Cambrex Expands Drug Manufacturing Plant in High Point

By Barry Teater, NCBiotech Writer

Cambrex Corp., a contract manufacturer of small molecules and active pharmaceutical ingredients (APIs) for drug companies, will invest $2.4 million in an expansion of its pilot plant in High Point to meet growing business demand.

The expansion will include a new 400-square-foot reactor suite that will increase the plant’s reactor capacity by 30 percent, the company said in a news release.

“This expansion will facilitate the scheduling of cGMP (contract Good Manufacturing Practices) campaigns for our customers and assist in meeting clinical deadlines,” said Brian Swierenga, vice president of operations and site director for Cambrex High Point. “In addition, with the new filter dryer we will be able to run small-scale batches to demonstrate their feasibility for scale-up.”

The reactor suite, the plant’s fourth, will feature two 2,000-liter reactors and a 0.6-square-meter Hastelloy filter dryer. It is expected to be fully operational by early 2018.

In a second investment at the High Point site, Cambrex will upgrade its analytical chromatography data systems for quality control and analytical research and development with new software. The new Empower 3 software will bring enhanced capability, integrity and compliance to the site’s analytical systems, in line with the increasingly stringent demands of the U.S. Food and Drug Administration, the European Medicines Agency and other regulatory agencies, the company said.

Cambrex acquired the 35,000-square-foot High Point site from privately held PharmaCore in October 2016 for about $25 million. The site employs about 60 people, according to the company’s website.

The facility 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 to manufacture Schedule II to Schedule V controlled substances.

Cambrex was established in 1981 as CasChem when it acquired the castor oil and derivatives product lines from NL Industries. Through multiple acquisitions it has since transitioned from a fine chemical manufacturer to a contract manufacturer of small-molecule therapeutics.

The company offers APIs, advanced intermediates and enhanced drug delivery products for branded and generic pharmaceuticals. Its development and manufacturing capabilities include enzymatic biotransformations, high-potency APIs, high-energy chemical synthesis and controlled substances. 

Cambrex, publicly traded on the New York Stock Exchange, has about 1,200 employees at its headquarters in East Rutherford N.J., and its manufacturing facilities in High Point; Charles City, Iowa; Karlskoga, Sweden; Paullo (Milan), Italy; Tallinn, Estonia; and Wiesbaden, Germany.

Thu, 05/18/2017 - 00:00