Construction work at Cambrex Corporation's Charles City site in Iowa (US) has been completed. The global CDMO invested US$24 million in the new highly potent API (HPAPI) manufacturing facility.
Cambrex said the 6,000 sqft facility is currently undergoing validation and will be ready to commence customer projects in May 2019.
The production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m3. Infrastructure includes four reactors ranging from 200 to 1,000-gallon capacity enabling manufacturing campaigns of batch sizes up to 300 kg.
With the completion of this new facility, the Charles City site now has the flexibility to support all phases of development and offer all scales of HPAPI manufacture across the full OEL band spectrum.
“Across our sites, Cambrex has a strong reputation in the handling and supply of potent molecules, and this investment allows us to increase the capacity we can offer our customers,” commented John Andrews, VP, Operations & Site Director, Cambrex Charles City.
Andrews continued: "We have seen an increased number of molecules in the clinical pipeline being designated as potent and highly potent, so having the flexibility within our manufacturing network to scale up with existing customers as projects progress, as well as accommodate new projects, is crucial to meet those market needs.”
Cambrex’s Charles City, Iowa facility employs over 370 people and is located on a 45-acre site. The site is part of the company’s Drug Substance business unit and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.