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Free White Paper Discusses Complexity of Virus Testing for Biological Products, How Best to Partner with Contract Labs
AGAWAM, MASSACHUSETTS – November 17, 2008 – As the number of biological drugs continues to increase, so does the complexity involved in the virus contamination testing of those products. A free white paper discussing the challenges of virus contamination testing – along with tips on how best to partner with a contract lab on such testing – is available for free download at: www.microtestlabs.com/biopaper. “In the manufacture of biological products derived from living organisms, such as bacterial, yeast, or mammalian cells, animals, and humans, the potential for virus contamination can occur at many levels from raw materials through processing. Virus testing is required when there is any risk of contamination to ensure the safety of biologics prior to use in humans,” said Merribeth Morin, Ph.D, Director of Virology at Microtest, and author of the white paper, “ Virus Testing for Biological Products: Partnering With a Contract Lab.” In the white paper, Dr. Morin discusses the sources and opportunities of contamination of a biological product. She notes various virus testing considerations for mammalian cell culture based systems, such as the use of animal derived raw materials, cell bank characterization, virus concerns during the manufacturing process – and discusses the implications of other biologic products. The white paper also offers tips on planning and initiating the testing process along with advice on how to select and work with a contract testing company to obtain the best possible benefits. With a Ph.D. in Virology from Harvard University and having served as Director of Virology at the former Q-One Biotech, Dr. Morin has extensive experience in virology/biosafety testing services. Dr. Morin oversees Microtest’s complete range of pharmaceutical and virology test services which support full in-process and product release testing as well as product stability testing, raw material qualification and assay development/validation. The services help companies reduce costs and risk, support rapid regulatory approvals, and benefit from reliable, fast, turn-arounds. Download the free white paper, “ Virus Testing for Biological Products: Partnering With a Contract Lab,” at: www.microtestlabs.com/biopaper. Or, for more information, contact Microtest at http://www.microtestlabs.com/ or toll-free at: 1-800-631-1680. About MicrotestMicrotest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.
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Labels: biological products, contamination, contract lab, contract laboratory, lab testing, virology, virus contamination testing
White Paper Details How DNA Sequencing Services Can Prevent Cleanroom Shutdowns at Medical Device and Pharmaceutical Manufacturers
 AGAWAM, MASS. – November 11, 2008– Contamination by an unknown organism often calls for total shutdown of a cleanroom’s operation until that organism can be identified and eliminated. Such shutdowns can have catastrophic effects on the schedules and productivity of medical device and pharmaceutical manufacturers alike. A new white paper, “ The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” outlines common sources of contamination, discusses problems and delays associated with traditional methods of identifying those contaminants and highlights breakthrough solutions to these difficulties. The white paper is available, free, for download at: http://www.microtestlabs.com/microseq/“Modern cleanrooms used for the manufacture of medical devices, pharmaceuticals, or combination products face widespread, persistent threats of contamination. Much of this contamination comes from the people working in these environments. They carry in invasive organisms on themselves –as well as on the equipment and materials they bring into the environment,” says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories. With more than 13 years' experience in regulatory microbiology and contract laboratory operations, Champagne leads Microtest's microbiology, contract analytical chemistry, laboratory support, and virology departments. He holds a B.S. degree in microbiology from Iowa State University, and is a nationally-registered microbiologist. “Fast action is vital. To get the cleanroom back up and running as quickly as possible, the extent and location of areas affected must be determined, and the exact organism responsible identified,” Champagne said. The white paper identifies the shortcomings of traditional identification methods, such as only identifying bacteria or yeast only; requiring live, isolated colonies; demanding colonies grown in specific media to match library; delivering subjective results; requiring matches against appropriate library for accurate ID; providing library IDs based on multiple strains/species for each entry; and long turnaround times. As opposed to traditional methods, DNA sequencing for microbial identification has proven highly accurate and is ideal for testing applications, Champagne explains in the white paper. These include pharmaceutical quality assurance/ quality control labs, finished product and in-process testing, media fill failure investigations, sterile medical products, opthalmics, medical devices, cosmetics, and nutritional supplements. Once the organism is positively identified, managers can much more easily deduce the source or sources of contamination, and take swift corrective action to enable the resumption of manufacturing production. Download the new white paper, “ The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns,” at http://www.microtestlabs.com/microseq/About MicrotestMicrotest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.
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 Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/services/public-relations/index.html
 bookmark to del.icio.us Technorati tags: Microtest, medical device, analytical laboratory, sterility validation, release testing, analytical services, clean room testing, cleanroom testing, DNA sequencing, microbial identification, pharmaceutical quality assurance, quality control labs, in-process testing, media fill failure investigations, sterile medical productsLabels: clean room, cleanroom, in-process testing, media fill failure investigations, microbial identification, pharmaceutical quality assurance, quality control labs, sterile medical products, testing
Free Seminar for Medical Device Makers on Importance of Sterile Package Validation Set for Nov. 12th
A free morning-long seminar to help New England-based medical device manufacturers negotiate the increasing important – and complex – challenges of sterile package validation is scheduled for November 12th in Agawam, Mass. “FDA concerns regarding terminally sterilized medical products are based on years of data that implicates failures in primary packaging. The majority of failures occur because of inadequate package validation programs,” says Steven Richter, Ph. D., president and CEO of Microtest, a leader in medical device testing services, including medical device package stability and validation testing. The seminar will detail the necessary sterilization processes and test methods that should be part of any reliable validation program to avoid such failures, Richter said. Titled " Package Validation Requirements for Medical Devices and Combinatory Products," the seminar will detail the general concepts and problems associated with medical device packaging testing as well as reviewing different testing methodologies. Specific topics will include: The seminar will be held Nov. 12, 2008, from 10 a.m. through Lunch at Microtest Laboratories, Inc., 104 Gold St., Agawam, Mass. The seminar is free and lunch will be provided.
The seminar is free, but prior registration is required. To register, visit www.microtestlabs.com/packagingseminar or call toll-free 1-800-631-1680.
For directions to Microtest, visit http://www.microtestlabs.com/contact-us/index.html.
About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.
# # # Labels: free seminar, ISO 11607, ISTA shipping testing, medical device, medical device manufacturers, Microtest, New England, physical package test
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