Resources
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Analytical Comparability for Autologous CAR-T Products
Speaker Presentation Yue Hai, Bristol-Myers Squibb Company, 2024 -
Comparability Study Considerations in the Development and Approval of AMTAGVI (lifileucel)
Speaker Presentation Natarajan Arvind, Iovance Biotherapeutics, 2024
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Comparability Considerations when In-Licensing an Early-Stage Academic Program
Speaker Presentation Chiu Annie, CARGO Therapeutics, 2024
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Advancing Stem Cell Therapy Development - Overcoming Challenges and Expanding Horizons
Roundtable Session 2 – Table 7 Notes: CGTP 2024
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Platform Applications Outside of AAV Gene Therapy Field
Roundtable Session 1 – Table 9 Notes: CGTP 2024
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QbD Tools for MAbs Don't Quite Work for CGT Products
Roundtable Session 2 - Table 8 Notes: CGTP 2024
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Process Validation Approaches for Complex Modalities
Roundtable Session 1 - Table 8 Notes: CGTP 2024
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Non-Viral Delivery Options for Cell-based Gene Therapy Products
Roundtable Session 1 - Table 7 Notes: CGTP 2024
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Material Classification for Genome Editing Components
Roundtable Session 1 - Table 5 Notes: CGTP 2024
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ICH M4Q CTD Structure - Considerations for ATMPs - Industry Experience and Challenges
Roundtable Session 2 - Table 4 Notes: CGTP 2024
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GMO Environmental Risk Assessment and the Application Process
Roundtable Session 2 - Table 6 Notes: CGTP 2024
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Facility Expansion - Scale-out (as opposed to scale up) - is Much More Common in the CGTP Space
Roundtable Session 2 - Table 5 Notes: CGTP 2024
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Detection of Particulates - Visual Inspection of CGT Products
Roundtable Session 1 - Table 4 Notes: CGTP 2024
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Creative Approaches to Stability Assessment for Frozen Products
Roundtable Session 1 - Table 6 Notes: CGTP 2024
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Best Practices in CMC Decision-Making (Clinical Phase)
Roundtable Session 2 - Table 10 Notes: CGTP 2024
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ATMPs and Companion Diagnostics - Development Challenges
Roundtable Session 2 - Table 9 Notes: CGTP 2024
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Industry Feedback on FDA Comparability Guidance (Session 2)
Roundtable Session 2 - Table 2 Notes: CGTP 2024
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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