|
|
 |
 |
 |
|
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.
# # #
Labels: biological products, contamination, contract lab, contract laboratory, lab testing, virology, virus contamination testing
“Biosafety Testing of Cell Lines Used in Vaccine and Virus Vector Production” is Focus of Presentation at WilBio Viral Vectors and Vaccines Conference
Merribeth Morin, PhD, of Microtest Laboratories will present “ Biosafety Testing of Cell Lines used in Vaccine and Virus Vector Production” at the WilBio Viral Vectors and Vaccines conference for Pandemic Viruses, Cancer Vaccines, and Gene Therapy, at 11:15 am-Noon, on Tuesday, Nov. 4, 2008 in Santa Barbara, Calif. Dr. Morin’s presentation will discuss the safety concerns for the use of cell lines, in reference to their use in vaccine and vector production. “The use of cell lines for the production of virus vectors and vaccines is widely applied. The ability to manipulate cells in culture and grow them to large scale is advantageous, and in the case of vaccines, presents a more attractive and consistent process than some more traditional methods for vaccine products. As for any type of biological product, using cell lines presents various safety considerations. There are a number of regulatory guidance documents that address the characterization of cells used for the production of biological products. The safety program for cell lines needs to be reasonable, but thorough, to address the safety concerns outlined in these documents,” said Dr. Morin. Dr. Morin is Director of Virology for Microtest Laboratories, ( http://www.microtestlabs.com/), a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. She received her PhD in Virology from Harvard University and has spent a number of years in both in vaccine research and in contract testing. Her research included developing DNA vaccines for the treatment of influenza virus infection and other infectious diseases, and the development of an attenuated vaccine for Herpes simplex virus infection. Based in Agawam, Mass., Microtest'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. The Viral Vectors and Vaccines Conference for Pandemic Viruses, Cancer Vaccines, and Gene Therapy runs Nov. 3-5, 2008. For more information, visit http://www.wilbio.com/.
# # #
Labels: biosafety testing, medical device, Microtest, pharmaceutical manufacturing, pharmaceutical testing, vaccine and virus vector, Viral Vectors and Vaccines, virology
Microtest Labs Doubles Microbial Identification, Analytical Services
The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified. “With the purchase of our second MicroSeq system, we are not only complimenting our existing unit but doubling our analytical capacity and ability to service our clients,” stated Dr. Steven Richter, Microtest President and Chief Scientific Officer. “As one of the only testing labs in the area with this technology, we are providing our customers with a significant competitive advantage.” Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. Traditional bacteria and mold identification lab tests are often less accurate, and require up to a one-week turn around time. “In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” stated Dr. Richter. “Our ability to provide rapid identification helps our customers minimize down-time, which directly affects their bottom-line. When manufacturing is halted or a cleanroom is shut-down and awaiting test results, there is no product going out the door and that translates to an interruption in sales.” The MicroSeq system is integrated for use across the spectrum of services that Microtest provides. Customers that will benefit most are those that utilize their analytical testing services in: · Contract Manufacturing
· Pharmaceutical Testing & Validation
· Medical Device Testing & Validation
· Environmental Control and Testing
· Water Validation
· Mold Identification
· Biologics/Virology The MicroSeq systems are 99% reliable with repeatable results, and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications. Made by the Applera Corporation, the MicroSeq Microbial Identification System is the most accurate and rapid bacterial identification system available today. 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 http://www.microtestlabs.com/ or call 1-413-786-1680 or toll-free 1-800-631-1680. Labels: Aseptic, Contract Manufacturer, drug, Fill/Finish, laboratory, manufacturing, Microseq, Microtest, pharmaceutical, Sterility Testing, virology
|
|
| |
|
|
|
|
Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/
bookmark to del.icio.us
Technorati tags: Microtest, virus contamination testing, contract laboratory, contract lab, biological products, lab testing, virology
