MicroSeq Microbial Identification System Assists Drug Manufacturers in Compliance With FDA Current Good Manufacturing Practices
Applied Biosystems, an Applera Corporation business, announced that its MicroSeq(R) Microbial Identification System supports customers in meeting U.S. Food and Drug Administration (FDA) requirements for aseptic processing for the manufacture of sterile drug and biological products under current Good Manufacturing Practice (cGMP) regulations (21 CFR parts 210 and 211). The MicroSeq System is the first DNA 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 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 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 (DNA and RNA), 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) 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/ .
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 process is covered by patents owned by Roche Molecular Systems, Inc. and F. Hoffman-La Roche Ltd.
