Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date Points to consider when defining a microbial control strategy... Friedrich von Wintzingerode, PhD, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) Full title: Points to consider when defining a microbial control strategy for individualized ATMPs How are individualized ATMPs different from tradit... April 5, 2023 5:00pm 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... 3 weeks ago | 119 mins Annex 1 and Environmental Monitoring Program - Implementation And Justification. Benoit Ramond at Sanofi and Laurent Leblanc at bioMérieux Full Title: Annex 1 and Environmental Monitoring Program - Implementation And Justification of The Best Practices In Routine What is new? How to impl... 5 months ago | 118 mins Reducing Microbiological Risk & Using Quality Tools in the Pharma Industry Don Singer, GlaxoSmithKline R&D and Jessica Rayser, Product Manager at Charles River The pharmaceutical industry paradigm change is occurring and industry has taken an important leap towards formality of quality improvement using quali... 4 years ago | 55 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... 2 years ago | 77 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 Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay Ruth Daniels, Senior Scientist, Microbiology Expert, Janssen and Kevin Williams Microbiological Test Development, bioMérieux Presented by Dr. Ruth Daniels, Senior Scientist - Microbiology Expert at Janssen This webinar presentation will discuss: • Endotoxin hold time studi... 2 years ago | 68 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... 4 years ago | 65 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 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
