Manufacturing facility news in brief

By Gareth Macdonald

- Last updated on GMT

Related tags Vice president’s periodic round-up of developments in the pharmaceutical manufacturing space includes news on MannKind, Nycomed, ABS and Tris.

Nycomed optimises its European manufacturing network

Swiss drugmaker Nycomed says it will focus its European production operations at five dedicated centres of competence located in Oranienburg and Singen in Germany; Lyszkowice, Poland; Linz, Austria; and Asker, Norway.

The move, which will also see Nycomed transfer production operations at two plants in Denmark and one in Finland to other sites, will affect approximately 250 employees as they are implemented over the next few years.

In March 2008, Nycomed announced that it will move its chemical production of APIs from Singen in Germany and Linz in Austria to the joint venture company Zydus Nycomed in India and the joint venture partner plants in India.

Our decisions to restructure our manufacturing network will allow Nycomed to remain competitive in a tough market environment, where pressure on costs and fast market introduction has become critical​,” said Barthold Piening, Nycomed’s executive vice president operations.

MannKind completes new Afresa production factory

MannKind has opened its new 263,900 square foot facility in Danbury, Connecticut, completing the building phase of the firm’s $200m investment at the site. The plant will produce the inhaled insulin product Technosphere, which has been renamed Afresa for the US market.

The facility is now in the process of being qualified and readied for pre-approval inspection by the US Food and Drug Administration (FDA). It features state-of-the-art production equipment and includes expansion space that will allow production capacity to be increased to meet expected demand over the next few years

Analytical Bio-Chemistry Laboratories' new contract facility

US-based Analytical Bio-Chemistry Laboratories (ABC) has opened its new, 90,000-square-foot pharmaceutical development facility at the University of Missouri's Discovery Ridge Research Park. The new unit more than doubles the company's previous contract production capacity

In July, the FDA completed a pre-approval and general quality systems audit of the facility, which resulted in no 483 regulatory deviations.

John Bucksath, senior vice president and general manager of ABC's Pharmaceutical Division said that all laboratory systems are "validated, and scientific teams are quickly settling into their new home​."

"We are wrapping up a carefully choreographed project plan and I'm delighted to report that the transition of pharmaceutical operations went very smoothly​," he said.

The company added that while it will continue operating its chemical services and synthesis operations at its original campus located about five miles east of Columbia, the Discovery Ridge expansion frees up space for business to grow as well.

Tris Pharma completes plant expansion

Tris Pharma has expanded its research and manufacturing facility in South Brunswick, New Jersey. The firm said that the new 15,000 square feet of space at the company’s FDA-compliant current good manufacturing practice (cGMP) facility will enable it to install extra commercial scale production equipment.

Ketan Mehta, CEO and founder of Tris Pharma said that successful completion of the expansion demonstrated that: "the company is on a steady and stable path as charted​,” and added that the “FDA's assurance of our facilities and the recent investment in our capabilities means we have ample infrastructure with which to leverage our exciting pipeline of drug delivery technologies and services​."

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