Cambrex invests to increase pilot-scale API capacity at its High Point, NC facility

Increases site’s reactor capacity by 30%.

The new 400-sq. ft. suite, which is being constructed to meet growing business demand, will feature two 2000-L reactors and a 0.6-m2 Hastelloy filter dryer, and is expected to be fully operational by early 2018.

“This expansion will facilitate the scheduling of cGMP campaigns for our customers and assist in meeting clinical deadlines,” commented Brian Swierenga, VP, Operations and Site Director for Cambrex High Point. He added: “In addition, with the new filter dryer we will be able to run small-scale batches to demonstrate their feasibility for scale-up.”

In a second investment at the High Point site, Cambrex is to upgrade its analytical chromatography data systems for QC and analytical R&D to new, Empower 3 software. Empower will be introduced in Q3 and Q4 of 2017 and will bring enhanced capability, integrity and compliance to the site’s analytical systems, in line with the increasingly stringent demands of the FDA and EMA among other agencies.

Cambrex acquired the 35,000-sq. ft. High Point site, formerly PharmaCore, in October 2016. At the North Carolina 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 US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances. The acquisition enhances Cambrex’s portfolio of small molecule API services and complements its large scale, multi-purpose manufacturing facilities in the US and Europe.