Local officials hope a new ultra-clean laboratory in the Mayo Clinic Center for Regenerative Medicine will help draw businesses in the burgeoning field.
"It is one of the only few places of its kind on the planet available to companies," said Gary Smith, president of Rochester Area Economic Development Inc. "These are expensive facilities to build, and a lot of companies can't afford that capital investment."
Having opened its doors to visitors only last week, final touches were being applied Tuesday to the sensitive equipment during a tour of the Advanced Product Incubator.
The 3,000-square-foot laboratory and office space anchors half of the third floor of the Minnesota Biobusiness Center. Because the API is hoping to attract business to Rochester in addition to developing therapies within the clinic, the facility was jointly funded by RAEDI, the city of Rochester and Mayo Clinic.
"We're really excited about it and the potential this facility has for partnering with new companies," Smith said. "We see this as a piece of infrastructure that's going to help grow the regenerative medicine industry in the area."
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During the tour, API Director Dr. Atta Behfar and program manager Henry Walker described the unique technical specifications and construction processes required of contractors in order for the lab to pass exacting FDA and European product safety standards. The site is essentially a pair of super-hygienic, "clean room" labs-within-a-working lab, that room itself housed near adjoining contemporary business workspace.
Inner walls are made from aluminum core, Walker said, as opposed to sheet rock and framing. These modular materials then are mounted with sophisticated air-monitoring and particle filtering equipment capable of achieving the near-complete eradication of air particles and control of airflow required to be awarded the FDA's Certified Good Manufacturing Practices designation.
To minimize the shedding of particles into the workspace, workers entering API's clean rooms wear head-to-toe, disposable Tyvec lab garments.
"We clean up the air to the point where we have single particle counts," said Walker. As a point of comparison, the ordinary air space might contain as many as 35 million particles in a similar sized workplace.
The modular clean rooms were built and equipment installed by Gerbig Engineering Company of Burnsville, a firm that has developed clean rooms for NASA. Other building contractors included local builders Benike and HGA architects. The entire facility was built out in the past five months.
Smith spoke by phone from Bio 2015, an international gathering of biotech firms where he says the API site has generated interest from a Boston-based biotech firm considering locating to the area.
Regenerative medicine is the science of engineering living cells to regrow missing or damaged tissue. It is viewed as promising because the repair of diseased tissue shifts practice away from the treatment of symptoms toward the underlying causes of disease.
Regenerative medicine at Mayo holds the advantage of its focus upon so-called "cell-free" therapeutics, Behfar said. The term refers to the fact that API plans to forgo the usual focus on stem cells, which can be costly and too individualized for general use, and isolate instead the molecules used by stem cells to trigger the growth of new tissue. The ability to isolate these cell-free therapies would enable "off-the-shelf" drugs for missing or damaged tissue.
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"We have a broad vision of the therapeutic platform we want to pursue," says Behfar. "It's all completely new stuff, based on therapeutic discovery in the lab right now."
It only awaits partners to help move those therapies into patient care.
