Applied Biosystems (ABI) Release: MicroSeq Microbial Identification System Assists Drug Manufacturers In Compliance With FDA Current Good Manufacturing Practices
10/19/2005 5:13:12 PM
FOSTER CITY, Calif. & CHICAGO--(BUSINESS WIRE)--April 5, 2005--
First DNA-based System to Provide Advanced Identification Methods of Sterility Isolates to the Species Level
Applied Biosystems (NYSE:ABI), an Applera Corporation business, today 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.
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