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 Contamination Control Challenges Facing Cell Therapy Facilities Conor McMorrow at Takeda and Félix Montero-Julian at bioMérieux The presentation aims to provide an overview of challenges that can be faced with the knowledge that a one size fits all approach cannot be taken. Whi... 1 month ago | 101 mins Harmonized Manufacturing Network For Sterility Assurance Frederic Ayers at Eli Lilly and Company, Martell Winters at Nelson Labs and John Schlect at Sterigenics This presentation will provide an understanding related to Global Guidance related to holistic Contamination Control Strategies. The importance of cr... 4 months ago | 142 mins Considerations For Sterility Test Methods When Working With CDMOs Miriam Guest at AstraZeneca, Anne Weeks at Merck KGaA and Chris Berridge at Ecolab The confirmation of microbial quality of drug products manufactured by contract manufacturing organisations (CMOs) is a key component of product relea... September 14, 2023 2:00pm Regulatory Strategies For Rapid Sterility Testing... Dr. Michael J. Miller, at Microbiology Consultants, LLC and Lori Daane, at bioMérieux Full Title: Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products The need to utilize rapid sterility testing is gainin... 1 year ago | 122 mins Rapid methods- The Next Phase : A Framework For Multi-Product Adoption... Miriam Guest, at AstraZeneca UK and Ulrich Herber at Charles River Full Title: Rapid methods- The Next Phase : A Framework For Multi-Product Adoption Of Rapid Sterility Testing The adoption of rapid sterility testing... 1 year ago | 120 mins We Are Going Back to the Future with Rapid Methods Dr. Michael J. Miller, at Microbiology Consultants, LLC and Félix Montero-Julian, Scientific Director at bioMérieux Rapid methods have been available to the pharmaceutical industry for decades. And although global regulations have changed to encourage their use, esp... 1 year ago | 111 mins Rapid methods- The Next Phase : A Framework For Multi-Product Adoption... Miriam Guest, at AstraZeneca UK and Ulrich Herber at Charles River Full Title: Rapid methods- The Next Phase : A Framework For Multi-Product Adoption Of Rapid Sterility Testing The adoption of rapid sterility testing... 1 year ago | 120 mins Just in Time Release of CAR T Cell Therapies During Covid-19 Irving Ford at Bristol Myers Squibb and Lori Daane at bioMérieux Presented by Irving Ford, Site QA Head multi-product CAR T facility at Bristol Myers Squibb 1 year ago | 78 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 Current USP Perspectives on a Rapid Sterility Test Dr David Roesti, Novartis/USP and Erin Patton, Charles River The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under t... 5 years ago | 65 mins
