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CBER's Perspective on Evaluation and Implementation of Rapid Microbial Methods

CBER Perspective Rapid Microbial Methods

Webinar Overview:

Listen to CAPT Simleen Kaur, Team Leader for Laboratory of Microbiology In-vivo Testing and Standards at FDA Center for Biologics and Evaluation and Research, and Lori Daane, Sr Director of Scientific Affairs at bioMérieux, discuss CBER’s current thinking concerning validation and implementation of rapid microbial methods and their evaluation to demonstrate the suitability of rapid microbial methods used in testing and release of biological products. 

Conventional microbiological methods are established and have been used for detection and identification of microbiological contamination in biological products for decades, but these methods are time consuming and can take several days or weeks to generate results. Rapid microbial methods use proprietary methods that utilize novel technologies and can provide efficient microbiological control and assurance to allow expedited release of products. Rapid methods can be implemented for in-process testing of pharmaceutical products, environmental monitoring, and final release testing of biological products.

CAPT Simleen Kaur has a Masters in Biotechnology from Johns Hopkins University and a Bachelors in Biology from the University of Delhi in India. She is currently stationed in Food and Drug Administration, under Center for Biologics and Evaluation and Research, Office of Compliance and Biologics Quality. Lori Daane has over 30 years of experience in clinical, environmental, and industrial microbiology. She is a technical expert on rapid and alternative methods and provides scientific support to the Healthcare business in North America. Prior to joining bioMérieux, Lori worked for 11 years at Celsis in a variety of technical roles, including VP of Scientific Affairs and Reagent Development.

If you’d like to know more about some of our rapid microbial methods, the BACT/ALERT® 3D is a microbial detection system suitable for any size laboratory, providing you with a reliable and objective alternative to traditional microbial detection methods.