP manufacturing facilities, pilot plant facilities with different materials of construction, high-potency development centre for ECB 4 chemical development, research and development (R&D) labs, warehouse, and analytical labs.
Equipment installed at the facility include 300gal and 100gal glass lined reactors, 300gal stainless-steel reactor, 100gal Hastelloy reactor and cGMP Kilo labs.
In addition, the facility 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 of 94,000gal capacity, ten centrifuges, ten dryers, thin film evaporators, water injection system, and wastewater treatment unit.
Cambrex added a 7,000ft² (650m²) temperature-controlled facility in 2013 to increase API manufacturing capabilities. The expansion added 40,000gal of reactor capacity to the plant.
The Pharma 3 project added a 7,500ft² 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 to 16m³ in size.
The hastelloy reactors will facilitate the handling of APIs at an occupational exposure limit (OEL) of down to 1µg/m³. The facility is also equipped with 6m² 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 2-8oC 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.
The Pharma 3 project added a 7,500ft² (696.6m²) manufacturing shell to the Charles City facility as part of another planned expansion called Pharma 4. 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 3 project will reduce the lead time in bringing the new facility online.
Based on the capacity utilisation of the Pharma 3 project, the timelines for the Pharma 4 project will be decided by the end of 2016 or early-2017.
Dean Snyder Constructions was contracted to provide construction services for the project.
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