Resources
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Bioassays in Product Development: An Immuno-Oncology Perspective
Speaker Presentation Stauffer Tara Bristol-Myers Squibb 2017
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Setting up Acceptance Criteria with the Application of Equivalence Test and Geometric Mean Following USP Chapters -A Cell-based Potency Assay Case Study
Speaker Presentation Shi Liming Pfizer 2017
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Comparative Analytical Method Transfer - Setting Acceptance Criteria
Speaker Presentation Rugaiganisa Andrew Pfizer 2017
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Development of Generic Goal Posts for Equivalence Testing of Potency Assay Methods
Speaker Presentation Pflanzner Thorsten AbbVie 2017
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Bioassay Method Transfer: Regulator’s Perspective and Case Studies
Speaker Presentation Nemec Martin Health Canada 2017
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Antibody-Mediated Effector
Function: Learning and
Challenges from Early
Discovery to Development
Speaker Presentation Mehta Payal Eli Lilly & Company 2017
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Expectations for Bioassays - An Assessor's View
Speaker Presentation Jost Nils Paul Ehrlich Institut 2017
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Biological Activity Testing - Regulatory Considerations
Speaker Presentation Bower Hoefnagel Marcel Medicines Evaluation Board 2017
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Automation Friendly Assay Design
Speaker Presentation Bower Hepler Christopher Catalent 2017
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Tier 1 Biosimilarity Assessments – A Practical Illustration
Speaker Presentation Bower Keith University of Washington 2017
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Use of Echo® Liquid Handlers to Improve the Efficiency and Reliability of Bioassay Laboratories
Speaker Presentation Allison Tim Labcyte 2017
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Phase-Specific Control Strategy Considerations for Cell and Gene Therapy Products – a Canadian Perspective
Speaker Presentation Storbeck Christopher Health Canada 2020
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Label-free Single Cell Analysis to Monitor Cell Development and Surveil Quality of ATMP Products
Speaker Presentation Schütze Karin CellTool 2020
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Management of Manufacturing Changes and
Comparability of Cellular and Gene Therapy
Products
Speaker Presentation Salz Tal US FDA 2020
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A Risk-Based Approach to the Implementation of a Control Strategy for Advanced Therapy Medicinal Products
Speaker Presentation Pillsbury Darius ValSource 2020
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Challenges with Cell Based Medicines in the EU
Speaker Presentation Menezes Ferreira Margarida 2020
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CMC Challenges During Accelerated Development of Human Cell & Gene Therapy Products - A CBER Perspective
Speaker Presentation Kwilas Anna US FDA 2020
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Usage of an mRNA Platform Technology for “Light Speed” Development of a Vaccine Against SARS-CoV-2
Speaker Presentation Kuhn Andreas Biontech 2020
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INO-4800: One SARS-CoV-2 Vaccine, One Decade of Innovation
Speaker Presentation Juba Rob Inovio 2020
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CMC Considerations for Accelerated Development of ATMP
Speaker Presentation Hoefnagel Marcel Medicines Evaluation Board 2020