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Potency Assurance for Cellular and Gene Therapy Products
Speaker Presentation Byrnes Andrew CBER, FDA 2024 -
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
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Apples and Oranges,- Case Studies on Similarity, Comparability and Equivalence Regarding Potency Determination
Speaker Presentation Beck Hermann F. Hoffmann-La Roche Ltd. 2024
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Workshop Introduction to Bioassay Development
Speaker Presentation Workshop Introduction to Bioassay Development
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Utilizing HiBiT TCK Bioassays To Validate Cell Therapy & mAb-Mediated Immunotherapy Potency
Speaker Presentation Hess Nicholas Promega Corporation 2024
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Adapting CMC Bioassay Strategies in Response to an Evolving ADC Pipeline
Speaker Presentation Hussman Patrick AstraZeneca 2024
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Bioassays 2024 Scientific Program
Scientific Program: Bioassays 2024
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Bioassays 2024 Summary Infographic
Summary Infographic: Bioassays 2024
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When Simulation is Not Enough - When and Why Are Real World Studies of Shipping Needed
Roundtable 8 Notes: WCBP 2024
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Visible and Sub-visible Particles - New Approaches and Requirements
Roundtable 18 Notes: WCBP 2024
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Unlocking the Genetic Code - NGS Marvels in the Realm of Cell Therapy
Roundtable 21 Notes: WCBP 2024
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Technical Transfer of Analytical Procedures - Approaches for Streamlining and Discussion of Regulatory Submissions Experiences
Roundtable 10 Notes: WCBP 2024
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Supply Issues of New Medicines – Focus on Equitable Access in Third World Countries
Roundtable 12 Notes: WCBP 2024
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Setting Specifications on Limited Data, Clinically Relevant Specs - Next Generation Control Strategies - Looking Ahead to Revision of ICH Q6B
Roundtable 1 Notes: WCBP 2024
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Setting Specifications on Limited Data Clinically Relevant Specs - Next Generation Control Strategies - Looking Ahead to Revision of ICH Q6B - What is Needed
Roundtable 1 Notes: WCBP 2024