New Real-time PCR Solution Introduced to Quantitate Host Cell DNA Impurities...

Applied Biosystems Introduces New Real-time PCR Solution to Quantitate Host Cell DNA Impurities in Biopharmaceutical Manufacturing
 
Integrated Sample Preparation and Rapid Molecular Kits Improve Quantitation of Critical Impurities

Applied Biosystems, a division of Life Technologies Corporation (NASDAQ:LIFE), today announced the launch of the life science industry’s first integrated real-time PCR solution for measuring residual DNA impurities from Chinese Hamster Ovary (CHO) host cells. The new solution significantly enhances the ability of biopharmaceutical companies to rapidly and accurately quantitate the impurities. The CHO cell lines are the primary medium used by biopharmaceutical companies to develop biological drugs, which are designed to treat a variety of medical conditions, including cancer, cardiovascular disease, inflammatory diseases, multiple sclerosis and viral infection.

A major challenge for biopharmaceutical companies is the accurate and sensitive quantitation and removal of host cell DNA impurities. Companies measure the amount of nucleic acid in both the manufacturing process and in final drug release. The new real-time PCR solution quantitates these nucleic acid impurities in four hours, which is an improvement over methods that deliver slower results with less specificity and sensitivity.

The resDNASEQ™ CHO Residual DNA Quantitation and PrepSEQ™ Sample Preparation kits are the latest additions to the SEQ portfolio of rapid molecular methods for pharmaceutical manufacturing. The new solution combines DNA isolation technology in a magnetic bead-based kit for high DNA recovery with a sensitive qPCR assay, including a genomic CHO standard for generating highly accurate and specific quantitation data.

Expanding the SEQ portfolio to include residual DNA quantitation is expected to broaden the use of Applied Biosystems real-time PCR technologies in pharmaceutical manufacturing. The new products complement other molecular detection solutions that include the MicroSEQ® Microbial Identification System and MicroSEQ® Mycoplasma Detection System, which are now routinely used by analytical groups supporting large-scale pharmaceutical manufacturing.

Philipp Goerttler, Ph.D., Quality & Compliance Scientist at Boehringer Ingelheim

"Efficient removal of host cell-derived DNA is a regulatory requirement in the production process of biopharmaceuticals. For residual DNA testing, we are focusing on lower quantification limits, shorter time to results and the implementation of a species-specific method for quantification. Based on our current evaluation results, the Applied Biosystems kit allows accurate quantification of CHO DNA in the picogram range and will be further evaluated for its suitability in routine testing."

Leonard Klevan, Ph.D., Division President of Applied Biosystems’ Applied Markets business

"Biopharma and biotech companies are seeking ways to improve their manufacturing processes. To address their needs, Applied Biosystems is extending its experience in rapid molecular technologies to improve testing for residual DNA. This is an integral component of our complete portfolio of solutions for every stage of bioproduction."

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Applied Biosystems Extends Beyond the Research Laboratory

Applied Biosystems is a global leader in applying biology to markets beyond research. These include food & environmental testing, forensic DNA analysis and bioproduction, contributing to people’s well-being and safety. Applied Biosystems, along with Invitrogen – a leading provider of platform independent, essential life science technologies for disease and drug research, bioproduction and diagnostics – is part of Life Technologies. Applied Biosystems and Invitrogen products are used in nearly every major laboratory in the world.

For more information, please visit: www.appliedbiosystems.com  and www.invitrogen.com .

About Life Technologies

Life Technologies Corporation (NASDAQ:LIFE) is a global biotechnology tools company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific exploration, driving to discoveries and developments that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance personalized medicine, regenerative science, molecular diagnostics, agricultural and environmental research, and 21st century forensics. Life Technologies had sales of more than $3 billion in 2008, employs approximately 9,500 people, has a presence in more than 100 countries, and possesses a rapidly growing intellectual property estate of approximately 3,600 patents and exclusive licenses. Life Technologies was created by the combination of Invitrogen Corporation and Applied Biosystems Inc. For more information on how we are making a difference please visit our website: www.lifetechnologies.com .