Sunday, September 18, 2011

Significant Updates to our Regulatory Pages on

We have very recently updated all of our Regulatory Pages to better reflect the most current perspectives, expectations and guidance from the U.S. FDA, EMA, Australian TGA, Japanese PMDA, ICH, as well as added an expanded page that discusses the regulatory impact of changing acceptance levels and microbial specifications. Please visit our Regulatory starting page at Links to each section can be found at the top of this page.

Look for more revisions to our website in the upcoming month, especially in the area of available technologies and implementation strategies. Our Blog and Newsletter will announce when our updates are effective (you can sign up for our FREE monthly newsletter at

Sunday, September 11, 2011

Nature New Focus of USF Lab Targeting Biological Terror

There's some very interesting research being conducted (literally) right in my own back yard. The University of South Florida's (USF) Center for Biological Defense is focused on the emerging infections cooked up by Mother Nature herself. Here is an overview of what's happening at the Tampa campus:

Some people were skeptical when the Center for Biological Defense opened at the University of South Florida 11 years ago. There had been only one biological attack in U.S. history – a Salmonella poisoning at an Oregon salad bar that sickened 751 people. Within two years, the fledgling lab was Florida's bioterror research and detection center, with up to 100 samples of potentially deadly white powder arriving for testing every day. Soon it would get $4 million from the U.S. Department of Defense.

Today, $67 million later, the USF Center for Biological Defense is focused on a different kind of threat – the emerging infections cooked up by Mother Nature, whom lab supervisor Andrew Cannons called "a much better terrorist than man could ever be."

Judging by the five security doors a visitor must pass through to reach one of the labs, it's work that requires a good deal of protection. USF is trying to be ready for "what's around the corner," Cannons said, be it a deadly new virus, antibiotic-resistant organism or food-borne illness. And the grim truth, Cannons said, is that the operation might not exist if not for the anthrax letter attacks that closely followed the Sept. 11 attacks on the World Trade Center towers.

Before most people had even heard of anthrax or the antibiotic Cipro, Phil Amuso, of the Florida Department of Health, and then-USF research vice president George Newkome sketched out the biological defense center on a Dunkin' Donuts napkin. Biological dangers weren't at the top of people's minds, but the threats were out there, Amuso said. "We were looking for ways DOH could work with the university" to deal with them if they did emerge.

In 2000, U.S. Rep. C.W. Bill Young, a Republican from Seminole, helped USF get about $1 million to work in partnership with the Department of Health, drawing on research from the University of Florida, University of West Florida and Florida Atlantic University. "I saw a growing threat from people around the world who were anti-American and I was concerned about someone who might try to poison our water supplier or damage air filtration systems," Young said.

"After 9/11, the threats became far more serious and far more specific."

About a week after the attacks, anthrax spores spilled out of letters delivered to two U.S. senators and several media offices, including the National Inquirer in Lantana, Florida. Five people eventually died.

The following week, on Sept. 26, USF announced the center had been awarded $4 million to build a system to prepare public health workers to deal with bioterrorism attacks. The next year it announced a $9 million Department of Defense grant. "It went up and up and up," Cannons said.

The center focused heavily on helping emergency responders gather samples, creating a streamlined process that ensured the sample would be preserved untainted and workers would be protected. Then they developed a fast way to figure out whether any substance was dangerous. The new test could identify anthrax spores in about 15 minutes. That led to rapid new methods for genetically identifying the "bugs" and finding out if they had been seen elsewhere and would respond to antibiotics or not.

Along the way, the center amassed "a unique collection of bacteria that no one else has," Cannons said. It includes about 1,500 strains, "most of them not nasty." The lab has a federal biosafety level of 3; the highest is 4. Level 3 includes bacteria and viruses that can be deadly but are treatable. It follows strict Centers for Disease Control safety rules, Cannons said.

The center keeps a low profile in a state Department of Health building on the Tampa campus of USF. It doesn't hide its presence, but it doesn't advertise it, either. Everything except beyond the lobby is behind one or more locked doors. No photography of the lab equipment is allowed. Cannons didn't explain why, other than to say it was the DOH's rule. "It's not all that exciting anyway," he said.

The biological defense center is quiet these days. Its reduced to pre-Sept. 11 levels. But its mission hasn't changed, Cannons said. It still trains emergency workers on how to handle biological threats. Since it opened, it has trained more than 25,000 people from around the country, said Harry Glenn, spokesman for Rep. Young.

Its Advanced Biosensors Lab continues to refine ways to recognize and identify dangerous organisms. Much of the staff's time is spent testing detection and decontamination equipment developed by others. The center is part of a $1.3 million Defense Department grant to Mote Marine Laboratory in Sarasota to test whether the mucus sharks use to fight infection could help wounded soldiers.

In addition to its work on emerging infections, the center has also begun working with the state Department of Agriculture to develop a food-testing program. "We're trying to be ready," Cannon said. "You can't really know what's coming." That's the nature of these threats. "But you can respond as soon as it happens."

Wednesday, September 7, 2011

Optical Biosensor for Continuous Rapid Detection of Health Threats

Researchers from Stratophase, a firm out of Southampton, United Kingdom, just published a paper in journal Biosensors and Bioelectronics, describing the technology inside their SpectroSens chip, a new optical micro device designed to rapidly detect pathogens and biochemicals. The chip can be loaded into a robust device to simultaneously identify 16 different potential health threats like anthrax and ricin toxin.

The chip works with light that reflects in different wavelengths in different situations. The reflectors, which are called Bragg gratings, will reflect one wavelength and let all other wavelengths pass through unaffected. The specific color it reflects can be correlated with a location on the chip. Interactions between target antigens in the test sample and respective immobilized antibodies on the chip result in localized changes in the refractive-index. This increases the wavelength of the reflected light which can be detected. With one chip it is possible to multiplex sixteen different biological agents like spores, viruses and toxins in real-time. You can either load samples manually or, when continuous monitoring is necessary, the cartridge can be combined with air sampling technology.

The company tested the device first on harmless biological agents like Bacillus atrophaeus (BG) spores, Escherichia coli, MS2 viruses and albumin protein. Thereafter, they tested the method on organisms like Bacillus anthracis (BA) spores, Vaccinia viruses (heat-killed) and ricin toxin. The soluble protein antigens seem to give a higher and earlier response than the larger bacterial and viral antigens, but in the end all were picked up by the detector.

The disposable microchips and robust device are compact and easy to transport, which makes them ideal to do rapid on-site monitoring. The system can be used in security and defense operations, but also in regular in-field medical diagnostics for human and veterinary health.

The paper is in press but is currently available for online purchase through Science Direct.

Optical microchip array biosensor for multiplexed detection of bio-hazardous agents.

D. Bhatta, A. Michel, M. Marti Villalba, G.D. Emmerson, I.J.G. Sparrow, E.A. Perkins, M.B. McDonnell, R.W. Ely and G.A. Cartwright. Biosensors and Bioelectronics. Volume 28, Issue 2. 2011.


An optical waveguide array biosensor suitable for rapid detection of multiple bio-hazardous agents is presented. SpectroSens™ optical microchip sensors contain multiple spatially-separated waveguide channels with integral high-precision Bragg gratings sensitive to changes in refractive-index; selective surface-functionalisation of discrete sensing channels with different antibodies as bio-recognition elements enables selective multi-analyte biological detection. Interactions between target antigens in the test sample and respective surface-immobilised antibodies result in localised changes in refractive-index; the biosensor response manifests as increases in wavelength of light reflected from specific sensing channels. Multiplexed, label-free detection of 8 different biological agents, encompassing bacterial spores, vegetative cells, viruses and proteinaceous toxins has been demonstrated in real-time. Selective detection of Bacillus atrophaeus (BG) spores, Escherichia coli cells, MS2 viruses and ovalbumin (OVA) protein (simulant bio-hazardous agents) was first demonstrated as proof-of-concept; subsequently, detection of Bacillus anthracis (BA) spores (UM23CL2 strain), Franciscella tularensis (FT) cells (live vaccine strain), Vaccinia viruses (heat-killed) and ricin toxin (bio-hazardous agents) was proven. Two optical microchip sensors, each comprising 8 sensing channels were packaged into a single disposable cartridge allowing simultaneous 16-channel data acquisition. The specific antibody deposition sequence used in this study enabled detection of either 4 simulants or 4 bio-hazardous agents using a single consumable. The final device, a culmination of the multidisciplinary convergence of the fields of biology, chemistry, optoelectronics and microfluidics, is man-portable and inherently robust. The performance characteristics of the SpectroSens™ technology platform highlight its potential for exploitation as a ‘detect to warn/treat’ biodetector in security and defence operations.