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 CARLSBAD, Calif. -- Applied Biosystems, a division of Life Technologies Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :LIFE), today announced the launch of the life science industry's first integrated real-time PCR PCR polymerase chain reaction. PCR abbr. polymerase chain reaction Polymerase chain reaction (PCR) solution for measuring residual DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. impurities from Chinese Hamster Ovary ovary, ductless gland of the female in which the ova (female reproductive cells) are produced. In vertebrate animals the ovary also secretes the sex hormones estrogen and progesterone, which control the development of the sexual organs and the secondary sexual (CHO CHO Carbohydrate (chemical formla Carbon Hydrogen Oxygen) CHO Chinese Hamster Ovary CHO Chemical Hygiene Officer CHO Chief Health Officer (corporate title) ) host cells. The new solution significantly enhances the ability of biopharmaceutical companies to rapidly and accurately quantitate quan·ti·tate tr.v. quan·ti·tat·ed, quan·ti·tat·ing, quan·ti·tates To determine or measure the quantity of. [Back-formation from quantitative (analysis). 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 Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , inflammatory diseases, multiple sclerosis and viral infection viral infection, n an infection by a pathogenic virus. A virus acts on the cell nucleus, taking over the genetic material within the nucleus and replicating itself. . 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 nucleic acid, any of a group of organic substances found in the chromosomes of living cells and viruses that play a central role in the storage and replication of hereditary information and in the expression of this information through protein synthesis. 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[TM] CHO Residual DNA Quantitation and PrepSEQ[TM] Sample Preparation kits are the latest additions to the SEQ SEQ Sequence SEQ Sequential SEQ South East Queensland (Australia) SEQ Smart Equities Conference SEQ Sequens/Sequentes SEQ Senior Enlisted Quarters SEQ Short Essay Question SEQ Stigmatisation and Eczema Questionnaire SEQ Scientific Equipment 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([R] )Microbial microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. Identification System and MicroSEQ([R]) Mycoplasma mycoplasma Any of the bacteria that make up the genus Mycoplasma. They are among the smallest of bacterial organisms. The cell varies from a spherical or pear shape to that of a slender branched filament. 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 DNA testing Analysis of DNA (the genetic component of cells) in order to determine changes in genes that may indicate a specific disorder. Mentioned in: Acoustic Neuroma, Retinoblastoma, Von Willebrand Disease , 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 picogram /pi·co·gram/ (pg) (pi´ko-gram) one-trillionth (10-12) of a gram. pi·co·gram n. Abbr. pg One-trillionth (10-12) of a gram. 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." Additional Resources Technical Details Product Brochure 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 DNA analysis Any technique used to analyze genes and DNA. See Chromosome walking, DNA fingerprinting, Footprinting, In situ hybridization, Jeffries' probe, Jumping libraries, PCR, RFLP analysis, Southern blot hybridization. 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. Life Technologies' Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement This press release includes forward-looking statements about our anticipated results that involve risks and uncertainties. Some of the information contained in this press release, including, but not limited to, statements as to industry trends and Life Technologies' plans, objectives, expectations and strategy for its business, contains forward-looking statements that are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Any statements that are not statements of historical fact are forward-looking statements. When used, the words "believe," "plan," "intend," "anticipate," "target," "estimate," "expect" and the like, and/or future tense or conditional constructions ("will," "may," "could," "should," etc.), or similar expressions, identify certain of these forward-looking statements. Important factors which could cause actual results to differ materially from those in the forward-looking statements are detailed in filings made by Life Technologies with the Securities and Exchange Commission. Life Technologies undertakes no obligation to update or revise any such forward-looking statements to reflect subsequent events or circumstances. Copyright 2009. Life Technologies Corporation. All rights reserved. PrepSEQ and resDNASEQ are trademarks and MicroSEQ is a registered trademark of Life Technologies Corporation. |
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