Resources
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CMC North America 2022 Scientific Program
Scientific Program: CMC North America 2022
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Svar Life Science - Vendor/Technical Presentation
Speaker Presentation Schwenkert Michael Svar Vendor 2022
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Bioassays Throughout Drug Development and
the Product Life Cycle
Speaker Presentation Shapiro Marjorie CDER FDA 2022
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HiBiT: A Tiny Tag to Assess MOA-based CAR-T Cell Potency
Speaker Presentation Cong Mei Promega 2022
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Characterization of Dual AAV Vector Otoferlin
Speaker Presentation Le Bec Christine Sensorion 2022
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From Bioassay Method Development to Commercial Testing at Pandemic Speed: the Story of AZD1222 (ChAdOx1 nCoV-19)
Speaker Presentation Umlauf Scott AstraZeneca 2022
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Challenges of Developing Potency Assays for Critical Materials Used in Cell and Gene Therapy Products
Speaker Presentation Dios Amanda Beam Therapeutics Inc. 2022
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A Better Understanding of Bioassays: How Suitable are Primary Cell Based Assays for the Evaluation of Product Quality?
Speaker Presentation Cymer Florian F. Hoffmann-La Roche Ltd 2022
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Universal Assay to Measure CAR T Cell Potency
Speaker Presentation Bambad Cynthia Minerva Biotechnologies 2022
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Manufacturing Challenges and Strategies for Bispecific Antibody
Speaker Presentation Wu Wen Jin CDER, FDA 2022
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Expectations on Potency Assays for Antibody-based Novel Modalities– a Regulatory Perspective
Speaker Presentation Zhang Nailing CDER, FDA 2022
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A Potent Solution to a
Low Affinity Problem
Speaker Presentation Wilson Morgan INHIBRX 2022
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Characterization of Novel Biological Product Modalities - A Regulatory Perspective
Speaker Presentation Rivera Rosado Leslie CDER, FDA 2022
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Novel Modalities May Warrant Novel Product Quality Controls
Speaker Presentation Schmiel Deborah CDER, FDA 2022
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Cell-Based Potency Assay : Designs and Considerations
Speaker Presentation Kumar Janani Molecular Templates, Inc. 2022
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Leveraging a Novel Flexible Facility Concept to Provide Solutions to Current and Future Manufacturing Challenges
Speaker Presentation Christy Charles Lonza 2022
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Bioassays 2022 Summary Infographic
Summary Infographic: Bioassays 2022
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CMC Strategy Forum North America 2022 Summary Infographic
Summary Infographic: CMC Strategy Forum North America 2022
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CMC Strategies for Expedited Program Development — Regulatory Perspectives
CMC Summary Paper: CMC Strategy Forum North America Fall 2020
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Cell & Gene Therapy Products 2022 Summary Infographic
Summary Infographic: Cell & Gene Therapy Products 2022