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.
“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.
For more information, contact Microtest at http://www.microtestlabs.com/ or toll-free at: 1-800-631-1680.
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 http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680.
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