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GMP Lab Could Speed Drug Development
GRAND RAPIDS — A Good Manufacturing Practice lab that's slated to open on Michigan Street hill in June 2007 could lead to the development of new drugs and treatments for human clinical trials and help boost the region's life sciences industry.
The facility will be housed in 5,000 square feet of existing space within Grand Valley State University's Cook-DeVos Center for Health Sciences. It's being established through a partnership between GVSU and the Van Andel Institute. The GMP lab is designed to take discoveries made at the institute and turn them into new pharmaceutical and biological drugs and therapies. The lab will do the same for customers throughout West Michigan and likely throughout the Midwest, said Matt Dugener, executive director of the West Michigan Science and Technology Initiative.
Both state and federal legislators helped secure funding for the project: Michigan Gov. Jennifer Granholm and State Sen. Ken Sikkema were instrumental in securing $4.5 million in state funding. Congressman Vern Ehlers had helped secure $462,555 in federal funding for the project two years ago from the U.S. Department of Health and Human Services budget.
The lab will eliminate the need to contract with out-of-state laboratories for GMP work, and the partners anticipate there will be a healthy demand for the lab's services.
"The state decided to fund this initiative to provide researchers, small companies and large companies the ability to do good manufacturing in the state of Michigan, rather than going out to the coasts and waiting sometimes four to six months to get their GMP contracts fulfilled," Dugener added. "This will really expedite the process."
John Van Fossen, director of development for the VAI, said the state gave the institute the funding in two appropriations: There was a $3 million line item earmarked within the 21st Century Jobs Fund this year and the other $1.5 million came out of last year's Tri-Technology Corridor Fund. Both appropriations to the institute were designated to build the GMP facility, he noted.
"We couldn't build the facility until we had acquired all the funds, because of the facility improvements that need to take place and the equipment purchases that had to be made," Van Fossen explained.
Good Manufacturing Practice is a set of U.S. Food and Drug Administration regulations, codes and guidelines for the mantufacture of drugs, medical devices, diognostic products, food products and active pharmaceutical ingredients. The regulations primarily address issues such as sanitation, process violation, equipment and document traceability and personnel qualifications.
The FDA has to approve the architectural engineering plan for the GMP facility first and upon the facility's completion, and has to validate the finished facility and its equipment, Dugener said.
"The whole approval process fits into our timeline of having the facility open by June of 2007," he said.
Several months ago, the VAI approached GVSU about the possibility of using some space in the Cook-DeVos Center for a GMP lab, he said. The university liked the idea, and the two institutions set about working out all the details, such as the appropriate size of the facility and the best location for it within the center.
David Van Andel, chairman and CEO of the VAI, said the lab will help the institute expand its role in bringing new drugs to the market.
"We will now be able to produce new, high quality pharmaceutical and biological therapies in sufficient quantity and at reasonable cost for use in clinical trials," Van Andel said.
Dugener said an organization separate from both the VAI and GVSU will be created to operate the facility, which will be located on the fifth floor of the center. The organization will hire an executive director, who in turn will hire about four to six bio-manufacturing professionals to staff the lab.
Once it is in operation, GVSU will simply serve as a "landlord" to the lab and the VAI as one of its customers, Dugener said. He said the lab here will be the first GMP facility in the state that's not affiliated with a private pharmaceutical manufacturer.
"I like to think of the GMP as a critical piece of infrastructure that will keep Grand Rapids competitive in the life sciences industry," Dugener said. "Companies or researchers that develop new drugs, if they have to wait four to six months to get those drugs through the Good Manufacturing process, that really puts them at a disadvantage. Having the lab right here in the community will shorten that time and get our drug discoveries on the market quicker."
Birgit Klohs, president of The Right Place Inc., said the GMP facility will help move forward the whole life sciences commercialization strategy for the region forward. The economic organization's Karen Wolf, vice president of emerging markets, participated in the planning for the GMP.
"This is another piece of very important infrastructure as we're building up our life sciences capabilities," Klohs said. "If we don't have it, the long-term impact of our life sciences commercialization efforts will be lessened."
Grand Rapids Mayor George Heartwell said the 21st Century Jobs Initiative also is a nice piece of the life sciences picture in Grand Rapids, because it kick-starts the commercialization of new discoveries and technology innovations coming out of the corporate research and development done in this area. Also, in his recent state of the city address, Heartwell proposed the creation of a "knowledge-based tax abatement" for urban areas.