Particle Measuring Systems Introduces a Real-Time Microbial Monitor

Particle Measuring Systems introduced their innovative instrument, the BioLaz™ Real-Time Microbial Monitor for rapid detection of airborne biological organisms in controlled environments. The BioLaz™ Real-Time Microbial Monitor offers immediate notification when biological particles are present and real-time verification of biological activity levels during filling operations. This results in faster batch releases, revolutionizing sterile manufacturing processes.

As process air passes through the system, the BioLaz™ Real-Time Microbial Monitor illuminates particles in the sample. If biological particles are present, the organisms fluoresce and are counted in real-time. This system can easily be integrated into new or existing facility monitoring systems and reduces operator errors inherent when standard growth-media methods are employed.

The BioLaz™ Real-Time Microbial Monitor has been independently tested to meet the rigorous requirements of USP Validation of Alternative Microbial Methods and of EP 5.1.6 Alternative Methods for Control of Microbiological Quality. Additional features include an internal pump, which eliminates the cost and need for an external vacuum system, and a small footprint in a 316L stainless steel enclosure.

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bioMerieux and Biocartis Sign Strategic Partnership in Molecular Diagnostics

bioMerieux and Biocartis announced today that they have entered into a strategic agreement to co-develop assays on Biocartis' fully integrated molecular diagnostics system, which the two companies will co-distribute starting in 2012. Biocartis has continued to successfully develop its molecular diagnostics platform, which was acquired from Philips earlier this year. The platform now fully integrates all the steps of a multiplexed molecular assay, from sample-in to data-out, in a sealed disposable cartridge, which avoids any contamination risk. Providing rapid results, the system is able to perform complex tests on a wide variety of samples, including oncology assays on tissue. The Biocartis platform does not require molecular biology experience or infrastructure with highly skilled technicians, and involves only 1-2 minutes hands-on time. bioMerieux will enhance the Biocartis platform's broad menu with an exclusive line of tests for healthcare-associated infections and sepsis. bioMerieux also plans to develop oncology and theranostics assays on the system.

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Free Trial Offer: ampliPHOX Colorimetric Detection Technology for Low-Density Microarrays

InDevR, developer of advanced life science products, announced that it is seeking scientists interested in participating in extensive beta site testing of its ampliPHOX Colorimetric Detection Technology for low density microarrays. Based on the overwhelming success of initial beta site testing, InDevR plans to significantly expand testing by offering a free trial kit (instrument and reagents) to scientists currently working with low density microarrays or assays that utilize biotinylated targets immobilized on transparent substrates.

InDevR's ampliPHOX detection technology is an innovative new colorimetric detection method based on light-initiated signal amplification through polymerization. The field portable and inexpensive ampliPHOX Reader both initiates the signal amplification process and collects a digital image of the result. In addition, the ampliVIEW software is capable of automatic image interpretation, providing the user with immediate results. The ampliPHOX technology is a rapid and inexpensive alternative to traditional fluorescence-based microarray detection methodologies.

"Early feedback from collaborators that have tried ampliPHOX has been enthusiastic -- they love the simplicity, sensitivity, and affordability of the system. We want to solicit broad-based feedback from the community by placing 50 trial kits with scientists looking for alternatives to more expensive or complicated detection technologies," said Dr. Kathy Rowlen, CEO of InDevR. Scientists interested in evaluating ampliPHOX detection should register for a free trial on the InDevR website.

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Lonza microCompass™ Molecular Assays on the BD Max™ System

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), and Lonza Group Ltd announced that they have entered into an exclusive licensing and collaboration agreement for Lonza to commercialize its microCompass™ molecular assays on the BD MAX™ System. Lonza has the exclusive worldwide license to co-market the BD MAX™ System with the complete microCompass™ product line in selected fields. The microCompass™ assays on the BD Max™ system will provide an automated platform with same day results for quality control testing in the Pharmaceutical and Personal Care Products market segments. BD and Lonza are also developing and optimizing automated rapid microbial testing solutions that are easy to use with true 'load and walk away' functionality.

The BD MAX™ System is based on microfluidics and molecular biology technologies, which fully automate nucleic acid extraction/recovery, polymerase chain reaction setup, amplification and detection. The microCompass™ assays will facilitate rapid detection for total bioburden load, sterility testing, Mycoplasma, and a variety of specific organisms. The microCompass™ reagents are designed to be flexible for ongoing assay development and menu expansion to meet global and manufacturing sites' unique needs. Combined, this novel system provides quality control personnel with a rapid and accurate testing solution. This contributes to improved control, quality and efficiency in the manufacturing and overall product release process within the Pharmaceutical and Personal Care markets.

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Microbial Assessment of Finished UHT and ESL Products Reduced to 36 Hours

Charm Sciences´ EPIC system provides rapid microbial assessment of finished UHT and ESL dairy and dairy substitute products. Recent advances have reduced the incubation time from 48 to 36 hours for most products. The EPIC (End Product Indicator Charm) system´s faster 36-hour incubation helps manufacturers remediate possible contamination concerns, reduce process line down time and release safe product more quickly.

"EPIC is being used by manufactures of dairy products, soy milk, rice milk, almond milk, soups, broths, and nutraceutical beverages around the world," said Donna Stearns, EPIC Product Manager at Charm. "We are excited to provide current and new customers with a faster test which can enhance food safety, and help manufactures increase operational efficiencies and reduce warehouse costs." EPIC provides a sensitive presence/absence test for microbial ATP, a bio-marker of microbiological quality. Test results are captured and stored in real-time with EPICLink software allowing for further trend analysis.

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FDA Announces Plan to Launch "Regulatory Science" Initiative

The Food and Drug Administration (FDA) has issued a report titled “Advancing Regulatory Science for Public Health,” that outlines the agency’s plan to develop new scientific and technological tools, standards and approaches to improve its ability to assess the safety, efficacy, quality, and performance of FDA-regulated products, including foods and tobacco. FDA expects to use President Barack Obama’s $25-million increased budget request for fiscal year 2011 to expand the initiative and “build additional partnerships with academia, industry and government around the country.” According to a news source, FDA’s budget has been frozen under a continuing resolution Congress passed before taking its latest recess.

A new office dedicated to regulatory science will be created, and the initiative’s goals include protecting the food supply by focusing on “the development of more rapid and practical methods for detecting microbial pathogens in food and equipping FDA’s labs to test multiple food samples for contaminants at once. In addition, FDA must enhance the scientific understanding of the causes of food-borne illness so that feasible interventions can be designed and implemented to effectively reduce risk.” The report refers to other opportunities “to advance regulatory science to improve food safety,” such as (i) “Developing effective tools and strategies for sampling, testing and analysis,” (ii) “Tracking Salmonella in the food supply,” (iii) “Preventing microbiological hazards,” (iv) “Responding to food-borne illness,” (v) “Controlling toxins,” and (vi) “Monitoring antibiotic resistance in food-borne pathogens.”

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New Market Report States RMM Usage in the Pharma and PCP Sectors Will Double

Strategic Consulting, Inc.
318 Prosper Road
Woodstock, NY 05091
phone: +1 802-457-9933
mobile: +1 802-291-0134
email: weschler@strategic-consult.com
website: www.strategic-consult.com


According to a new market research report from Strategic Consulting, Inc., the global Pharmaceutical (Pharma) and Personal Care Products (PCP) Sectors conducted more than 530 million microbiology tests last year, which resulted in a market value of over $1.8 billion for these tests.

Pharma/PCP—2nd Edition is a follow-on report to the original report published in 2004. As with the first edition, this new report provides detailed information about testing practices for both of these Sectors covering:

• What type of samples are collected
• Which organisms are tested
• A review of the methods used for analysis
• Current and projected microbiology testing volumes and market values based on existing and potential new technologies are also provided

A key aspect of this Report is the spotlight on the utilization of rapid microbiological methods (RMMs) in each of these Sectors. The PCP Sector has been more aggressive with the adoption/usage of RMMs and this should continue over the next five years. The Pharma Sector, while using more than in the past, lags be-hind the PCP Sector in RMM test volumes. The Report thoroughly examines the similarities and differences related to RMM utilization today and projects these patterns forward for five years. In addition, testing patterns and approaches within subsets of each of these Sectors are discussed. The Report examines differences between classic Pharma and Biopharma company approaches to RMMs as well as global PCP companies in comparison to regional and contract manufacturer PCP companies.

The Report is based on two primary market research efforts:

• Extensive telephone interviews with Pharma and PCP plant QA/QC personnel
• In-depth interviews with key opinion leaders and senior/leading quality experts/management (collectively referred to as KOLs) from the Pharma and PCP Sectors

In the interviews with the KOLs, the following topics were thoroughly explored:

• Do you use rapid tests/systems? If so, where and why?
• Do current RMMs meet your needs?
• What improvements would you like to see?
• Would these improvements broaden RMM use?
• Is there a clear best RMM system out there now?
• What are the key organisms and applications for rapid?
• What are the hurdles for RMM adoption at your company?
• What are your predictions for RMMs over the next 5 years?

These KOLs provided a rich and personal understanding of their own experiences with RMMs. In some cases the KOLs are thoroughly pleased with their accomplishments and see broader usage in their Sector. In other cases, the KOLs recognize and speak to the mismatch between technology and their needs. The KOLs also provide candid comments about current RMMs.

In addition, the Report provides business summaries of 15 diagnostic companies involved with RMMs for the Pharma and PCP Sectors. Included in these summaries are insightful comments by the KOLs regarding their experiences with these products and companies.

Pharma/PCP—2nd Edition thoroughly reviews current testing practices in these two Sectors. A fundamental conclusion is that RMM usage is expected to continue to grow as current applications make further penetration and as new applications are added:

• Pharma and PCP Sectors conduct an extensive amount of testing and are #2 and #3 Sectors based on test volumes in the industrial market (Food being #1)
• Testing and market value is growing....driven by regulations and protection of brand names
• There have been recalls impacting key players in these sectors, which only heightens testing
• The use of RMMs is increasing steadily in each Sector but there are major differences regarding adoption patterns and uses
• In 5 years, RMM usage is expected to more than double but this could be impacted on the upside significantly if new technologies have a better fit, and more versatility.

For further information on the Pharma/PCP—2nd Edition Report please contact Tom Weschler at Strategic Consulting, Inc. by phone (802-457-9933), email (weschler@strategic-consult.com), or by visiting their website at www.strategic-consult.com.

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Pall Corporation’s New GeneDisc® Rapid Microbiology System Advances Quality Assurance Analysis

Pall Corporation
25 Harbor Park Drive
Port Washington, New York 11050
toll free phone: 1-800-521-1520
fax: 516-801-9754
email: genedisc@pall.com
website: http://www.pall.com/biopharm_53215.asp

Pall Corporation, a global leader in filtration, separation and purification, today announced the introduction of the GeneDisc® Rapid Microbiology System for advanced microbial quality monitoring. This system represents Pall’s latest quality assurance innovation for the pharmaceutical manufacturing industry.


“The GeneDisc Rapid Microbiology System represents a leap forward for applications of rapid microbiological analysis in the pharmaceutical manufacturing setting,” says Ken Frank, President of Pall Life Sciences Biopharmaceuticals division. “This reliable, simple to use, and robust platform represents a significant time savings over traditional incubation sampling methods and can allow materials and final products to be released more quickly, improving production efficiency and reducing inventories.”

Typical culture-based methods may need at least five days to produce results. Pall’s GeneDisc System generates comparable results for most microbiological applications in just a few hours. The advantage provided by the GeneDisc System shortens the manufacturing cycle for pharmaceutical manufacturers, reducing warehousing costs, improving product time to market, and increasing ROI throughout the production process. The GeneDisc Rapid Microbiology System represents Pall’s first step in providing a complete qPCR platform for rapid microbiology analysis.

The GeneDisc Rapid Microbiology System is efficient and easy to use. Its novel, highly simplified technology, based on bar-coded data input and fewer operator-dependent steps, ensures reliable results that significantly reduce the risk of user error. The economic design of the GeneDisc System also offers the unique advantage of moving assays to an operator with relatively modest training, freeing up technically skilled staff for more demanding duties.

This new application in Pall’s GeneDisc product group is based on established quantitative polymerase chain reaction (qPCR) technology, which provides a simple, rapid tool for microbiological analysis. This single-protocol solution yields highly reproducible results with simplicity, speed and security, enabling quality control testing to be executed on a much shorter timetable than by using traditional methods.

The first of these assays is a Specified Microorganism Test, which simultaneously detects indicator pathogens as required by Pharmacopeia. Results are obtained within hours and not the several days required by traditional microbiology methods. Additional assays are planned that will further expand the GeneDisc System to perform accelerated microbiological testing during various stages of pharmaceutical and biotech production.

“Typical methods of sample analysis often require three to five days to detect contamination,” says Dr. Peter Ball, Technical Marketing Director for Pall Life Sciences. “That can mean scrapped or reworked product, which represents considerable risk and cost. With the GeneDisc System, we can reliably eliminate those production risks in just a few hours,” Ball says.

Amelia G. Tait-Kamradt, a Scientist at Pfizer, Inc., will present, “Using a Novel qPCR Platform to Accelerate Pharmaceutical Microbiology Testing,” a whitepaper highlighting the advantages of the GeneDisc System at the Parenteral Drug Association’s 5th Annual Global Conference on Pharmaceutical Microbiology, October 26, in Washington, D.C. For more information on the GeneDisc Rapid Microbiology System or any of the other Pall Corporation life sciences solutions, visit www.pall.com/biopharm.

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