First DNA-based System to Provide Advanced Identification Methods of Sterility Isolates to the Species Level
Applied Biosystems, an Applera Corporation business, have announced that its MicroSeq® Microbial Identification System supports customers in meeting U.S. 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 in conjunction with the 2005 PDA Annual Meeting. 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 worlds 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.
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.
Source: Applied Biosystems View latest company information
Posted: April 11, 2005
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