Vetter Expands Clinical-and Commercial-Scale Operations

Vetter, a contract manufacturer of aseptic filling of syringes, cartridges, and vials, is moving ahead with expansions in its clinical- and commercial-scale operations. Its expansions are marked by a new clinical-scale facility in the United States, which will complement its commercial-scale capabilities in Germany.

Vetter is going to open Vetter Development Services USA Inc. at the Illinois Science and Technology Park in Skoie, Illinois, outside of Chicago by the end of 2009. The 24,000-ft² facility will provide aseptic filling of clinical-trial materials for Phase I and II. “The facility allows us to be closer to our customers in North America, particularly US companies,” says Oskar Gold, vice-president of key account management and corporate marketing for Vetter. The facility will be Vetter’s first in the US. The company is leasing the facility and is investing in upgrading the facility, which will be fully operational by the end of 2010. Vetter also provides small-scale capabilities at its facilities in Germany.

The Chicago small-scale facility will complement the company’s commercial-scale manufacturing facilities in Ravensburg, Germany. During the past six years, the company has invested EUR 150 million ($220 million) at its Ravensburg South aseptic filling and packaging facility, with a further EUR 50 million ($74 million) of investment in expanded pharmaceutical production now underway. The Ravensburg South site houses a production facility, a final assembly and packaging plant, and a laboratory for ongoing production-related analysis. Vetter is currently adding a third production line, which is scheduled for completion by mid 2011. The company recently installed six automatic packaging lines at it the secondary packaging plant, which came on line in May 2009. The expansion allowed the company to double its packaging production capacity at the site.

In addition to its Ravensburg South facility, Vetter also operates commercial-scale facilities in Ravensburg City and Langenargen, Germany. The Ravensburg City facility includes production capabilities for single- and dual-chamber syringes and cartridge systems and related facilities for technical support. The Langenargen facility also provides production capabilities for single- and dual-chamber syringes and cartridge systems. Gold points out that each facility operates with its own independent quality systems, and therefore can serve as a second source for supply. “In the risk-mitigation strategies of many pharmaceutical companies, it is important to have more than one facility producing supply. By having multiple facilities, we are able to provide that security of supply,” he says.

Gold also points out that expanding its clinical-trial materials capabilities is an important focus for the company. “In early-development stages, companies are looking to get material as soon as possible in order to meet developmental timelines,” he says. “But in developing a process for early-stage materials, it is valuable for a company, particularly smaller biopharmaceutical companies, to be able to access the process understanding that will be needed for a commercial product and the related regulatory filings. We can provide that understanding with a view to scale.”

Reflecting that commitment, earlier this year Vetter launched a quality assurance program for its project managers for purposes of them gaining certification under the International Project Management Association (IPMA), a nonprofit organization that represents 45 national project management associations and more than 55,000 members on an international level. To be eligible, each participant in the certification program must have at least three years of experience in project management, plus two years of practical work leading a project. The candidate is assessed on a wide variety of criteria, including the ability to plan, control, communicate and solve problems. Certification then is awarded to those who demonstrate deep organizational knowledge, as well as leadership qualities.

“That quality philosophy is at the center of our operations,” concludes Gold.