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Cambrex to Establish API CoE


Expands clinical supply and process development at High Point, NC site

Cambrex Corp. is establishing a center of excellence for API clinical supply and process development at its site in High Point, NC. Cambrex will acquire its leased 35,000 sq. ft. facility, as well as an adjacent 45,000 sq. ft. building which will be fitted with kilo-scale and pilot-scale vessels, continuous reaction production, and chemistry, engineering and analytical development labs. 
The center will also focus on the development of new technologies, innovative chemistry and engineering solutions as well as technology transfer to commercial scale.
“The purchase of the High Point site gives us greater control over the future of our North American business to allow us to invest in making this a central hub and leader in clinical supply, process and technology development in the U.S.,” said Steven Klosk, Cambrex’s president and chief executive officer. “Since we acquired the former PharmaCore business, now Cambrex High Point, in October 2016, we have invested over $5 million at the site and this is set to continue with both the strategic building acquisition and subsequent fit-out. By the time of its completion we will have nearly tripled the workforce at the site to approximately 150 staff.”
The High Point facility produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100 kg in support of clinical trials from Phase I through to Phase III. The site is licensed with the U.S. Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances.
In April 2017, Cambrex completed the construction and validation of a new $3.2 million, 11,000 sq. ft. analytical laboratory at the High Point facility to support growing customer demand for analytical development and validation services in support of clinical stage cGMP products.
Also, in May 2018, Cambrex completed of a new clinical manufacturing suite with 2000 liter reactors and a 0.6 sq. meter hastelloy filter dryer to manage increasing demand for clinical APIs.