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MicroSeq Microbial Identification System Assists Drug Manufacturers in Compliance With FDA Current Good Manufacturing Practices.


FOSTER CITY, Calif. & CHICAGO -- First DNA-based System to Provide Advanced Identification Methods of Sterility Isolates to the Species Level

Applied Biosystems (NYSE NYSE

See: New York Stock Exchange
:ABI Abi (ā`bī) [short for Abijah], in the Bible, King Hezekiah's mother.


(Application Binary Interface) A specification for a specific hardware platform combined with the operating system.
), an Applera Corporation business, today announced that its 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 supports customers in meeting U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) requirements for aseptic processing for the manufacture of sterile drug and biological products under current Good Manufacturing Practice Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.  (cGMP) regulations (21 CFR CFR

See: Cost and Freight
 parts 210 and 211). The MicroSeq System is the first 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.
 sequence-based system to provide advanced identification of sterility isolates to the species level.

The announcement was made today in conjunction with the 2005 PDA (Personal Digital Assistant) A handheld computer for managing contacts, appointments and tasks. It typically includes a name and address database, calendar, to-do list and note taker, which are the functions in a personal information manager (see PIM).  Annual Meeting, the largest science and technology regulatory development meeting, April 4-8, 2005, in Chicago, IL, U.S.A.

"Sterility quality control is a critical part of manufacturing in the pharmaceutical, diagnostics, ophthalmics, food, and cosmetic industries," said Catherine M. Burzik, President of Applied Biosystems. "As pathogens are detected more frequently in the environment, it has become critical to develop faster and more accurate methods to help manufacturers identify microbial hazards. The MicroSeq(R) Microbial Identification System provides manufacturers a quality control tool to help them rapidly identify unknown organisms and mitigate the risks associated with production downtime and lot quarantine."

Unlike growth-based methods, the MicroSeq system can help manufacturers positively identify and classify even new and previously uncharacterized bacteria and fungi because the system uses PCR-based sequencing methods to amplify and rapidly identify organisms. The sequences are compared to a validated library for positive identification and taxonomic classifications.

The MicroSeq system provides microbial identification capacities for quality control to some of the world's largest clinical laboratories, environmental monitoring agencies, and pharmaceutical and vaccine manufacturers. The system allows users to develop properly documented manufacturing quality controls that can help them rapidly identify and solve sterility failures.

"Properly documented sterility control is critical for all of our customers, especially those in pharmaceutical manufacturing. Lapses can cause expensive downtime and the quarantine of entire lots," said Mark Stevenson, Division President, Applied Markets, Applied Biosystems. "Not only do our customers need products that speed up the manufacturing process, but they also need tools that will assist them to meet strict best practice guidelines practice guidelines Medical practice A set of recommendations for Pt management that identifies a specific or range of range of management strategies. See Peer review organization, Practice standards. Cf 'Cookbook' medicine.  for quality control and accuracy. The MicroSeq Microbial Identification System is a proven solution that gives our customers the confidence they need to address and solve these challenges."

The MicroSeq Microbial Identification System runs on Applied Biosystems DNA sequencing analysis systems and includes all the reagents necessary for sample preparation (DNA isolation) as well as Applied Biosystems' software and instrumentation tools that support manufacturers in meeting these guidelines.

For more information please visit http://www.microseq.com.

About Applera Corporation and Applied Biosystems

Applera Corporation consists of two operating groups. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids Nucleic acids
The cellular molecules DNA and RNA that act as coded instructions for the production of proteins and are copied for transmission of inherited traits.
 (DNA and RNA RNA: see nucleic acid.
RNA
 in full ribonucleic acid

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic
), small molecules, and proteins to make scientific discoveries, develop new pharmaceuticals, and conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of $1.7 billion during fiscal 2004. The Celera Genomics Group (NYSE:CRA See Community Reinvestment Act. ) is engaged principally in the discovery and development of targeted therapeutics for cancer, autoimmune and inflammatory diseases. Celera Genomics is leveraging its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets, and to discover and develop small molecule therapeutics. It is also seeking to advance therapeutic antibody and selected small molecule drug programs in collaboration with global technology and market leaders. Celera Diagnostics, a 50/50 joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of diagnostic products. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com, or by telephoning 800-762-6923. Information about Applied Biosystems is available at http://www.appliedbiosystems.com/.

Forward-Looking Statements

Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "expect," "intend," "anticipate," "should," and "planned," among others. These forward-looking statements are based on Applera Corporation's current expectations. The Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995 provides a "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.
" for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera Corporation notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to (1) rapidly changing technology and dependence on development of new products; (2) sales dependent on customers' capital spending capital spending

Spending for long-term assets such as factories, equipment, machinery, and buildings that permits the production of more goods and services in future years.
 policies and government-sponsored research; and (3) other factors that might be described from time to time in Applera Corporation's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

For research use only. Not for use in diagnostic procedures.

Copyright(C) 2005. Applera Corporation. All rights reserved. Applied Biosystems, Celera, and MicroSeq are registered trademarks and Applera, and Celera Genomics are trademarks of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries.

The PCR PCR polymerase chain reaction.

PCR
abbr.
polymerase chain reaction


Polymerase chain reaction (PCR) 
 process is covered by patents owned by Roche Molecular Systems, Inc. and F. Hoffman-La Roche Ltd.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 5, 2005
Words:903
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