Chesapeake Biological Laboratories Inc. cut the ribbon yesterday on a $16 million plant where it will put smallpox vaccine into vials, the final step in a manufacturing process designed to stockpile enough of the vaccine to protect every U.S. civilian.
The southwest Baltimore contract manufacturer, a subsidiary of Winnipeg, Manitoba-based Cangene Corp., built the 12,000-square-foot plant under a shroud of secrecy in just three months - years faster than usual for biotechnology plant construction. The challenge was all the greater because the plant, in which gowned and masked employees will work under sterile conditions designed to discourage every last speck of dust, was built partly from the musty shell of a converted steel warehouse.
"This really is unparalleled in the pharmaceutical industry," CBL President John Botek said as he started off festivities attended by Baltimore Mayor Martin O'Malley, Rep. Robert L. Ehrlich Jr. and others.
CBL doesn't yet know exactly how much vaccine it will be putting into vials, or even when the vaccine will start to arrive; that depends on how fast the contractors making it can deliver. But yesterday, company officials guiding booty-wearing guests on a tour said the plant would be sterilized, tested and ready by next month. Production could then go on for more than a year.
CBL will put the vaccine into vials as a subcontractor to Acambis Inc. of Cambridge, Mass. The U.S. Health and Human Services Department announced in November that Acambis had won the $428 million contract to develop 155 million doses of smallpox vaccine. The contract is part of a broader government effort to stockpile enough vaccine to protect U.S. citizens in the event of a bioterrorism attack.
Subcontractor Baxter International Inc. will manufacture the vaccine in Austria and ship it to Massachusetts, where Acambis will purify it.
The vaccine will be shipped to CBL's new plant at 730 W. West St. in the Carroll-Camden Industrial Park. There, it will be put into vials, freeze-dried, capped and sealed. The freeze-dried product will have to be reconstituted as a liquid before it's injected.
CBL didn't disclose how much the job may mean in revenue, but it's almost certainly in the millions of dollars. Contract manufacturers generally charge drug companies from $2 to $4 per vial for products that are freeze-dried, as the smallpox vaccine will be.
A product as specialized as the smallpox vaccine could be expected to be priced even higher. The government, CBL said, ultimately could order up to 2.5 million vials, each of which will contain 100 doses.
The company hired about 20 new employees because of the plant expansion. Another 125 work in the adjacent, 70,000-square-foot plant on Paca Street. Company officials said the vaccine plant workers have bachelor's degrees and will make annual salaries in the upper $30,000 to low $40,000 range. Several more people remain to be hired.
The new contract is the highest-profile sign yet of the turnaround at CBL, which was purchased last year by Cangene. CBL had a new Baltimore plant but widening losses when it hired Thomas P. Rice, a former pharmaceutical company executive, as chief executive officer in December 1998. Rice closed the company's Seton experimental facility and concentrated operations at its Camden plant. The company, which large pharmaceutical and biotechnology companies often hire to make their drugs, previously had sufficient capacity only to manufacture drugs for smaller-scale human tests.
But CBL has expanded, putting about $5 million into its Paca Street plant. Now it has enough capacity to make products for Phase III trials - the last and largest stage of human testing - and even for the market. Rice said the company already is doing so, but declined to name clients.
"We're going to keep building in this town," he said in a brief interview before the ribbon-cutting ceremony. "We're not done yet."
CBL Vice President Vicki Wolf-Long said the company also hopes to win a contract to manufacture the substance used to reconstitute the vaccine into a liquid.
Company officials, contractors, architects, engineers and government officials seemed most proud yesterday of the speed at which the plant was built. The feat involved a contractor - Whiting-Turner Contracting Co. - that began digging even as architect Michael C. King worked furiously through the night to finish the plans.
The city quickly squeezed the building permit process down from months to weeks.
"A quick project takes three years," said Bill Porter, one of the project's engineers. "A lot of 'em take as many as five."