New Validated NAT Methods Provide Rapid Mollicute Screening and Bacterial Identification Testing Results

Billerica, Massachusetts—October 9, 2006—Millipore Corporation announced today that two validated methods for Nucleic Acid Techniques (NAT) for biopharmaceutical product testing are now available from MicroSafe Services from Millipore based in The Netherlands. The screening assay uses qualitative real-time polymerase chain reaction (QPCR) for the rapid screening of mollicutes and the bacterial identification assay is performed using sequencing analysis. The ability to detect the presence of contamination earlier in the drug manufacturing process as well as identify the specific bacterial species, enables key decisions to be made at various points in the drug manufacturing process, mitigating risk and improving quality assurance.

Mollicute Screening

The validated, rapid screening of mollicutes, of which mycoplasma is a member, enables manufacturers to test at any point and make any necessary adjustments to their manufacturing process. Dependent on the product to be tested, this assay can be adapted and validated to customers’ specific processes.

The rapid detection of mollicutes is performed using universal primers and SYBR Green I as the fluorescent dye in the QPCR. The specificity of the primers is directed but not limited to Acholeplasma laidlawii, Mycoplasma arginini, M. fermentans, M. gallisepticum, M. hyorhinis, M. orale, and M. synoviae, with a limit of detection of 1 CFU/mL.

Bacterial Identification

Also now available from MicroSafe Services from Millipore is a validated NAT method for accurate bacterial identification based on recent advances in rapid, molecular-based sequencing technologies. This method is applicable to all areas of biopharmaceutical processing when identification is necessary to assist with faster product release and implementation of corrective actions.

“The basis of microbial taxonomy has changed from its previous phenotypic base to a genotypic base. Genotypic typing is based on the sequencing of the highly conserved 16SRNA gene. The major consequence of this change is the perception that phenotypic identification methods have lost accuracy and precision. This perception causes significant problems for decisions concerning product disposition and complicates root cause analysis. The usage of NAT for genotypic typing is a powerful tool for determining root cause analysis. Additionally, its speed compared to classical identification techniques also fits at least philosophically with the FDA’s PAT initiative and assists with timely CAPA actions,” stated Mike Edgington, CEO of Edgington Associates BV.

These new tests methods from MicroSafe Services from Millipore support the PAT (Process Analytical Technology) initiative, which calls for manufacturers to audit their production line at multiple points. Obtaining results at various points helps pinpoint when contamination occurred as well as identify the bacteria present, allowing a manufacturer to take the necessary steps to correct their process.

Your partner in Microbiology

MicroSafe Services from Millipore delivers a complete range of critical testing and consultancy services throughout Europe for the development and production of biopharmaceuticals. Leaders in the field of microbiology including in vitro virology testing, our staff of accomplished scientists, engineers and microbiologists will help you meet your specific critical testing requirements through every phase of drug production. All testing is conducted under GMP and/or GLP certifications as well as our own internal quality system. For more information, visit www.millipore.com.

Millipore’s Bioprocess division delivers integrated solutions and services for every application, every step and every scale of the drug development and manufacturing process. With more than 50 years of experience, Millipore provides the world’s leading biotechnology and pharmaceutical companies with resources designed to improve yields, process economics and speed to market. For more information, visit www.millipore.com.

About Millipore

Millipore is a leading provider of products and services that improve productivity in biopharmaceutical manufacturing and in clinical, analytical and research laboratories. The Company is organized in two operating divisions. Its Bioprocess Division helps enables pharmaceutical and biotechnology companies to optimize their manufacturing productivity, ensure the quality of drugs, and scale up the production of difficult-to-manufacture biologics. Its Bioscience division helps to optimize laboratory productivity and workflows. Its products and enabling technologies that are used in the laboratory are essential for the research and development of biologically based life science therapeutics. Millipore has a deep understanding of its customers' research and manufacturing process needs, and offers reliable and innovative tools, technologies and services. The Company is part of the S&P 500 index and employs approximately 5,800 employees in more than 47 offices worldwide. For additional information on Millipore Corporation, please visit its website at: www.millipore.com.

MILLIPORE NEWS
For immediate release
Media Contact:
Shannon Meirzon
Marketing Communications Specialist
Millipore Corporation
978-762-5294

Shannon_meirzon@millipore.com

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