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Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.
Cambrex Corporation will establish a center of excellence for API clinical supply and process development at its site in High Point, North Carolina, the company announced in a Sept. 25, 2018 press release. The Center of Excellence received a commendation in the 2018 CPhI Pharma Awards “Excellence in Pharma: Contract Services and Outsourcing” category.
The company will acquire its currently leased 35,000-ft2facility and an adjacent 45,000-ft2building, which will be fitted out with kilo-scale and pilot-scale vessels, continuous reaction production, and laboratories for chemistry, engineering, and analytical development. The purchase of the current and adjacent facility is in response to growing customer requirements for clinical supply manufacturing and 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 [and] process and technology development in the U[nited] S[tates],” 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.
The company had expanded the High Point facility in the first half of 2018, completing a pilot-plant expansion and analytical lab construction and adding continuous flow reactor platforms.
The company also announced in an Oct. 5, 2018 press release that it would invest approximately $3 million to increase the capacity and efficiency of one of its cGMP manufacturing facilities at its site in Paullo, Milan, Italy. The investment will include the installation of a new 12,000-L reactor, as well as reconfiguration of the layout to allow for the replacement of existing centrifuges with new, more efficient equipment.