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Considerations For Sterility Test Methods When Working With CDMOs

Sophie Drinkwater 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...

2 weeks ago 115 mins

Implementation of a Fully Automated & Integrated Continuous Biomanufacturing

Irina Ramos at AstraZeneca and Britta Anderson at Merck

Development and Implementation of a Fully Automated and Integrated System to Enable Continuous Biomanufacturing for Clinical Scale There are many exc...

2 weeks ago 100 mins

Design of a Global Sterility Assurance Program

Liz Brockson, Aseptic Processing and Sterility Assurance Lead in Global Sterility Assurance and Microbiology at Takeda

Sterility Assurance is an essential component of a contamination control strategy for aseptic processes and manufacturers of sterile products. With th...

November 15, 2023 3:00pm

Capabilities Development for Sterile Manufacturing

Dr Mauro Giusti, Senior Director, Site External Network at Eli Lilly & President, PDA Italy Chapter

Eli Lilly realized that the professionals (chemists, pharmacists, engineers, biologists, biotechnologists, etc) in charge of the Flow Teams and Proces...

3 weeks ago 44 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...

8 months ago 142 mins

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...

5 months ago 101 mins

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...

2 years 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

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

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

2 years ago 78 mins

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