• Quality Systems International Announces LIMSMaps for WinLIMS.NET• Thermo Fisher Scientific Implements Enterprise-Level LIMS for Northern Ireland Water
• Accelerated Technology Laboratories Establishes Partnership with Brady Corporation
• New Literature Available for Autoscribe's Biobank and Biorepository Management Software
• Agilent Technologies Upgrades ICP-MS Software, Expands ICP-MS Instrument Family
• Bruker Rings NASDAQ Opening Bell on Company's 50th Anniversary
• FDA to Tackle Industry Concerns in First Biosimilars Meeting
• FDA Unveils New Office of Science and Innovation
• FDA Wants Companies, Agency to Take Bigger Steps Abroad
• FDA Could Give New Guidance on Nanotechnology
• Drug Labeling Changes Come Into Effect in October
• FDA Draft Guidance Harmonizes Regional Powder Density Texts
• FDA Commissioner Says Agency Needs More Authority
Quality Systems International Announces LIMSMaps for WinLIMS.NET
Quality Systems International Corporation has released LIMSMaps for WinLIMS.NET. This new software module integrates sampling location coordinates with other collected data to provide an informative and useful visual tool for recording, analyzing and interpreting the LIMS data using a standard, intuitive interface. LIMSMaps for WinLIMS.NET can be used to simplify sample login, schedule sampling pick-up run, and to quickly access information for sampling sites. WinLIMS.NET, now configured and optimized for use with portable computing technologies like the iPad, gives users a complete mobile LIMS solution for conveniently logging and accessing data directly through their mobile computing devices. With the addition of LIMSMaps for WinLIMS.NET users can ensure their data is tagged with precise geographic coordinates.. For details, visit http://www.qsius.com.
Thermo Fisher Scientific Implements Enterprise-Level LIMS for Northern Ireland Water
Maquet SA Adopts Agilent Electronic Lab Notebook Paired with Surety Intellectual Property Integrity Protection
Thermo Fisher Scientific Inc. has announced that Northern Ireland Water (NI Water), the sole provider of water and sewerage services in Northern Ireland, has standardized on Thermo Scientific SampleManager LIMS across its laboratories as part of its continuous focus on improving sample management and maintaining the highest quality water. SampleManager LIMS is used to manage more than 150,000 samples per year taken from reservoirs, water treatment works and directly from the taps in consumers' homes. NI Water's state-of-the-art laboratories carry out the necessary testing to ensure that drinking water is safe for consumption and meets all regulatory and quality standards. To enhance the quality of the test methods and to reduce time associated with collecting and logging field samples, NI Water has integrated a new handheld remote sampler with SampleManager LIMS. This allows field samples to be taken, results recorded and input directly into the LIMS, saving time, ensuring the quality of the sample at log-in, and reducing manual transcription errors as well as providing a secure record of sampler locations. Remote Sampler, developed by CSols, is already in pilot usage with customers across Europe and in UK-based water companies, who are using Remote Sampler with existing SampleManager LIMS installations. The introduction of Remote Sampler at NI Water extends the use of SampleManager LIMS to field applications, thus allowing more samples to be processed by in-the-field sampling. Because Remote Sampler reduces the time necessary to collect and log-in a sample, it enables more efficient use of laboratory resources, as well as consistent compliance with various regulatory requirements for documented processes, such as those defined by the Drinking Water Inspectorate (DWI) for the Water Industry. NI Water is a Government Owned Company (GoCo) set up in April 2007 to provide the water and sewerage services in Northern Ireland. It supplies 625 million liters of clean water every day for nearly 1.7 million people and treats 134 million m3 of wastewater each year. NI Water has equipped its laboratories with the technologies and infrastructure that allow it to deliver the highest quality water which consistently meets all regulatory and quality standards for consumption. SampleManager LIMS integrated with Remote Sampler has improved the efficiency and security of data entry as samples are taken in the various field locations, and greatly assisted sample identification and tracking. As all samples are now recorded on a single electronic database, the integrated solution has provided NI Water with a means to retrieve and report data in a way that would not have been previously possible, while also ensuring the integrity of the field samples at log-in. For details, visit http://www.thermoscientific.com/informatics.
Agilent Technologies Inc. and Surety, LLC, have announced that Maquet SA of Ardon, France, has purchased the Agilent OpenLAB ELN electronic lab notebook bundled with Surety’s AbsoluteProof third-party, digital time-stamping service. The combined solution bolsters Maquet’s long-term ability to protect and legally defend the authenticity and ownership of its scientific intellectual property (IP). Maquet, a major manufacturer of medical products, therapies and services for operating rooms and intensive care units, purchased the system to replace paper lab notebooks. To protect scientific intellectual property, Maquet personnel were regularly shuttling the notebooks to an off-site notary office to be manually time stamped. By implementing an automated digital notarization process, Maquet expects to streamline the efficiency and effectiveness of this process. The company says it was also seeking a tool to facilitate collaboration between research teams in France and Germany. “OpenLAB ELN enables our customers to capture, manage and share their valuable research,” said Bruce von Herrmann, vice president and general manager, Agilent Software and Informatics. “The seamless integration of AbsoluteProof secures corporate intellectual property at the time of inception, automating the documentation of when patents are submitted.” Agilent OpenLAB ELN provides scientists with a scalable, integrated platform for creating, capturing, managing and sharing information in an increasingly complex global environment. The open-architecture, customizable solution facilitates multi-discipline interaction, simplifies and accelerates R&D discovery, and streamlines data management. OpenLAB ELN v4.1 introduces experimental templates, enabling scientists to customize the view the experimental desktop. Agilent also has streamlined the analytical request workflow by reducing the number of steps between request and result, which dramatically improves lab productivity. A specific analytical module for documenting analytical methods, generating sequence files and capturing results has been added to facilitate report creation across one or more samples and techniques. AbsoluteProof digitally time stamps research data flowing within the OpenLAB ELN, providing substantial evidentiary support should the authenticity or ownership of time-stamped records be legally challenged. A secure digital time stamp (i.e., trusted time stamp) verifiably seals a record, enabling its time and content integrity to be independently proven at any time. Additionally, researcher identity is captured and sealed alongside the content during the collaboration workflow, increasing the defensibility of the overall “sign and witness” process. No other commercially available ELN offers such long-term, scientific intellectual property protection.
For details, visit http://www.agilent.com or http://www.surety.com.Accelerated Technology Laboratories Establishes Partnership with Brady Corporation
Accelerated Technology Laboratories, Inc. (ATL), a leading supplier of Laboratory Information Management Systems (LIMS), has announced that Brady Corporation - North America will offer ATL's customers high quality printers and scanners in conjunction with ATL's 2D Barcode Package. ATL has provided LIMS solutions for a number of industry segments including environmental, water/wastewater, commercial testing, food and beverage, mining, biotechnology, industrial hygiene, agriculture, public health and several other markets. ATL's Vice President of Sales and Marketing, Dr. Christine Paszko commented, "We are very excited by the opportunity created by this partnership. Brady North America brings high quality components for 2D Barcoding which complement ATL's cutting edge LIMS and Laboratory Automation Solutions." Founded in 1914, Brady Corporation offers a vast product offering which includes high-performance labels and signs, safety devices, printing systems and software, and precision die-cut materials. Brady corporate headquarters is located in Milwaukee and employs more than 7,000 people at operations in the Americas, Europe and Asia/Pacific. In regards to their partnership with ATL, Brady Corporation states, "For laboratories, it's all about ease of integration and information accuracy. We believe the partnership between Brady and ATL will provide exactly that: a hassle-free, reliable solution for implementing specimen identification." For details, visit http://www.atlab.com.
New Literature Available for Autoscribe's Biobank and Biorepository Management Software
Autoscribe has released a new brochure describing the use of their highly configurable Matrix Tracker software for biobank and biorepository applications. The software can be used to help track and trace the ever increasing number of bio-specimens (tissue, fluids, DNA samples, slides etc.) stored in bio-banks and bio-repositories. The management of sample repositories and biobanks is one of the most important issues currently facing pharmaceutical and biotechnology companies and research organizations. It requires the registration of samples as collected and tracking of their location at all times including recording a chain-of-custody. It may also include the allocation of studies to specific storage locations, the use of storage maps, the need for parent-child sample relationships, donor details with consent and ethical approval processing and much more. Autoscribe has implemented Matrix Tracker systems for customers including clinical research organizations and pharmaceutical companies. For details, visit http://www.autoscribelims.com/lims/sample-tracker.
Agilent Technologies Upgrades ICP-MS Software, Expands ICP-MS Instrument Family
Agilent Technologies, Inc. has released a new easy-to-learn version of its popular ICP-MS MassHunter Workstation software for the 7700 Series inductively coupled plasma mass spectrometer (ICP-MS). The company also expanded its ICP-MS instrument platform with the Agilent 7700e ICP-MS, designed to deliver high-performance, routine elemental analysis at an affordable price. The updated ICP-MS MassHunter Workstation provides an all-new interface for instrument control, method setup and sequencing on Agilent 7700 Series ICP-MS systems. The new software release also introduces innovative productivity and ease-of-use features such as a startup scheduler and batch-and-queue sequence control. Fewer screens and a flat user interface simplify menu navigation, and all essential information is at the operator's fingertips. The result is software that is easy to learn and simple to operate. A key feature of the new ICP-MS MassHunter software is the use of pre-set methods, which allow users to choose from pre-defined sets of operating and acquisition conditions for the analysis of well-characterized sample types. As well as defining the auto-tuning parameters and the plasma conditions to be used, the pre-set methods also pre-load the analyte list, select the internal standards, set the integration times and define the preferred cell mode and any correction equations required for each analyte. The result is that many routine applications can be run without any manual tuning or method development, using consistent and optimum conditions regardless of the operator's expertise. The 7700e is a new addition to the Agilent 7700 Series ICP-MS family, developed with the emphasis on streamlined and simplified operation for common applications. The new ICP-MS MassHunter comes in two versions, core and full. The core version of MassHunter, which ships as standard with the new 7700e model, includes the standard functionality required for typical routine analysis. The full version of the new MassHunter software ships as standard with the 7700x and 7700s models, and includes advanced functions such as makeup gas control, used for high-matrix introduction (HMI) operation on the 7700x; flexible manual tuning modes; fast cell gas switching; and advanced acquisition modes, including half-mass acquisition, time-resolved analysis, isotope ratio and isotope dilution. For details, visit http://www.agilent.com/chem/icpms.
Thermo Fisher Scientific Publishes New Poster Illustrating the Benefits of Integrating Comprehensive Solutions for Biobanks
Thermo Fisher Scientific Inc., the world leader in serving science, is offering a new technical poster demonstrating its comprehensive portfolio of offerings for biobanks and biorepositories. Thermo Fisher Scientific has the world's largest breadth of offerings for biobanks, from biospecimen collection, processing, testing and storage to sample and data management. The new poster, The Cure for Your Biobanking Informatics Challenges, was authored by senior technical managers from Thermo Fisher Scientific and highlights the growing need for modern biobanks to find efficient and cost-effective methods of storing and accessing samples. It is available for free download at www.thermoscientific.com/biobankposter The new poster outlines how the company's work with some of the world's most renowned biobanks, including UK Biobank and HUNT Biobank, has enabled it to feature a range of expertise in its biobanking module. It also demonstrates how Thermo Fisher Scientific solutions allow customers to get up-to-speed quickly with the flexibility to meet individual requirements and business needs. The company's end-to-end portfolio for biobanks includes centrifuges, concentrators, freezers, robotics, 2D barcodes, microplate readers, mass spectrometers and comprehensive services that enable turn-key biobanking solutions. In addition, the poster highlights the company's innovative services and software for biorepositories, including laboratory information management systems, laboratory equipment and storage and related services. The emergence of biobanking modules that facilitate integration with laboratory information management systems (LIMS) provide biobanks with the tools needed to manage sample login, tracking and shipping as well as securely store critical donor information. Thermo Scientific Nautilus LIMS biospecimen tracking software is specifically designed for data capture, location management, chain-of-custody and handling assurance requirements. Furthermore, this information can be integrated with laboratory instruments, assay/test request, and results capture and reporting. For details and to download the poster at no charge, visit http://www.thermoscientific.com/biobankposter.
Bruker Rings NASDAQ Opening Bell on Company's 50th Anniversary
Bruker Corporation announced that its management team will ring the Opening Bell at the NASDAQ Stock Market on Tuesday, September 7, 2010 at 9:30 a.m. EDT at the NASDAQ MarketSite in New York City's Times Square. Bruker Corporation is a leading provider of high-performance scientific instruments and solutions for molecular and materials research, as well as for industrial, clinical and applied analysis. Dr. Frank Laukien, Bruker's President and Chief Executive Officer, stated: "We are very honored to ring the NASDAQ opening bell to celebrate Bruker's 50th anniversary on September 7, 2010. For the past 50 years, we have built a solid and broad foundation for a fast-growing, pioneering scientific instruments company, based on delivering innovative, high-performance products and high-quality support to our customers. We take great pride in what our employees and company have achieved for enabling our customers with research and analytical tools, and we will continue to adapt to the changing opportunities as we plan for Bruker's long-term profitable growth and success." A webcast of this event will be available on the Investor section of the Company's website at http://ir.bruker.com.
Abbott Completes Acquisition of Piramal's Healthcare Solutions Business, Becomes Leading Pharmaceutical Company in India
Abbott has completed its acquisition of Piramal's Healthcare Solutions business, propelling it to market leadership in the Indian pharmaceutical market and further accelerating the company's growth in emerging markets. Throughout the past decade, Abbott has established a leading presence in emerging markets - today, more than 20 percent of the company's total sales are generated in these growing economies. "The acquisition of Piramal's Healthcare Solutions business further strengthens Abbott's growing presence in emerging markets," said Miles D. White, chairman and chief executive officer, Abbott. "Piramal's portfolio of well-known, trusted products has served patients in India for decades. Combined with existing product offerings, Abbott is uniquely positioned to meet the needs of one of the world's fastest-growing pharmaceutical markets." India's rapid pharmaceutical market growth is being driven largely by branded generics. The market will generate nearly $8 billion in pharmaceutical sales this year, a number that is expected to more than double by 2015. Abbott expects its pharmaceutical sales in India to exceed $2.5 billion by 2020. Piramal's Healthcare Solutions business has a comprehensive portfolio of branded generics, including market-leading brands in multiple therapeutic areas, including antibiotics, respiratory, cardiovascular, pain and neuroscience. The Healthcare Solutions business will operate as a separate business unit, reporting into Abbott's newly-created Established Products Division (EPD), which was formed to focus on branded generics, maximizing the opportunity in emerging markets. The business will continue to be led by its current India-based management team. "Piramal's proven business model in India and experienced local leadership team, combined with the global resources of Abbott, will allow us to build upon Piramal's commitment to quality and service," said Michael J. Warmuth, senior vice president, Established Products, Pharmaceutical Products Group, For details, visit http://www.abbott.com.
Agilent Technologies and South Bend Medical Foundation Developing LC/MS/MS Methods to Comply with New Federal Workplace Drug Testing Guidelines
Agilent Technologies Inc. and South Bend Medical Foundation have collaborated to develop urine testing methods to meet the new mandatory guidelines for federal workplace drug testing. The new guidelines, which are scheduled to take effect Oct. 1, will allow for the first time use of liquid chromatography/triple quadrupole mass spectrometry (LC/MS/MS) for confirmatory urine drug testing. The resulting methods will be validated per National Laboratory Certification Program guidelines by the staff at South Bend. The methods will use the same column so that all five required drug classes can be analyzed on a single LC/MS/MS instrument without system changes. The methods will be accompanied by well-documented standard operating procedures, including sample preparation, to accelerate implementation and facilitate training of laboratory personnel. “We frequently hear that the main barriers to adopting the new technologies required to drive laboratory productivity and/or cost reductions are lack of time and in-house expertise,” said Tom Gluodenis, Jr., Agilent worldwide forensics program manager. “We’re now making it easier for busy labs to reap the benefits of these new guidelines with minimal time and effort in method development. For example, the tools we have just developed in response to the changing workplace guidelines could enable laboratories to validate these methods and be running billable urine confirmations in under 60 days.” Use of LC/MS/MS for urine drug confirmations speeds testing and reduces cost-per-sample compared to previous methods. In addition, several new target drugs have been added to the panel, several cut-off concentrations have been adjusted, and the minimum requirements for interference testing have been satisfied for amphetamines and opiates. Also, the new requirement specifying at least 10 data points across a peak can be met. In addition to collaborating with Agilent to develop the new methods, the South Bend Medical Foundation will participate in the training of Agilent’s field representatives. This will enhance Agilent’s ability to support laboratories seeking to implement these testing methods. The South Bend Medical Foundation’s Toxicology Department, established in 1975, is one of the original 10 labs accredited by Substance Abuse and Mental Health Services Administration (SAMHSA, formerly NIDA), through the National Laboratory Certification Program - Department of Health and Human Services. For details, visit http://www.agilent.com.
FDA to Tackle Industry Concerns in First Biosimilars Meeting
The FDA may end its silence on how an approval pathway for biosimilars will work once it gets feedback at its first public meeting on the topic next month. The meeting, which will be held Nov. 2 and 3, will address several of industry's most pressing questions since the creation of the pathway earlier this year. Issues slated for discussion include what it will take for a product to be deemed "interchangeable" and how a biosimilars user fee program should be structured, the FDA says in a Federal Register notice. The 2-day public hearing is designed to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to, or “interchangeable” with, an FDA-licensed biological product. The purpose of this public hearing is to create a forum for interested stakeholders to provide input regarding the agency's implementation of the statute. FDA will take the information it obtains from the public hearing into account in its implementation of the BPCI Act. For details, visit http://www.federalregister.gov.
FDA Unveils New Office of Science and Innovation
Delivering on her promise to promote regulatory science to help drugmakers get their treatments to market faster, FDA Commissioner Margaret Hamburg announced the agency will establish an Office of Science and Innovation. The office, which will be housed within the Office of the Chief Scientist, will develop strategic plans, track outcomes, organize scientific collaborations and monitor outside partnerships with input from a new strategic advisory council and the Science Board, Hamburg said as she unveiled an FDA Regulatory Science Initiative report. For details, visit http://www.fda.gov.
FDA Wants Companies, Agency to Take Bigger Steps Abroad
The FDA is trying to stretch its enforcement reach over foreign drug suppliers, potentially through consent decrees, and is asking manufacturers to take bigger steps as well to tighten the pharmaceutical supply chain. Currently, the FDA only has authority to establish import alerts for foreign companies with good manufacturing practice violations, but it is looking at other options, Carmelo Rosa, compliance officer with CDER’s Division of Manufacturing & Product Quality, said. For details, visit http://www.fda.gov.
FDA Could Give New Guidance on Nanotechnology
Drugmakers will likely see new guidance and consensus standards on nanotechnologies in the near future as the FDA moves forward on its research and regulation of the technologies. The agency also could produce new test methods, publications and presentations as part of its 2011 Nanotechnology Regulatory Science Initiative, Subhas Malghan, deputy director for program policy and evaluation at the Center for Devices and Radiological Health, said at a recent meeting of the FDA’s Science Board. For details, visit http://www.fda.govDrug Labeling Changes Come Into Effect in October
Drugmakers have until Oct. 30 to comply with new labeling provisions for medicines in the UK. The changes, mandated by a 2005 law, require manufacturers to prominently display the common names of all active substances on the product packaging, following the brand name, if one is used. The name registered in the summary of product characteristics also must appear in Braille on the packaging. For details, visit http://www.fda.gov
FDA Draft Guidance Harmonizes Regional Powder Density Texts
The FDA plans to accept International Conference on Harmonisation (ICH) standards for bulk density and tapped density of powders as part of an ongoing harmonization project intended to reduce paperwork for drugmakers. Acceptance of the standards would allow drugmakers submitting dossiers in ICH regions to use the U.S., European and Japanese pharmacopoeial texts interchangeably with some conditions, according to a draft guidance. Comments on the draft are due Sept. 12. For details, visit http://www.fda.gov
FDA Commissioner Says Agency Needs More Authority
Food and Drug Administration chief Margaret Hamburg said her agency is limited by law to a mostly reactive stance on food safety and argued that it needs a more "preventive approach." Giving a series of network interviews in the wake of the egg and salmonella breakout, Hamburg said the FDA is taking the issue "very, very seriously." At the same time, she said Congress should pass pending legislation that would provide her agency with greater enforcement power, including new authority over imported food. "We need better abilities and authorities to put in place these preventive controls and hold companies accountable," Hamburg said as she discussed the approximately 1,300 cases of salmonella poisoning and the recall of roughly a half-billion eggs from two Iowa egg distributors. She also had some practical advice for consumers: Reject over-easy eggs. She said that as federal investigators continue their work with the companies involved, consumers should strictly avoid "runny egg yolks for mopping up with toast." Two Iowa farms linked to the disease outbreak — Wright County Egg and Hillandale Farms — share suppliers of chickens and feed as well as ties to an Iowa business with a history of violating state and federal law. The number of illnesses, which can be life-threatening, especially to those with weakened immune systems, is expected to increase. The most common symptoms are diarrhea, abdominal cramps and fever eight to 72 hours of eating a contaminated product. Jewanna Porter, a spokeswoman for the egg industry, said Saturday the company Quality Egg supplies young chickens and feed to both Wright County Egg and Hillandale Farms. The two share other suppliers, she said, but she did not name them. The egg industry has consolidated over recent years, placing fewer, larger businesses in control over much of the nation's egg supply to consumers. The salmonella outbreak has raised questions about federal inspections of egg farms. The FDA oversees inspections of shell eggs, while the Agriculture Department is in charge of inspecting other egg products. Businessman Austin "Jack" DeCoster owns Wright County Egg and Quality Egg. Wright County Egg recalled 380 million eggs Aug. 13 after it was linked to more than 1,000 cases of salmonella poisoning. A week later, Hillandale Farms recalled 170 million eggs. DeCoster's companies have a long history of problems:
- In 1994, the state of Iowa assessed at least four separate penalties against DeCoster Farms for environmental violations, many of them involving hog waste.
- In 1997, DeCoster Egg Farms agreed to pay $2 million in fines to settle citations brought in 1996 for health and safety violations at DeCoster's farm in Turner, Maine. The nation's labor secretary at the time, Robert Reich, said conditions were "as dangerous and oppressive as any sweatshop." Reich's successor, Alexis Herman, called the state of the farms "simply atrocious," citing unguarded machinery, electrical hazards, exposure to harmful bacteria and other unsanitary conditions.
- In 2000, Iowa designated DeCoster a "habitual violator" of environmental regulations for problems that included hog manure runoff into waterways. The label made him subject to increased penalties and prohibited him from building new farms.
- In 2002, the federal Equal Employment Opportunity Commission announced a more than $1.5 million settlement of an employment discrimination lawsuit against DeCoster Farms on behalf of Mexican women who reported they were subjected to sexual harassment, including rape, abuse and retaliation by some supervisory workers at DeCoster's Wright County plants.
- In 2007, 51 workers were arrested during an immigration raid at six DeCoster egg farms. His farms had been the subject of at least three previous raids.
- In June 2010, Maine Contract Farming, the successor company to DeCoster Egg Farms, agreed in state court to pay $25,000 in penalties and to make a one-time payment of $100,000 to the Maine Department of Agriculture over animal cruelty allegations that were spurred by a hidden-camera investigation by an animal welfare organization.
In a statement on Aug 22, 2010, Wright County Egg spokeswoman Hinda Mitchell said the company had reacted quickly in the past to correct its operations when "issues have been raised about our farms. We are approaching our work with FDA in the same forthright manner." The FDA investigation could take months, and sources of contamination are often difficult to find. For details, visit http://www.fda.gov.
Thursday, 18 November 2010
LIMSource News: What's New in September & October 2010
via limsource.com
