MicroSeq Microbial Identification System assists drug manufacturers in compliance with FDA current good manufacturing practices

FOSTER CITY, Calif. & CHICAGO–(BUSINESS WIRE)–April 5, 2005–Applied Biosystems, an Applera Corporation business, today announced that its MicroSeq 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 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.


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