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

CAPT Simleen Kaur, at FDA, Lori Daane at bioMérieux and Jon Kallay at Charles River Microbial Solutions

Conventional microbiological methods are established and have been used for detection and identification of microbiological contamination in biologica...

7 months ago 119 mins

Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century

Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro Biosystems

Today Pharmaceutical industry remains conservative for microbiology testing methods and has reluctance to develop and to use Alternative and Rapid Mic...

3 years ago 76 mins

Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century

Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro Biosystems

Today Pharmaceutical industry remains conservative for microbiology testing methods and has reluctance to develop and to use Alternative and Rapid Mic...

4 years ago 77 mins

Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and C

Dr. Michael J. Miller, President of Microbiology, LLC and Lori Daane Pharma Microbiology Scientific Director at bioMérieux

Full Title: Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products Gene and cell therapy products, also...

4 years ago 75 mins

Rapid Microbiology Applications in the COVID-19 Era

Dr. Michael J. Miller, Ulrich Herber and Lori Daane

The implementation of rapid microbiological methods (RMM) has gained significant momentum over the past few years. In particular, the ATMP segment has...

3 years ago 110 mins

Regulatory Approval of Three Rapid Microbiological Methods for MACI Release

John Duguid, Senior Director, at Vericel Corporation in Cambridge, and Nicola Reid, Senior Product Manager at Charles River

Title:Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release Rapid detection of contaminants is essential for cell therap...

5 years ago 65 mins

Changing the Paradigm: Moving to In-Process Release Testing

Presented by Scott Weiss, Johnson & Johnson and Lori Daane at bioMérieux

Changing the paradigm – moving to in-process release testing is a presentation to explore the possibilities of the future. We will discuss limitation...

3 years ago 77 mins

Just in Time Release of CAR T Cell Therapies

Irving Ford, Head of CAR T QC Laboratories at Celgene and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux

Presented by Irving Ford, Head of CAR T QC Laboratories at Celgene The views and opinions expressed during the Webinar are those of the presenter. C...

4 years ago 77 mins

Update of the IFU Method No.12 for Alicyclobacillus spp

Luis Costa, Field Marketing Manager LATAM, Millipore Sigma

Important updates to the IFU Method No. 12 for Alicyclobacillus. Spore-forming Thermo-acidophilic spoilage bacteria are one of the major frequent conc...

3 years ago 76 mins

Validation of Microbiological Methods - Expectations for Regulatory Compliance

Dr. Rajesh K. Gupta

Microbiological methods play a critical role in ensuring safety and efficacy of drugs and biologics. Most microbiological methods are described in com...

8 years ago 70 mins

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