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Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.
Cambrex Corporation announced in an August 8, 2017 press release that it is to invest $24 million in a new facility to manufacture highly potent APIs (HPAPIs) at its Charles City, Iowa plant. The 4500-ft2 production area will operate to an occupational exposure limit (OEL) down to 0.1 µg/m3 and have a total reactor capacity of 2200 gallons, which will comprise a range of 200, 500, and 1000-gallon glass and Hastelloy vessels to manufacture batches from 50 to 300 kg.
The project will also reconfigure the existing small-scale manufacturing area, creating a single high-containment building to support early stage development and manufacturing and provide flexibility across a broad range of scale. Construction and installation of all new equipment is expected to be completed by the first quarter of 2019.
“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,” said Shawn Cavanagh, COO of Cambrex, in the release. “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 lifecycle.”
This latest expansion is part of an ongoing strategic campaign to invest in small-molecule API development and manufacturing across Cambrex’s global network of facilities, and it follows the opening of a $50 million, 7500-ft2 multi-purpose manufacturing facility at Charles City in 2016.
Cambrex’s Charles City, Iowa facility is located 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 Drug Enforcement Agency to import narcotic raw materials at commercial scale.