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

Conventional microbiological methods have been established and have been used for the detection and identification of microbiological contamination in biological products for decades. 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. This presentation will provide CBER’s current thinking concerning the validation and implementation of rapid microbial methods. and their evaluation to demonstrate the suitability of rapid microbial methods used in the testing and release of biological products.

Presented by CAPT Simleen Kaur, Team Leader for Laboratory of Microbiology In-vivo Testing and Standards at FDA Center for Biologics, Evaluation and Research

CAPT Simleen Kaur has a Masters in Biotechnology from Johns Hopkins University and a Bachelors in Biology from the University of Delhi (India). She is currently stationed in the Food and Drug Administration, under the Center for Biologics and Evaluation and Research, Office of Compliance and Biologics Quality. She serves as a team leader for the Laboratory of Microbiology In-vivo testing and Standards, where she reviews microbiological test methods used in the release of biological products as submitted in Biological License Applications and Supplements to ensure they are validated in accordance with the Code of Federal Regulations and different pharmacopoeia requirements. In addition, she manages the production and distribution of CBER reference materials used in potency testing of biological products such as vaccines before release to the public.

Lori Daane, Sr. Director of Scientific Affairs at BioMérieux

Lori Daane is the Senior Director of Scientific Affairs at BioMérieux and 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. Before joining BioMérieux, Lori worked for 11 years at Celsis in a variety of technical roles, including VP of Scientific Affairs and Reagent Development, where she helped develop and launch several new and improved products.  Lori received her Ph.D. from the University of Minnesota in Microbial Ecology, studying the influence of earthworm activity on microbial gene transfer in the environment. She performed postdoctoral research at Rutgers University focusing on the phytoremediation of polyaromatic hydrocarbons and at the Los Alamos National Laboratory studying microbial communities associated with cryptobiotic soil crusts. She also holds a Master’s degree in Limnology and a Bachelor’s degree in Medical Technology.

Jon Kallay, Senior Technical & Market Development Manager, Charles River Microbial Solutions

Jonathan (Jon) Kallay is a senior technical and market development manager working remotely for the Microbial Solutions product lines.  He is a subject matter expert on microbiological investigations for manufacturing facilities that make regulated products. Jon provides practical laboratory experience to help clients identify the optimal path forward for their labs. Jon received his Bachelors in biochemistry from Denison University before earning a post-graduate diploma in pharmaceutical microbiology from the University of Manchester.

Sponsored by BioMérieux and Charles River Laboratories

About bioMérieux

With more than 50 years of pioneering diagnostics, the people of bioMérieux understand the challenges you face when it comes to ensuring product quality and are proud to offer the most comprehensive portfolio of solutions for microbiology quality control of biopharmaceuticals and ATMPs.  Choosing the right microbiology diagnostic can boost efficiency with in-process testing, and automation simplifies the testing processes, reduces human error, and helps ensure data integrity. Rapid, simple, at-line testing of key parameters allows in-process tests to be performed closer to the production environment and provides certainty that your manufacturing process is secure.

About Charles River Laboratories

For 30 years, Charles River has been dedicated to the development of precise, robust micro QC solutions that help bring your products to market safely and efficiently. Our mission is to provide industry-leading scientific and technological advances that not only meet ever-changing regulatory guidelines but also set a new standard in the way you perform testing. We’ve purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant, and measurable data to fuel confident decisions on product quality for release. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture, and protects your reputation.