$24 million project brings new capabilities to Charles City, Iowa facility.
Small molecule, generic active pharmaceutical ingredient (API) contract manufacturer Cambrex recently went public with its plans to install new, highly-potent API manufacturing capability at its facility in Charles City, Iowa. The $24 million expansion, said Cambrex, is aligned with its commitment to small-molecule drug processing and its strategy to pursue the fast-expanding market for contract services companies with the specialized capacity to manufacture highly potent APIs.
The project adds an environmentally controlled 4,500 sq. ft. production area within the Iowa facility designed to operate to an occupational exposure limit of down to 0.1µg/m3. The new manufacturing area offers a range of reactor sizes with a total capacity of 2200 gallons. Glass and Hastelloy reactors, ranging in size from 200, 500 and 1000 gallons will be installed, able to manufacture batches from 50 to 300 kg by the projected Q1 2019 completion date.
The expansion, stressed Cambrex, is part of its overall growth plans, earmarked by investment across the company’s global manufacturing and development facilities. The Charles City project follows the opening of the company’s $50 million, 7500 sq. ft. manufacturing site at that location in 2016. The primary facility is located on a 45-acre site and is configured to be able to flexibly process APIs, pharmaceutical intermediates and both highly potent and highly controlled substances. According to Cambrex, its facility is authorized by US regulators to import narcotic raw materials at commercial scale.
Reiterating the company’s intentions, Shawn Cavanagh, COO of Cambrex explained “This expansion is in line with Cambrex’s commitment to ongoing investment in small molecule manufacturing, as well as responding to the rising number of APIs that require specialized handling due to potency and toxicity,” adding, “Cambrex has built a strong reputation in the clinical-scale supply of potent, and extremely potent molecules, and the flexibility that this facility will give allows us to effectively handle projects throughout their development and commercial life-cycle.”