Thursday, June 24, 2010

Millipore Launches the New MilliPROBE® Detection System for Mycoplasma

Millipore Corporation
290 Concord Road
Billerica, Massachusetts 01821
phone: +1 978-715-4321

Millipore Corporation, a leading provider of technologies, tools and services for the global life science industry, announced the launch of a new product from its ground-breaking collaboration with Roka Bioscience to develop faster, more robust tests for contaminants in pharmaceutical and biotechnology manufacturing. The MilliPROBE® Detection System for Mycoplasma is the first solution of its kind for the early detection of Mycoplasma contamination in the highly regulated biopharmaceutical manufacturing industry.

"The launch of our new MilliPROBE System represents a breakthrough innovation and is the culmination of four years of collaborative work to change the way the industry tests for Mycoplasma," said Jean-Paul Mangeolle, President of Millipore's Bioprocess Division. "The system builds on Millipore’s strength in mycoplasma risk management. It integrates our industry-leading sample preparation technologies and testing expertise with core molecular diagnostics technologies developed by Gen-Probe, Incorporated (and recently licensed to Roka Bioscience), to deliver a unique solution that addresses an immediate and critical market need. We are extremely excited about the market opportunity for the MilliPROBE System."

Mycoplasma is a small, slow-growing and self-replicating bacteria that is extremely difficult to detect and eliminate from biopharmaceutical manufacturing processes. Mycoplasma contamination can have costly consequences for biopharmaceutical manufacturers, who must often destroy an entire drug batch and shut down production facilities for an extended period when Mycoplasma contamination is detected.

The MilliPROBE Detection System for Mycoplasma, the newest assay in Millipore’s MilliPROBE platform aimed at rapid microbial detection, cuts detection time from between 28 and 35 days (for traditional culture-based technology) to just four hours. Faster and more robust detection enables biopharmaceutical manufacturers to test more frequently and take corrective action earlier in the production process, reducing financial risks and optimizing product yields.

"The MilliPROBE system is unique because it can be operated by technicians with limited molecular training, while meeting the stringent requirements of the biopharmaceutical quality control lab," noted Roland Heinrich, Millipore Vice President, Process Monitoring. "It includes a novel Millipore sample preparation device designed to handle complex bioreactor samples in larger volumes than other mycoplasma testing products. It also includes Gen-Probe’s new Background Reduction Technology (the first of its kind), which protects the assay from contamination that can cause false positive results - a prevalent testing problem representing substantial financial risk for customers."

"We will continue to leverage our ongoing partnership with Roka Biosciences to introduce additional MilliPROBE assays in the future," Heinrich added.

In 2005, Millipore and Gen-Probe, based in San Diego, California, formed an exclusive partnership to develop faster, more reliable and sensitive tests for contaminants commonly found in pharmaceutical and biotechnology manufacturing processes. In September, 2009, Millipore transferred its collaboration to Roka Bioscience, an independent company created through the spin-off of Gen-Probe’s industrial assets.

Millipore Launches the New Milliflex® Quantum Rapid Microbial Detection System

Millipore Corporation
290 Concord Road
Billerica, Massachusetts 01821
phone: +1 978-715-4321

Millipore Corporation, a leading provider of technologies, tools and services for the global life science industry, announced the launch of its new Milliflex® Quantum rapid microbial detection system. The system enables drug and vaccine manufacturers to respond to microorganism contamination earlier in the production process.

"The Milliflex Quantum system provides results faster than traditional testing methods. It is designed to significantly improve product quality management, helping customers to release product to the market sooner and avoid line shutdowns," said Roland Heinrich, Ph.D., Vice President for Process Monitoring in Millipore’s Bioprocess Division.

"The system is based on two widely adopted technologies – membrane filtration, performed with proven Milliflex membrane filtration devices, and fluorescent staining – to ensure consistent, reliable results," Heinrich continued. "In addition, the validation process is streamlined because it involves only minimal changes to the compendial tests currently used."

The Milliflex Quantum system is ideal for testing raw material, in-process samples, final product and environmental samples. It is non-destructive, an important feature that enables operators to grow microorganisms in order to identify them with standard ID technology. The majority of rapid test systems are destructive in nature, which means they offer limited capabilities for microorganism investigation and identification.

The Milliflex Quantum system consists of a reader, camera and fluorescent reagents used in combination with the Milliflex PLUS pump, Milliflex filtration devices and media cassettes. It is compact and easy to learn, for smooth integration into an existing laboratory set-up. Millipore offers a comprehensive range of services to support the system’s implementation, including installation, operational and performance qualification guidelines.

"This innovative new system extends Millipore's rapid microbial detection portfolio, which includes the recently launched MilliPROBE® detection system for mycoplasma," Heinrich noted. "The simple two- to three-step method ensures accurate microbiological results, while reducing overall time to result."

Tuesday, June 22, 2010

InDevR Announces the Availability of Their Virus Counter for Rapid Virus Quantification

InDevR (Boulder, Colorado) announced the availability of the Virus Counter for rapid virus quantification. The Virus Counter is a unique bio-analytical tool that enables scientists to measure virus particle concentration within minutes. Unlike conventional plaque titer assays, which take days to complete, the Virus Counter provides accurate virus quantification in less than 10 minutes. The unprecedented efficiency and accuracy of virus quantification with the Virus Counter is anticipated to dramatically accelerate vaccine and antiviral therapeutic research and development. The Virus Counter represents the next generation of compact “personal” flow cytometers designed for a specific application. The Virus Counter works for both RNA and DNA viruses and researchers will find that the instrument assay is fast, cost-effective, and easy to use. For purified viruses, the assay involves a simple staining step followed by a 5- to 10-minute analysis on the Virus Counter. Virus Counter InCyt software is intuitive and features real-time data analysis that further reduces the time-to-results.

Micro Identification Technologies and OSI to Manufacture the MIT 1000 Light Scattering Microbial Identification System

Micro Identification Technologies, Inc. (MIT) announced that it has signed an Agreement with OSI Optoelectronics (OSIO), a subsidiary of OSI Systems to manufacture its microbial rapid identification system, the MIT 1000. The MIT 1000 is a laser-based, microbial rapid identification system capable of identifying 23 different species of pathogenic bacteria just minutes after culturing. Due to the small sample volume required, culture time is also reduced by up to 50% compared to standard testing procedures. In most cases, results can be obtained in as little as eight hours from the time the culturing process begins. The device uses the principles of light scattering to discriminate various bacteria cells that are suspended in filtered water. Incident laser light both reflects off the bacteria’s outer surface and penetrates the body of the bacterium, the light interacts with any structural features and eventually emerges from inside the cell. These light patterns are unique for each species and thereby create a signature that is captured and stored in a computer data base. The MIT 1000 features 35 photo detectors that surround the sample vial and collect light scattering intensities that are generated when a cell intersects the laser beam. Identification occurs when 10-50 organisms are analyzed, and typically takes less than 10 minutes.

Shimadzu and bioMérieux to Develop Mass Spectrometry System for Microbial Identification

Shimadzu and bioMérieux announced that they have entered into a partnership to commercialize a mass spectrometry system for bacterial identification. bioMérieux will work with Shimadzu and their subsidiary, Kratos Analytical, to adapt their linear MALDI-TOF mass spectrometry technology for optimized integration into the microbiology laboratory workflow. This new solution is planned for commercialization by bioMérieux in 2010, together with the microbial database acquired from AnagnosTec.

Rapid Micro Biosystems Releases Service Pack 2 Software for Growth Direct™

Rapid Micro Biosystems announced the availability of Service Pack 2 software for the Growth Direct™ System. The new release includes both user and industry driven product features that enable Quality Control labs to improve their performance by optimizing workflow and eliminating waste. These capabilities will drive the transformation from manual quality control to an automated, paperless laboratory. New alerting features let the business respond faster to key quality events, such as the early warning of contaminated product samples, improving efficiency, speeding corrective actions and preventing product loss. The paperless QC lab is enabled through seamless LIMS connectivity that automates results recording, data management and reporting, a common source of errors. The system automatically archives results and history, integral to regulatory compliance and critical for traceability and audit-ability. Additionally, custom reporting allows users to tailor reports specific to their laboratory and business needs.

bioMérieux’s TEMPO® STA Assay Gains International Approvals for Food Safety Testing

bioMérieux (Marcy L’Etoile, France) announced that the TEMPO® STA, an automated quality indicator test for the fast enumeration of Staphylococcus aureus in food products, has been approved by both the AFNOR Validation according to the ISO 16140 norm, and the AOAC Research Institute. TEMPO STA provides results in 24 hours without any need for confirmatory testing, compared to traditional methods, which take anywhere from 48 hours to 4 days for results.

Thursday, June 17, 2010

Celsis Hosts User Group Meeting for its European Pharmaceutical Customers

Celsis International Ltd. hosted the first user group meeting for customers in the pharmaceutical industry at its offices in Brussels, Belgium. The full-day meeting included presentations from two of Celsis’ pharmaceutical customers, representing Janssen Pharmaceutica and Schering-Plough (Merck), who both discussed and answered questions about their experiences using the Celsis Advance™ system. Attendees also benefited from presentations covering topics from the European Medicines Agency (EMA) validation pathways to available regulatory tools, as well as a scientific presentation on rapid sterility testing using the Celsis AKuScreen™ system. "We presented a case study about our experiences in validating and implementing a rapid microbial method. For the user group, we described the benefits we have received by introducing Celsis Rapid Detection products - specifically in achieving shorter cycle times," said Miek Van Loon, Janssen Pharmaceutica. Dr. Geert Verdonk, of Schering-Plough (Merck) stated that they "discussed and provided information proving that a statistical model is suitable for the implementation and validation of new technologies."