Cambrex increases pilot scale API capacity

The investment to increase reactor capacity by 30% will take place at the company's High Point facility in North Carolina, USA

Cambrex, manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), is to expand pilot plant capabilities with the installation of a fourth reactor suite. The $2.4m investment will increase the site's reactor capacity by around 30%.

The new 400sqft suite, which is being constructed to meet growing business demand, will feature two 2,000 litre reactors and a 0.6sqm 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,” said Brian Swierenga, Vice President of Operations and Site Director for Cambrex High Point.

This expansion will facilitate the scheduling of cGMP campaigns for our customers and assist in meeting clinical deadlines.

“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 35,000sqft 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.

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