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GMP Lab To Open For Business In July
The former Steelcase facility at 140 Front Ave. SW has a new lease on life as the home of Grand River Aseptic Pharmaceutical Packaging, a GMP (Good Manufacturing Practice) lab established as a joint venture between Grand Valley State University and Van Andel Institute. The lab's executive director, John Bacon, said the GMP lab will be customer-ready sometime in July.
Good Manufacturing Practice regulations are put forth by the U.S. Food and Drug Administration and require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups and errors. As a GMP lab, Grand River AAP has to undergo an audit procedure and get the FDA's "blessing" before it can start operations, Bacon said.
Over the past several months, the lab has been preparing for the audit by documenting the lab's quality system and qualifying its equipment to ensure it will perform as expected, he said.
Grand River has launched a Web site and marketing campaign targeting potential clients, which could include small pharmaceutical companies, large pharma, government institutions and educational institutions. The lab offers fill/finish and freeze-drying services, antiseptic packaging and cold storage to its clients.
"Basically, it's anyone that is developing a drug that they want to bring to market and have reached a point where they have to do clinical trials on humans," Bacon explained. "That's where we come in, because we can take their bulk liquid material and package it down to finger-sized glass vials. We'll do about 3,000 to 10,000 of those vials a batch."
Having the lab here eliminates the need for prospective clients in this region to contract with out-of-state laboratories for GMP work, and the partners anticipate there will be healthy demand for the services. Having to get work done out-of-state sometimes means waiting four to six months to get contracts fulfilled.
Grand River APP is an important piece of the growing life sciences industry in Grand Rapids, Bacon said.
"Basically, life sciences industry here wants to be full service: They want to be able to do drug development, clinical trials and right into production," Bacon said. "This facility is the only facility of its kind in Michigan, and there's probably only one other one in the Midwest. Geographically, these services are only available on the East and West coasts, for the most part."
Including laboratory, cleanroom and office space, Grand River APP occupies 7,000 square feet of space. Bacon said the facility will have eight to 10 full-time people on staff who have strong backgrounds in the pharmaceutical industry, specifically fill/finish operations — the actual filling of vials and packaging of them. As of early March, Grand River had one customer signed and four to six more companies had expressed interest.
Bacon said the lab is basically in Phase I right now: the processing of liquid injectable products. In Phase II, which could happen within a two-year timeframe, the lab could expand to include a mixing formulation process, or go into solid dosage — as in oral dose pill form — or even go into topical products, such as lotions, Bacon explained.
"In terms of five years, we expect to double or perhaps triple in size," Bacon said.
Grand River APP has both wet and dry labs as well as sterile cleanroom space — space reserved for the processing and filling of vials. A wet lab typically has captured ventilation for specific processes, such as cleaning or etching, said John Vander Wall, president of Midwest Cleanroom Associates, the company that built the lab for Grand River APP. A dry lab typically has steam hoods and biological safety cabinets, he said.
During construction of a cleanroom, an aseptic environment has to be maintained through every phase of construction, Vander Wall noted. During construction, his firm typically follows a rigid four- to five-step clean-build protocol.
A cleanroom requires special ventilation equipment that continually cleanses the air to control particle counts. It might also, for instance, have a biological safety cabinet and a pre-gowning and final-gowning room for staff so as to prevent any contamination being passed from one area of the cleanroom to another, he said.
"A cleanroom controls particle counts at the micron level. A laboratory is 'dirtier,' so to speak, but still has certain requirements, in some cases, even gowning requirements. Different protocols have to be used, not only to build a cleanroom but to operate it."
Vander Wall said there were unique challenges in building the Grand River APP because the old Steelcase facility was built in the late 1800s. In order to bring the cleanroom space up to standards, prior to construction Midwest Cleanroom did a lot of cleaning, painting and sealing to avoid introducing dirt from the old structure, he said. He said most of the materials used on a cleanroom's wall and ceilings are non-shedding materials, some of which may have an anti-bacterial coating. The furniture installed in cleanrooms is usually supplied by vendors that specialize in cleanroom furniture.
Midwest Cleanroom builds cleanrooms in the $500,000 to $5 million range, or from 500 square feet to 10,000 square feet, for clients all over the country. It's a full design/build firm that can take a project from conceptual design through completion. The staff includes architects, mechanical engineers, electrical engineers and a product designer.
"This is such a unique industry. We literally work with the brightest minds in the world, and that is so exciting," Vander Wall said.
Both state and federal legislators helped secure funding for the Grand River APP: Michigan Gov. Jennifer Granholm and former 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 state gave the Van Andel Institute the funding in two appropriations: There was a $3 million line item earmarked within the 21st Century Jobs Fund in 2006, and the other $1.5 million came out of the 2005 Tri-Technology Corridor Fund. Both appropriations to the institute were designated to build a GMP facility. HQX