New state-of-the-art cGMP production facility enhances API production capacity
Cambrex has initiated the second significant expansion of its Charles City (Iowa, US) facility in less than three years.
Continuing strong growth in demand for the company's active pharmaceutical ingredient (API) contract manufacturing capabilities is driving the need for more capacity. Cambrex expects to invest between US$45m and $50m during 2015, including a state-of-the-art cGMP production facility and related supporting infrastructure.
This project is expected to be completed in early 2016 and is designed to allow Cambrex to expand further quickly and efficiently its cGMP capacity as future growth requires.
The new manufacturing facility will initially add a total of 70m3 of glass-lined and hastelloy reactors, ranging in size from 7–16m3 along with 6m2 of hastelloy filter dryers to provide a flexible, multipurpose configuration.
The facility will be designed to the highest regulatory and safety standards, capable of handling potent APIs at an OEL down to 1µg/m3 and will significantly increase the company's cGMP manufacturing capabilities. The facility is also expandable with the ability to add additional capacity on a short timeline. The capacity is being added along with 45,000ft2 of new fully cGMP, temperature and humidity controlled warehouse space.
'We are pleased to be expanding again so quickly in this competitive global pharmaceutical landscape,' said Joe Nettleton, VP of Operations of Cambrex Charles City. 'The need for increased API capacity comes on the back of strong market demand and high capacity utilisation of our current large-scale assets. There is high demand for US-based suppliers with large-scale cGMP contract manufacturing capacity and world-class quality systems, and we have demonstrated that we are quite capable of meeting that demand.'
Shawn Cavanagh, Chief Operating Officer of Cambrex, agreed: 'In recent years, we have seen significantly stronger demand for the assets and capabilities that our Charles City facility has. We believe this expansion, combined with a very talented and experienced team, provides an ongoing foundation for our customers' small molecule product manufacturing needs and supports our goal of bringing our customers' products to market quickly.'