Resources
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Rational Setting of Vector Copy Numbers in Genetically Modified Cells
Roundtable 10 Notes: Cell & Gene Therapy Products 2022
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Starting and Raw Materials -Harmonization Challenges, Testing and Control Requirements, etc.
Roundtable 9 Notes: Cell & Gene Therapy Products 2022
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Phase-appropriate Method Validation
Roundtable 8 Notes: Cell & Gene Therapy Products 2022
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Developing Process Analytical Technologies (PAT) to Support Advances in Cell Therapy Manufacturing
Roundtable 7 Notes: Cell & Gene Therapy Products 2022
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Characterization of CAR-T Cell Products – Challenges and Opportunities
Roundtable 6 Notes: Cell & Gene Therapy Products 2022
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Challenges with Emerging Technologies for CGTP Manufacturing and Single Sourcing
Roundtable 5 Notes: Cell & Gene Therapy Products 2022
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The Balance Between "Phase Appropriate Specifications" and Preparation for Marketing Authorization in Accelerated Development - Lessons Learned
Roundtable 4 Notes: Cell & Gene Therapy Products 2022
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Bridging Strategies for Manufacturing and CQA Assay Changes Moving from Phase 1 to Phase 2
Roundtable 3 Notes: Cell & Gene Therapy Products 2022
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Comparability Considerations for ATMPs
Roundtable 1 Notes: Cell & Gene Therapy Products 2022
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AT Europe 2022 Summary Infographic
Summary Infographic: AT Europe 2022
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Cell & Gene Therapy Products 2022 Scientific Program
Scientific Program: Cell & Gene Therapy Products 2022
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AT Europe 2022 Scientific Program
Scientific Program: AT Europe 2022
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Advanced Therapeutic Products - An Introduction to Health Canada’s Approach
Speaker Presentation Rosu-Myles Michael Health Canada 2022
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Overview of Genome Editing Products and
CMC Considerations
Speaker Presentation Ramsey Phillip Sangamo Therapeutics 2022
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Control of Allogeneic Donor Cells and Characterization: Integrating into Cell Therapy Regulatory Strategy
Speaker Presentation McCord Amy Takeda Pharmaceuticals 2022
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Product Development and Manufacturing of
oRNA™ Therapies
Speaker Presentation Maynor Benjamin Orna Therapeutics 2022
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FDA’s Efforts to Facilitate the Development of Cell and Gene Therapies
Speaker Presentation Marks Peter CBER FDA 2022
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Indian Canvas of Cell & Gene Therapy
Speaker Presentation Jotwani Geeta Indian Council of Medical Research 2022
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Cell Therapy Technology Transfer Approach and Challenges
Speaker Presentation Gelinas Peter ElevateBio 2022
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Capacity Planning Considerations for Autologous Cell Therapies
Speaker Presentation Collins Alicia Bristol-Myers Squibb Company 2022