Resources
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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
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Comparability Strategies for Autologous Genetically Modified Hematopoietic Stem Cells (GM-HSC)
Speaker Presentation Havert Michael Bluebird Bio 2020
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Alternative Monitoring Approaches for New Aseptic Fill Technologies for Individualized Therapies: Closed Gloveless Filling Isolators.
Speaker Presentation Glunz Alexander Genentech 2020
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Re-thinking Comparability Assessments for
Individualized Therapeutics
Speaker Presentation Francissen Kathy Genentech 2020
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Manufacturing Logistical and Capacity Considerations For Cell and Gene Therapy Products
Speaker Presentation Finn Thomas US FDA 2020
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Introduction to SARS-CoV-2 and COVID-19
Speaker Presentation Dormitzer Philip Pfizer 2020
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Relative Infectivity as a Reliable Alternative to the TCID50 Assay
Speaker Presentation Cheung Win Den REGENXBIO 2020