Cambrex Corporation, the leading manufacturer of small molecule innovator and generic active pharmaceutical ingredients (APIs), has announced that it is to invest $24 million in a new facility to manufacture highly potent APIs (HPAPIs) at its Charles City (Iowa, USA) plant.
The 4500 sq. ft 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 be made up from 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 providing a single high containment building to support early stage development and manufacturing, providing flexibility across a broad range of scale. Construction and installation of all new equipment is expected to be completed by Q1 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 specialised handling due to potency and toxicity,” commented Shawn Cavanagh, COO of Cambrex.
He added, “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 follows the opening of a $50 million, 7500 sq. ft multipurpose manufacturing facility at Charles City in 2016, which added a total of 70 m3 of manufacturing capacity to the site.
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 DEA to import narcotic raw materials at commercial scale.