Cambrex Corporation, the leading manufacturer of small molecule innovator and generic active pharmaceutical ingredients (APIs), has announced that it is expanding its High Point (NC, USA) facility with the addition of a new $3.2 million, 11,000 sq. ft analytical laboratory.
The investment comes in response to growing customer demand for analytical development and validation services in support of cGMP products at the clinical stage.
Installation of equipment, including HPLCs, mass spectrometers and support equipment, will commence in Q3 2017, with validation and start up anticipated in Q4 2017.
As a result of the expansion, Cambrex will add twelve new analytical development scientists to the R&D team. The laboratory will be used to broaden analytical support for customer projects at the High Point site, and forms part of a strategic plan to support Cambrex’s global analytical development and method validation needs.
“There is a growing demand in the industry to better understand and characterise APIs and process intermediates at the clinical stage,” commented Brian Swierenga, VP, Operations and Site Director for Cambrex High Point.
“This expansion reinforces Cambrex’s position as a leader in small molecule API clinical and commercial manufacturing while enabling the organisation to stay ahead of regulatory requirements.”
Cambrex acquired the 35,000 sq. ft High Point site, formerly PharmaCore, Inc., in October 2016. At the North Carolina facility, Cambrex produces complex APIs and intermediates requiring multistep synthetic processes in batch sizes from milligrams to 100 kg to support clinical trials from Phase I 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, multipurpose manufacturing facilities in the US and Europe.
This latest expansion at the facility brings the investment at the site to more than $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.