When dignitaries get their first glimpse today of the nearly complete Maryland BioCenter, they will be seeing a facility that many hope will put the state at the forefront of an important new industry.
It's hoped the first batches of some of the world's most important new biologically engineered vaccines and drugs will be made at the new center.
But a big question looms:
Can the $21 million state-of-the-art facility on Johns Hopkins' Bayview Research Campus draw enough business to be a success? Bio Science Contract Production, the private company leasing and operating the East Baltimore center, has yet to sign a client and that has some of the BioCenter's supporters concerned.
Also it will have two competitors by the time it opens for business in January.
"A lot will depend on how it's marketed. They will have to find and interest companies that are just at the right stage in their product development that they need the BioCenter," said Tom Fisher, senior vice president for operations at Martek Biosciences Corp., a Columbia-based company developing medicine and food additives from micro algae.
Still, he and other industry experts say that the center's presence could prove pivotal for Maryland.
And Jacques "Jack" Rubin, chairman of Bio Science Contract Production, who is to speak today in a preview of the facility for politicians and state officials, says he isn't concerned about building a clientele because interest from the industry is high.
State and local experts say that the BioCenter has the potential to create more jobs as the state's biotechnology industry matures and grows.
The hope is that the production center will help retain Maryland companies that finally cash in after spending years -- and millions of dollars -- on biotechnology research.
Moreover, industry experts say, without this high-tech manufacturing center for the mass culturing and fermenting of cells and proteins, Maryland could not hope to become a national player in what many predict will be fantastic advancements in medicine, pharmacology and other sciences during the early 21st century.
"There is an enormous evolution under way in the biotechnology industry. So Maryland's decision to build this center is a pretty smart move," said Dr. Charles Hamner, executive director of the 11-year-old North Carolina Bioprocessing Center and a nationally recognized expert on the industry.
"Companies are shifting from the research and innovation stage to the production stage so they can get their discoveries into the field and clinical trials," he added. "Any state that wants to have a viable biotechnology industry will absolutely need a bioprocessing center available, or they risk losing good companies."
One of the key reasons Annapolis committed a hefty $16 million of the $21 million to build the BioCenter was to ensure that Maryland-based start-ups don't abandon the state when they are ready to go into full production, said Patrice Cromwell, executive director of the Maryland Bioprocessing Center, the state agency that oversees the BioCenter and leases it to Bio Science Contract Production.
Bio Science Contract Production's 20-year lease with the state calls for a payment of $500,000 for the first year, $1 million annually in years two through four, and $1.5 million annually for years five through 20.
The BioCenter is designed to handle the manufacture of biologically engineered drugs and vaccines for what's called "early stage" trials right up through the commercial sale of a new medicine.
The nonprofit BioCenter will help attract biotechnology companies with awards ranging from $50,000 to $200,000.
Mrs. Cromwell and other backers of the BioCenter believe the facility's potential for success is strong because it will offer cash-strapped companies an alternative to current options.
"When you go from R&D; to manufacturing, you only have two options right now," said Mrs. Cromwell. "You can strike a strategic alliance with a big company that has the resources, which often leads to you having to sign licensing agreements and royalty payments if the product does eventually get approved.
"Or you need $10 to $20 million to build your own manufacturing facility and must hire hundreds of people. That's too big a risk when you are dealing with something that is going to take years getting through the FDA [Food and Drug Administration] approval process and may eventually flop."
Clients will pay, depending on the product, on average about $12,000 a day to have BioCenter technicians produce large enough quantities of their discoveries so that they can be used in human trials.
Mr. Fisher at Martek says that while that may seem high to outsiders, it's a "drop in the bucket" in terms of the total cost of developing a new product from the laboratory to human trials. "It's a good value if in the end you finally are able to get the product commercialized," he said
But it is also true that there are other contract bioprocessing facilities in the U.S., and some of the big pharmaceutical companies have also begun offering contract-only work.
London-based Celltech Biologics, which was one of the early companies interested in operating Maryland's BioCenter, is the first to open a contract bioprocessing facility in the U.S. The company sold bonds to build a $30 million facility in New Hampshire.
Construction has started in North Carolina on a contract bioprocessing center that will be twice as large -- 109,000 square feet -- as the East Baltimore center.
The center will be in North Carolina's Research Triangle Park, home to dozens of biotechnology companies, several of the nation's pharmaceutical giants and three major universities.
The $60 million facility, called Corning Bio, will be built by New York-based Corning Pharmaceutical.
It's expected to open in late 1996, and will focus on serving the market for producing biologically engineered products for late stage testing and sales.
Mr. Rubin argues the BioCenter's distinct advantage is that it will be a "no-strings attached operation."
Mr. Rubin said he expects clients to need the center's services for a month at a minimum.
What they will get for their investment, Mr. Rubin says, are the resources of a staff of 60-100 scientists and technicians, a
building designed to produce bulk quantities of medicines, and one of the cleanest, most secure environments in the country.
Moreover, when a biotech company leases one of the four fully-equipped "suites" at the BioCenter, they will be allowed to bring their own scientists and staff -- something other bioprocessing centers generally don't allow.
Mr. Rubin and Mrs. Cromwell said that BioCenter would provide fledgling companies with hands-on training in the manufacture of large supplies of medicines.
With all this going for it, though, what the BioCenter could really use, everyone agrees, is a client. Mr. Rubin says he is negotiating with a number of companies but he refused to reveal their names.
Dr. John Scarlett, executive vice president and founder of Corning Bio, says the three new facilities -- in Maryland, New Hampshire and North Carolina -- should complement rather than compete with one another, since each has a slightly different focus.
"A lot of small biotech companies, and even some of the larger ones, are deciding they would just as soon save the huge expense of building a production facility, and pay someone else a fee to handle it for them," he said. "It's cheaper, more efficient. This out-sourcing is one of the most important trends in the industry."