Thursday, April 19, 2012

Our Latest Newsletter Describes Proposed Revisions to RMM Validation Guidance Documents

Our latest newsletter provides an overview of the proposed changes to three RMM validation guidance documents: PDA Technical Report No. 33, USP chapter 1223 and Ph. Eur. chapter 5.1.6. These include an enhanced understanding of the use of statistics, technology updates and regulatory acceptance. To read this overview, please sign up to receive our FREE newsletter by clicking on the following link:

Monday, April 16, 2012

Rapid Micro Biosystems Announces the 2013 Availability of Growth Direct™ Systems for Environmental Monitoring and Sterility Applications

Rapid Micro Biosystems, the provider of automated, non-destructive detection and enumeration technologies in microbiology, today announced the 2013 availability of the next generation of Growth Direct™ applications including environmental monitoring (air, surface and personnel) and sterility testing. A larger illustration of the proposed instrumentation may be viewed by clicking on the image. Now end-users have additional options when looking at potential new rapid microbiology EM and sterility testing opportunities. The full press release describing their new instrumentation may be viewed by clicking on our News Page at

Wednesday, April 11, 2012

TSI Introduces Innovative Solution for Real-time Viable Particle Detection

TSI recently introduced the BioTrak™ Real-Time Viable Particle Counter for monitoring pharmaceutical cleanroom facilities, and we have just added their technology to our RMM Product Matrix. TSI is now the third RMM supplier to provide real-time viable monitoring for clean rooms and other controlled environments. Please visit our RMM Product Matrix to review the system's capabilities, including the use of a gelatin filter to capture microorganisms for growth and further analysis, such as microbial identification. TSI's press release is below.

This unique product detects airborne viable particles utilizing TSI’s patented fluorescence detection technology, based on TSI’s 20 years experience of biological threat detection instrumentation. By minimizing false positives, the BioTrak Particle Counter delivers more confidence in instant detection and identification of viable particles to Quality Assurance Professionals.

In addition, the BioTrak Particle Counter measures traditional airborne particle counts, at 1.0 CFM, fully compliant to ISO-21501-4. The instrument simultaneously displays and data logs viable and non-viable airborne particle counts. The BioTrak Particle Counter provides end users with meaningful data to detect unwanted events and support root cause investigations.

TSI’s President, Tom Kennedy, stated, “We’re excited to announce the launch of the BioTrak Particle Counter, which incorporates TSI’s patented fluorescence technology, to the underserved market for accurate, real-time viable particle detection in life science cleanrooms.”

Monday, April 9, 2012

Rapid Detection of Resistant Tuberculosis, Other Pathogens on the Horizon

For patients with infectious diseases liketuberculosis, timing is critical. Tuberculosis is one of the most common causes of death from a curable disease, and cases of drug-resistant tuberculosis are on the rise. But determining if a patient carries an antibiotic-resistant strain can take weeks or months using current clinical diagnostics.

During this period, patients are often treated with ineffective drugs and can continue to spread their illness as time slips away. This problem is not unique to tuberculosis – quicker diagnostics are urgently needed for all infectious diseases.

Deborah Hung, a core faculty member of the Broad Institute, an infectious disease physician, a bacterial geneticist and chemical biologist, sees faster diagnosis and identification of resistance as a critical need and a solvable problem. “There’s no excuse for our not solving this,” said Hung, who is also the co-director of the Broad Institute’s Infectious Disease Program and an assistant professor at Harvard Medical School and Massachusetts General Hospital. “It sounds so obvious: the correct antibiotic earlier, even hours earlier in some cases, saves lives. Why don’t we have the information that we need, to know what antibiotic we can use, sooner? There’s really no excuse in this day and age.”

The standard way of determining antibiotic resistance is to see if bacteria will grow on a cell culture dish (shown here) in the presence of an antibiotic. But long before growth is inhibited, changes are happening within sensitive bacteria. Researchers have developed a new technique to rapidly identify a wide range of pathogens and determine antibiotic susceptibility. Image created by Lauren Solomon, photo courtesy of the CDC and istockphoto/© Karen Mower.

Hung and her colleagues have been working to tackle this problem using a new approach that may represent a shift in diagnostic thinking. In a paper appearing this week in the journal Proceedings of the National Academy of Sciences, they present results indicating that it may be possible to rapidly diagnose patients and determine antibiotic resistance or susceptibility. The strategy could be applied to not only tuberculosis, but also a wide range of pathogens, including other bacterial species as well as viruses and fungi.

Currently, diagnosing infections usually involves culturing the agent from patient samples, and then carrying out a collection of other assays to determine its precise identity. Andrew Onderdonk, director of the clinical microbiology laboratory at Brigham and Women’s Hospital and an author of the paper, sees having a fast way to both identify pathogens and determine resistance as a critical piece now missing in the clinic.

“Not having a way to rapidly determine what antibiotics are going to work against a particular organism has been a real impediment,” he said. “It doesn’t do a lot of good for me to be able to tell a physician quickly that a patient has a certain bacterial infection when I can’t tell them what drugs to use against it.”

Today, the standard way of determining antibiotic resistance is to see if bacteria will grow on a cell culture dish in the presence of an antibiotic. But long before growth is inhibited, changes are happening within sensitive bacteria. These vulnerable bacteria will respond to a drug by turning up and down certain genes, changing their transcriptional programming as the drug effectively blocks cellular processes and causes stress to the bacteria. These changes can be seen in their RNA transcripts – read outs of what genes are on and off at a certain point in time.

“Antibiotics have an unseen effect on bacteria in a matter of hours, even minutes in many cases,” said James Gomez, a co-first author of the PNAS paper and a research scientist in the Broad Institute’s Infectious Disease Program. “This means that RNA transcriptional signatures are going to be a super fast way to tell if bacteria are reacting to antibiotic treatment.”

The new technique has many applications, but may be especially pertinent to improving the speed of diagnosis and treatment for patients with diseases like tuberculosis. Compared to other bacteria,tuberculosis grows very slowly in the lab, meaning that it can take weeks to conclusively determine susceptibility using standard techniques. The researchers’ RNA-based approach could drastically reduce the time it takes to find these answers.

“Tuberculosis, especially drug-resistant tuberculosis, is a serious global threat,” said Eric Lander, director of the Broad Institute. “Deb Hung and her team have devised a tremendously innovative way to address the critical need to detect drug resistance in hours not weeks.”

Other researchers have developed DNA-based strategies to detect bacteria and determine antibioticresistance, looking for specific genes or mutations known to confer resistance. “Such methods are limited by our current state of knowledge,” said Gomez. “You have to already know what all the underlying mutations are and we simply don’t know in many cases. Here, we’re directly measuring whether the bacteria are responding to an antibiotic.”

“Diagnostics in infectious disease is a solvable problem, but it requires creativity and commitment, and a willingness to think beyond the status quo,” said Hung, referring to current diagnosticmeasures that rely on waiting for bacteria to live or die on in a cell culture. “It’s a shift in mindset to say, looking at expression signatures is good enough to predict if a bacterial cell is fated to death without literally having to document that it’s died.”

The RNA-based technique will need to be tested more widely and applied to clinical samples for validation. So far, the researchers have tested the technique on clinical urine samples, detecting three strains of bacteria that can cause urinary tract infections and determining which strains wereantibiotic-resistant. They have also used clinical isolates and lab isolates of tuberculosis to measure transcriptional responses to antibiotics, but the real test will come when the researchers make such measurements in sputum samples collected directly from patients.

Although much work lies ahead in testing the technique and in developing and adapting the technology that empowers it for the clinic, Onderdonk sees the new approach as potentially transformative for many infectious diseases. “This is a technology with potentially huge applications in clinical microbiology,” he said. “I’ve been waiting for something like this to come along for twenty years.”

Many factors will need to come together to drive the project forward and bring such techniques to the clinic. “To get somewhere with this diagnostic or any other fundamentally new approach is going to require an incredible, interdisciplinary effort,” Hung said. “Detection requires microbiological expertise, but it also requires people with different backgrounds and knowledge, from genomics and bioinformatics to engineering, to come together. We cannot forever diagnose infection and antibioticsusceptibility the way that we currently do. It’s simply not good enough; it simply is not fast enough.”

Other researchers who contributed to this work include co-first author Amy Barczak along with Benjamin Kaufmann, Ella Hinson, Lisa Cosimi, Mark Borowsky, Sarah Stanley, Devinder Kaur, Kevin Bryant, David Knipe, and Alexander Sloutsky.

Paper(s) cited: Barczak AK et al. “RNA signatures allow rapid identification of pathogens and antibioticsusceptibilities.” Proceedings of the National Academy of Sciences DOI: 10.1073/pnas.1119540109

Wednesday, April 4, 2012

Our Latest Newsletter is Now Available

Our April newsletter is now available. In this issue, we describe a novel optofluidic technology that may be used in a new class of biomedical diagnostic devices, and present an interesting report on popcorn-shaped gold nanoparticles being used to rapidly detect Salmonella MDR strains.

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An Innovation State of Mind

Water - the most recognizable chemical formula in the world. This vital substance covers over 70% of the Earth's surface and has from the genesis of time sustained all life. Our civilization largely depends on our ability to do three things to water; move it, measure it and treat it.

Early man's use of a ladle to transport water to his mouth, perform a sniff-test to ensure quality, progressed through the ages to Greek innovators like Archimedes' design of a screw pump and Hippocrates' cloth bag filter around 500 B.C. Further technology advancements came with the discovery of microorganisms in the late 17th century and chlorination in the 19th century.

Our ability to sustain large populations is inextricably linked to our ability to farm intensively. With agriculture today consuming 70% of fresh water supplies, it has been argued that today's food production can largely be seen as a global trade in water.

Discussions on the relationship between water and energy, known as the water-energy nexus, are increasingly being held. Escalating energy costs act as a market driver to water equipment manufacturers, who fight to become known as the greenest supplier.

Likewise energy providers understand the cost of water use in their production.
In addition to the relationship between water and energy, we see a strong relationship between water and technology – a water-energy-technology nexus. Today's advanced water treatment technologies are helping to create more and more advanced materials, this in turn is helping to create more advanced treatment technologies. In the very near future we can see nanotechnology and semi-conductors (in the form of UV-LEDs) playing an increased role in water treatment. Add to that major advances in rapid microbiological analysis driven by photonics and microprocessor developments, and the relationship becomes clearer.

The challenge then becomes how do we embrace these relationships to help solve problems? Whether the advances lay in improved access to clean water and sanitation in the developing world, or in resolving hot button issues like the spread of invasive species through ballast water, we should look to industries that have a track record of innovation to draw on their success.

Google's use of sea water in Finland to cool their massive servers, or the rapid proliferation of horizontal fracturing in natural gas production represent both innovative advances and market opportunities. Too often we limit progress through fear of new technology adoption.

We need researchers, thought leaders and business executives who understand these relationships and have the courage to deploy resources to accelerate change. Some of these people will gather at an upcoming WWEMA Washington Forum in D.C. in April where these and other issues will be discussed. We should not shrink from the challenges facing us, or suppress innovations solely for the sake of profits; we should present them to the world.

The progress of civilization can be linked to our skill at moving, measuring and treating water. However, our industry competes with many others for the brightest minds. Unemployment amongst engineers is less than half the national average and higher education is not keeping pace with the demand.

H2O is universally understood as the foundation of life, so let's work together to recognize our water-innovators and give room to those who will carry us forward to a secure future.

Story adapted from

Graphene Nanosensor Tattoo on Teeth Monitors Bacteria in Your Mouth

Detection of very small amounts of a chemical contaminant, virus or bacteria in food systems is an important potential application of nanotechnology. The exciting possibility of combining biology and nanoscale technology into sensors holds the potential of increased sensitivity and therefore a significantly reduced response-time to sense potential problems.

Bacterial contamination in general, is a major problem affecting both developing and developed countries and the rapid and sensitive detection of pathogenic bacteria at the point of care is extremely important; especially given that more and more pathogens are becoming immune to antibiotics (DARPA even seeks to replace antibiotics with rapidly adaptable nanotherapeutics).

Early detection of pathogenic bacteria is critical to prevent disease outbreaks and preserve public health. This has led to urgent demands to develop highly efficient strategies for isolating and detecting this microorganism in connection to food safety, medical diagnostics, water quality, and counter-terrorism.

Limitations of most of the conventional diagnostic methods are the lack of ultrasensitivity and the delays in getting results. One problem is that many infectious agents have very low minimum infective doses, requiring detection mechanisms that offer extremely high sensitivities. Another problem is the time delay between taking samples and getting the results: Current methods for the detection of pathogenic contaminants involve the collection and pre-processing of analyte samples – biological specimen, food samples etc. – and then performing laboratory-based assays. It will be extremely advantageous to have sensing systems that can be directly integrated with the sources of contamination or points of infection to provide an in situ monitoring/detection bacterial presence.

A team of scientists, led by Fiorenzo Omenetto at Tufts University and Michael C. McAlpine at Princeton University, have now developed a novel approach to interfacing passive, wireless graphene nanosensors onto biomaterials via silk bioresorption. They have reported their finding in the March 27, 2012 online edition of Nature Communications ("Graphene-based wireless bacteria detection on tooth enamel").

"Graphene is capable of highly sensitive analyte detection," says Manu S. Mannoor, a graduate student in McAlpine's group and the paper's first author. "In our paper, we demonstrate that graphene can be printed onto water-soluble silk. This in turn permits intimate biotransfer and direct interfacing of graphene nanosensors with a variety of substrates including biological tissues and hospital IV bags to provide in situ monitoring and detection of bacterial contamination and infection."

The nanoscale nature of graphene allows for high adhesive conformality after biotransfer and highly sensitive detection. The team demonstrates their nanosensor by attaching it to a tooth for battery-free, remote monitoring of respiration and bacteria detection in saliva.

Such an approach of direct interfacing of nanosensors onto biomaterials could revolutionize areas ranging from health quality monitoring to adaptive threat detection.

Mannoor explains the fabrication technique to Nanowerk: "First, we printed graphene nanosensors onto water-soluble silk thin-film substrates. The graphene is then contacted by interdigitated electrodes, which are simultaneously patterned with an inductive coil antenna. Finally, the graphene/electrode/silk hybrid structure is transferred to biomaterials such as tooth enamel or tissue, followed by functionalization with bifunctional graphene–AMP biorecognition moeities."

Silk thin-films serve as an ideal 'temporary tattoo' platform owing to their optical transparency, mechanical robustness, biotransferability, flexibility and biocompatibility. Omenetto's research group has been conducting research with silk composite materials for biosensing applications for a while now and has already reported a promising path towards the development of a new class of metamaterial-inspired implantable biosensors and biodetectors (see "Implantable silk metamaterials could advance biomedicine, biosensing").

The resulting device architecture is capable of extremely sensitive chemical and biological sensing, with detection limits down to a single bacterium, while also wirelessly achieving remote powering and readout. Potential applications for this kind of 'biotransferrable' sensors could include on-body health quality monitoring, hospital sanitation monitoring, and food safety analysis and may provide a first line of defence against pathogenic threats at the point of contamination.

"What we were able to demonstrate is only a prototype, 'first generation' platform that served as a proof of concept for the in situ bacterial contamination monitoring by direct interfacing of graphene nanosensors with a variety of substrates including biological tissues," says Mannoor. "Future challenges include mainly improving the selectivity of the detection system to be able to distinguish between various species of pathogenic bacteria. Reducing the sensor form factor is also another challenge facing the future development of the sensor."

Story adapted from Click on the image to see a larger picture of the graphene wireless sensor biotransferred onto the surface of a tooth. (Image: McAlpine Group, Princeton University).