![]() Scott Morris, an optical engineer with BioVigilant Systems Inc., views data on a laptop computer that takes readings from a box that detects biological particles. Such particles can contaminate food or medicines. The Northwest Side company is awaiting approval of its technology by the federal Food and Drug Administration.
Benjie Sanders / Arizona Daily Star
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Detecting contaminationARIZONA DAILY STAR
Tucson, Arizona | Published: 07.10.2007
On Scott Morris' lab table sat a simple box filled with circuit boards and electronics, with wires wending their way to a laptop that displayed a row of symbolic traffic signals.
Morris hovered over the box and quickly rubbed his arm, which shook off skin cells and bacteria. The signals on the laptop turned from a comfortable green to a dangerous red.
"Well, look at that," said Morris, satisfied that the device had sensed the contaminants from his arm and had registered an alert.
Morris and other optical engineers at BioVigilant Systems Inc. are developing what could change the pharmaceutical industry's methods of spotting contaminants before they get packaged into drugs that millions of consumers use.
BioVigilant, a Northwest Side firm that has developed optical devices to instantly detect microbial contamination, is seeking product approval from federal regulators while raising development money. About $3.7 million from the company's second round of venture capital funding is in place.
While BioVigilant's detection systems were initially marketed for homeland security applications, CEO Deward "Dewey" Manzer said the company is now "pursing the pharmaceutical-manufacturing market very vigorously."
Still, the firm is eyeing military, domestic security and food-processing applications.
Here's how the machine would work in a drug-production "clean room":
Air is sucked into one side of a machine as a laser inside shines on air particles, scattering the light. The scattered light is measured by sensors that determine the size of each particle and whether the particles have the biological properties of bacteria or other red-flagged contaminants.
If approved by the U.S. Food and Drug Administration, BioVigilant's device would allow for "more real-time microbial monitoring" within seconds, said Doug Rufino, a product development director with DSM Pharmaceuticals Inc., a North Carolina-based manufacturer.
What makes BioVigilant's detection systems better, he said, is that it detects contaminants much faster than some of the current testing systems do.
Rufino said his company currently uses "media-based" detection systems, such as cell culturing in petri dishes, to sniff out contaminants. But current detection methods, he said, can take seven to 10 days to yield results, costing the company lots of money if it has to pull back drugs.
"It's got huge potential to make sure that our injectable products are safer," said Raymond Woosley, president and founder of the Tucson-based Critical Path Institute, a nonprofit partnership with the FDA that is working on ways to improve drug safety and development.
"It's very inefficient to make a huge batch of product and then realize a week later you have to throw it away," Woosley said.
Such potential savings are attracting the attention of drug makers. In late May, Manzer said, BioVigilant officials met with a consortium of a dozen pharmaceutical companies. The firm has since received a purchase order from one of those companies, which company officials declined to name.
The next steps for BioVigilant, Manzer said, are to pursue the FDA approval process and sell the firm's testing systems for nonregulatory uses, such as training. The FDA's approval is required in the drug-manufacturing process, not just for the drugs themselves.
In May 2006, BioVigilant announced the completion of the first $4 million Series A round of financing, led by Battelle Ventures LP. At the time, the company said the funds would be used for product development and testing; establishing manufacturing facilities; and increasing sales and marketing.
BioVigilant expects $4.2 million in place by the end of this month.
Battelle's limited partner is Battelle Memorial Institute, which helped create the Arizona Biosciences Roadmap, a 10-year plan started in 2002 to guide the state's efforts in such fields as biotechnology and bioengineering.
BioVigilant, founded in November 2002, first developed technology for the government to detect biological agents, such as anthrax.
● Contact reporter Jack Gillum at 807-8012 or at jgillum@azstarnet.com.
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