Cambrex has completed the construction and validation of a new $3.2 million, 11,000 sq. ft. analytical laboratory at its High Point, NC facility. The investment was driven by a growing customer demand for analytical development and validation services in support of clinical stage cGMP products.

The expansion required the sourcing, acquisition, installation and qualification of more than 20 new analytical instruments, including HPLCs, mass spectrometers and support equipment. Cambrex plans to hire 12 new analytical scientists as a result of the investment. The laboratory’s primary function is to broaden analytical support for customer projects being developed and manufactured at the High Point site, while forming part of a strategic plan to support Cambrex’s global analytical development and method validation needs.

“The addition of this new facility further expands our capabilities in method development and qualification and validation, to ensure successful project development in the short term, and allowing efficient technical transfer of projects to commercial scale in the future,” said Brian Swierenga, vice president, operations and site director for Cambrex High Point. “This expansion is part of Cambrex’s on-going strategic plan to increase development capacity and resources in North America.”

Cambrex acquired the 35,000 sq. ft. High Point site, formerly PharmaCore, Inc., in October 2016. At the facility, Cambrex produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100kg to support clinical trials from Phase I to Phase III. The site is licensed with the U.S. 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.

This latest expansion at the facility brings the investment at the site to over $5 million since the acquisition by Cambrex, and follows the announcement in May 2017 of an increase in pilot scale manufacturing capacity at the site.