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Industry Feedback on FDA Comparability Guidance (Session 1)
Roundtable Session 1 - Table 2 Notes: CGTP 2024
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FDA Draft Guidance on Potency Assurance (Session 2)
Roundtable Session 2 - Table 3 Notes: CGTP 2024
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FDA Draft Guidance on Potency Assurance (Session 1)
Roundtable Session 1 - Table 3 Notes: CGTP 2024
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ATMP Raw/Starting Material Risk Assessments, Control Strategy and Regulatory Expectations (Session 2)
Roundtable Session 2 - Table 1 Notes: CGTP 2024
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ATMP Raw/Starting Material Risk Assessments, Control Strategy and Regulatory Expectations (Session 1)
Roundtable Session 1 - Table 1 Notes: CGTP 2024
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CGTP Summit 2024 Scientific Program
Scientific Program: CGTP Summit 2024
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CGTP 2024 Scientific Program
Scientific Program: CGTP 2024
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CGTP 2024 Summary Infographic
Summary Infographic: CGTP 2024
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CGTP Summit 2024 Summary Infographic
Summary Infographic: CGTP Summit 2024
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Workshop Practical Applications for Method Design and Performance
Speaker Presentation Workshop Santoro Colleen and Stauffer Tara, Bristol-Myers Squibb Company -
Lumit® dsRNA Detection Assay
Speaker Presentation Vendor Showcase by Promega Corporation
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Are you Still Growing Cells for your Bioassay?
Speaker Presentation Vendor Showcase by acCELLerate GmbH
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Regulatory Considerations of Bioassay Lifecycle Management For Biologics
Speaker Presentation Boone Leiyun FDA 2024
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Potency Assurance for Cellular and Gene Therapy Products
Speaker Presentation Byrnes Andrew CBER, FDA 2024
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Meaningful Bioassays to Elucidate Structure-Function and Demonstrate Control
Speaker Presentation Santoro Colleen Bristol-Myers Squibb Company 2024
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Lessons Learned for Potency Assays for Biospecific mAbs for Accelerated Programs
Speaker Presentation Hayes Marianne Johnson & Johnson 2024
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Gains and Losses Regarding the Harmonization of Specifications during the COVID-19 Pandemic: Science Versus the Fear Factor
Speaker Presentation Smith Dean Health Canada 2024
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Best Practices, Strategies & Utilization of Novel Biological Responses for Robust Cell-Based Potency Assays
Speaker Presentation Morales Pedro Catalent Biologics 2024
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Assay Development Within the Field of AAV Therapies; Engineering iLite® Cell Lines for Specific and Analytical Applications
Speaker Presentation Morera Jordi Rodó Svar Life Science 2024
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Assay Development and Concept Verification of a Trispecific Antibody
Speaker Presentation Mizuno Yuri Chugai Pharmaceutical Co., Ltd. 2024