The building with the missing wall at Ben Venue Laboratories Inc. eventually will help the drug manufacturer secure more business from companies developing drugs to fight cancer, company officials say.

The Bedford company, which manufactures injectable drugs on a contract basis, is in the midst of constructing a $139 million plant devoted to the production of cytotoxic and genotoxic compounds — drug compounds, many of which are used in cancer treatments, that are toxic to cells and genes.

The building, which will be about 244,000 square feet when finished, should help Ben Venue attract more business because some international regulators require drug companies to use isolated facilities when making cytotoxic and genotoxic compounds, said David Henderson, vice president of operations.

“There’s no question that we believe this will create another market niche for us that’ll help sustain our growth,” said Mr. Henderson, noting that demand for potent cancer drugs is growing.

Ben Venue started work in July on a $71.5 million addition to an unfinished $67 million building on the north edge of the company’s property. The company is scheduled to finish the expansion by the end of 2008, and it will begin making drugs in the combined structure as soon as it receives approval to do so from regulatory agencies, such as the U.S. Food and Drug Administration.

Ben Venue plans to hire 150 to 200 people within about two years of the building’s completion, Mr. Henderson said. Some of them likely will work elsewhere on the Ben Venue campus, because some current workers likely will move into the new structure. Ben Venue employs nearly 1,200 people and is Bedford’s largest employer.

Bedford City Council in July gave the company a 10-year, 80% abatement on property taxes for the expansion.

An isolated case

The European Medicines Agency, referred to as the EMEA, in 2002 pressed the Bedford drugmaker to build the facility just for the production of cytotoxic and genotoxic compounds. The agency argues that such facilities prevent toxic drugs from contaminating nontoxic drugs.

Mr. Henderson said Ben Venue’s prior method of ensuring clean production of those compounds was safe, but the company agreed to build the facility because it needs EMEA approval to continue making drugs for the European market. “If we did not do it, somewhere down the line it would have an impact on our license,” Mr. Henderson said.

The facility will have its own entrance, dining facility and locker rooms in order to be self-sufficient. Employees will work with harmful compounds through glass walls equipped with gloves that let them reach through holes in the shield. Ben Venue plans to start advertising those resources to its customers soon.

“It’s going to be a showcase for our company,” Mr. Henderson said. “There’s no doubt about it.”

Both Mr. Henderson and Ben Venue president Tom Murphy said they know of no other large-scale contract drug manufacturer in the United States with an isolated facility for making cytotoxic and genotoxic drugs.

“It should bring us in a broader base of business,” Mr. Murphy said. “Maybe some customers we haven’t been dealing with.”

Julian Wilkins, vice president of drug containment for consulting company PharmaConsult US Inc., also said he knew of no other large contract drug manufacturers with isolated facilities for making cytotoxic and genotoxic drugs. The Bridgewater, N.J., consulting company has talked with Ben Venue about the facility.

Mr. Wilkins said regulators shouldn’t require drug companies to build separate facilities to make cytotoxic and genotoxic compounds because he believes companies can effectively isolate the toxic compounds through other means, such as by working through glass walls. Regardless, the facility should serve Ben Venue well, given that EMEA and other agencies, such as the Brazilian National Health Vigilance Agency, which goes by ANVISA, require isolated production, he said.

“I would think especially in the short term that it would be helpful,” he said.

The EMEA did not return a message left with a press office receptionist Aug. 16. The U.S. Food and Drug Administration does not require separate production facilities for cytotoxic and genotoxic drugs.

Growth spurt

The uncompleted first building and the current expansion originally were supposed to be two separate buildings comprising Phase 5 and Phase 6 in a series of Ben Venue construction projects that have taken place since 1997, when the company was bought by the Boehringer Ingelheim family of pharmaceutical companies, based in Germany.

The first was to have been a typical production facility, and the second was to have been used to make cytotoxic and genotoxic compounds. Ben Venue combined the projects to speed up construction of the facility for harmful drugs, which originally was scheduled for completion in 2012.

The company then walled off the side of the first building that had been connected to the rest of the campus and tore off the brick wall on the side where it is building the expansion. Ben Venue officials now refer to both phases as the Phase 5 Conversion Project.

Ben Venue plans to start Phase 7, the replacement of the original Ben Venue building, in 2009.

Source: crainscleveland.com