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26 Sep 2018

Cambrex to create process development and clinical supply center of excellence

Cambrex High Point facility.

Center will also focus on the development of new technologies, innovative chemistry and engineering solutions.

Cambrex is to establish a center of excellence for API clinical supply and process development at its site in High Point, North Carolina. Cambrex will acquire its currently leased 35,000 sq ft facility, as well as an adjacent 45,000 sq ft building, which will be fitted out with kilo-scale and pilot-scale vessels, continuous reaction production, and chemistry, engineering and analytical development laboratories.

The purchase of the current and adjacent facility is in response to growing customer requirements for clinical supply manufacturing, analytical and chemical development. The center will also focus on the development of new technologies, innovative chemistry and engineering solutions as well as expertise in 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 US,” commented Steven Klosk, Cambrex’s President and CEO. He added: “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.”

At its High Point facility, Cambrex 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 US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances. The acquisition enhanced Cambrex’s portfolio of small molecule API services and complements its large scale, multi-purpose manufacturing facilities in the US and Europe.

In April 2017, Cambrex announced that it had 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.

In addition, in May 2018, Cambrex announced completion of a new clinical manufacturing suite with 2000-L reactors and a 0.6 m2 hastelloy filter dryer to manage increasing demand for clinical APIs.

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