Applied Biosystems Introduces New Rapid Molecular-based System for Mycoplasma Contaminant Detection in Biopharmaceutical Manufacturing

Recent recalls in the pharmaceutical industry have increased awareness of the need to improve contaminant and impurity analysis in drug manufacturing. Biopharmaceutical companies are responding to this challenge for products produced in cell culture to include in-process contaminant and impurity analysis for rapid detection of the smallest known self-replicating organism, called Mycoplasma. To assist in these efforts to address the presence of contamination, Applied Biosystems Inc. (NYSE:ABI) is introducing a new molecular-based system to detect Mycoplasma rapidly and accurately during biopharmaceutical manufacturing.

The new MicroSEQ^® Mycoplasma Detection System is intended to help biopharmaceutical companies reduce risk, save costs and increase efficiency in their manufacturing processes. It is the first system to combine comprehensive and accurate detection with high-speed capabilities for in-process testing, accurately detecting up to 90 species of Mycoplasma in only a few hours. This system is designed to facilitate faster decision making by delivering critical information that can take as long as four weeks to obtain with traditional culture methods.

Contamination can occur at any stage of the manufacturing process from a variety of sources, including raw materials, equipment, laboratory personnel and contact with infected substances. For analysis of contaminants such as bacteria, Mycoplasma and fungi, rapid molecular methods are gaining increasing attention in pharmaceutical manufacturing. They are addressing the problems of inadequate sensitivity and delayed time-to-results that can lead to delays in manufacturing and the release of pharmaceutical products.

The MicroSEQ Mycoplasma Detection System is part of Applied Biosystems’ SEQ portfolio of fast, accurate methods for testing of potential contaminants and impurities that may be present in the pharmaceutical manufacturing process. Applied Biosystems is building on the success of its MicroSEQ^® Microbial Identification System, which is now routinely used in large-scale pharmaceutical manufacturing processes to identify bacterial and fungal contamination in product and environmental samples. Expanding the SEQ portfolio to include in-process contaminant and impurity analysis is expected to broaden the use of the company’s PCR, real-time PCR and DNA sequencing-based technologies in pharmaceutical manufacturing.

Among the experts supporting the shift to rapid molecular methods for pharmaceutical manufacturing is Dr. Robert Johnson, Ph.D., who chairs the European Compliance Academy working group on rapid microbiological methods and is currently CEO of Dialogue, a consultancy that assists pharmaceutical companies refining quality control strategies. Dr. Johnson spent many years working to ensure quality and safety at leading pharmaceutical companies, such as Wyeth, GlaxoSmithKline and others. In his leadership role, he is making a significant impact on creating guidelines for pharmaceutical companies to revamp their monitoring capabilities with rapid molecular methods, which are now being adopted as a means to improve quality and safety.

"Results from rapid molecular-based testing are providing better information for more timely and informed decision making and increasing the safety and quality of pharmaceutical products,” said Dr. Johnson. "The regulators and pharmacopoeias are catching on to the benefits of rapid molecular methods that are emerging as the new Gold standard for contaminant and impurity analysis performed in pharmaceutical manufacturing. Faster and more accurate detection of Mycoplasma can have a significant impact on preserving the high quality of the biopharmaceutical manufacturing process.”

Rapid molecular methods utilize PCR, real-time PCR and DNA sequencing technologies to detect and analyze the DNA of microorganisms. Scientists can use these methods to detect and identify microorganisms at extremely low levels. The new Mycoplasma detection system uses real-time PCR – a common laboratory method used to detect the amount of nucleic acids present in biological samples simultaneously – and integrates sample preparation with broad species detection and analysis. This enables biopharmaceutical companies to apply a more effective workflow for detecting Mycoplasma.

The use of real-time PCR results in significant time savings and enables faster responses to the presence of contamination. Same-day detection of Mycoplasma allows for in-process testing during manufacturing. Mycoplasma contamination can be detected at the earliest possible opportunity before compromising downstream processes. Quick action can be taken to better preserve pharmaceutical companies’ investments in bringing pharmaceutical products to market.

Applied Biosystems is a global leader in the development and commercialization of instrument-based systems, consumables, software and services for the life science market. The company is also a worldwide leader in PCR, real-time PCR and DNA sequencing, which are core technologies for a wide range of research and monitoring applications. These technologies are the foundation for Applied Biosystems’ rapid molecular methods for the pharmaceutical industry. The basis for the new Mycoplasma detection system is the Applied Biosystems 7500 Fast Real-time PCR System, a premier instrument system for detection and one of the leading systems in the company’s broad portfolio.

"Comprehensive monitoring of pharmaceutical and biopharmaceutical manufacturing facilities is critical for ensuring product safety and quality,” said Robert Barrett, vice president for Applied Biosystems’ applied markets division. "Applied Biosystems is providing a world-class, rapid molecular-based system for comprehensive and fast results to improve efforts to detect the occurrence of Mycoplasma in their processes, ultimately reducing overall product risk.”

For more information about Applied Biosystems’ rapid molecular methods for pharmaceutical manufacturing, visit www.appliedbiosystems.com/microseq. For more information about the real-time PCR and DNA sequencing, visit www.appliedbiosystems.com.

About Applied Biosystems Inc.

Applied Biosystems Inc. (formerly known as Applera Corporation) is a global leader in the development and marketing of instrument-based systems, consumables, software, and services for academic research, the life science industry and commercial markets. Driven by its employees' belief in the power of science to improve the human condition, the company commercializes innovative technology solutions for DNA, RNA, protein and small molecule analysis. Customers across the disciplines of academic and clinical research, pharmaceutical research and manufacturing, forensic DNA analysis, and agricultural biotechnology use the company’s tools and services to accelerate scientific discovery, improve processes related to drug discovery and development, detect potentially pathogenic microorganisms, and identify individuals based on DNA sources. Applied Biosystems has a comprehensive service and field applications support team for a global installed base of high-performance genetic and protein analysis solutions. Applied Biosystems Inc. is headquartered in Norwalk, CT. On June 12, 2008, Applera Corporation and Invitrogen Corporation (NASDAQ: IVGN) announced that their Boards of Directors had approved a definitive merger agreement under which Invitrogen will acquire all of the outstanding shares of Applied Biosystems stock. The merger is subject to customary closing conditions and is targeted to close in the fall of 2008. Further information regarding the merger has been provided in a joint proxy statement/prospectus mailed to stockholders of the company and Invitrogen. Investors and security holders are urged to read this document because it contains important information. Information about Applied Biosystems, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.appliedbiosystems.com. All information in this news release is as of the date of the release, and Applied Biosystems does not undertake any duty to update this information unless required by law.

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