Resources
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Non-Traditional Approaches to Comparability
Roundtable Notes: Session 1 Table 3 CGTP 2025
Non-Traditional Approaches to Comparability -
Donor Selection Criteria Across ICH Regions
Roundtable Notes: Session 1 Table 2 CGTP 2025
Donor Selection Criteria Across ICH Regions -
Potency Assurance Strategies for Cell and Gene Therapies
Roundtable Notes: Session 1 Table 1 CGTP 2025
Potency Assurance Strategies for Cell and Gene Therapies -
Ensuring Product Comparability in Cell Therapy: Approach to Managing Multifactorial Changes
Speaker Presentation: CGTP 2025
Sachamitr Patty, BlueRock Therapeutics LP, 2025 -
Challenges in Getting Genome Editing Medicines into the Clinic
Speaker Presentation: CGTP 2025
Ramsey Phillip, Sangamo Therapuetics, Inc., 2025 -
Transparency-Driven Partnerships for Shared Success – iPSC Journey
Speaker Presentation: CGTP 2025
Pedro Castanho Vaz, Catalent, 2025 -
Developing and Deploying N-of-1 Gene-Editing Therapies
Speaker Presentation: CGTP 2025
Musunuru Kiran, University of Pennsylvania, 2025 -
Investigating the Aggregation, Genome Release, and Self-Interactions of Adeno-Associated Virus Formulations
Speaker Presentation: CGTP 2025
Motabar Lily, University of Delaware, 2025 -
Considerations in Development, Characterization, and Commercialization of Platform Processes
Speaker Presentation: CGTP 2025
Madaras Stephen, Miltenyi Biotec, 2025 -
A Single, Ready-to-Use Kit for Fast, Comprehensive Analysis of Both Plasmid Topological Isoforms and Linear Sizing on a Multi-Capillary Electrophoresis Platform
Speaker Presentation: CGTP 2025
Li Tingting, SCIEX, Kang Henry, SCIEX, 2025 -
Healthy Donor Cells Compared to SCD and TDT Patient Cells in Casgevy Process: Performance and Product Quality
Speaker Presentation: CGTP 2025
Kadiyala Irina, Vertex Pharmaceuticals Incorporated, 2025 -
ATMP Activities at MEB
Speaker Presentation: CGTP 2025
Hoefnagel Marcel, Medicines Evaluation Board, 2025 -
INS1203: RNA-End Joining Technology Enables A Dual AAV Approach for ABCA4 Gene Replacement in Stargardt Disease
Speaker Presentation: CGTP 2025
Hilde Kathryn, Insmed Incorporated, 2025 -
Lipid Nanoparticles-Points to Consider For Non-Viral Delivery of RNA-based Therapeutics
Speaker Presentation: CGTP 2025
Heidaran Mo, Cellx Consulting, 2025 -
Optimizing Analytical Release Testing Through Reduced Volume and Turn-around Times
Speaker Presentation: CGTP 2025
Giffin Michael, ElevateBio, 2025 -
Anticipating the
Exceptional Release
Bottleneck
Speaker Presentation: CGTP 2025
Eisenstatt Jessica, AstraZeneca, Preville Yoonji, AstraZeneca, 2025 -
Integrating Process and Analytics: A Prerequisite to Streamlining the Production of Viral Vectors
Speaker Presentation: CGTP 2025
Deb Amitabha, CellGene Consulting LLC, 2025 -
CRISPR Genome Editing Components Used for Ex-Vivo Genome-Editing of Allogeneic Cell Therapy Products: Their Clearance and Their Effects
Speaker Presentation: CGTP 2025
Chialastri Alex, Century Therapeutics, 2025 -
Beyond “One Disease at a Time” : Genetic Therapy Platforms for Rare Monogenic Disease
Speaker Presentation: CGTP 2025
Brooks Philip J., NIH, 2025 -
Recent Regulatory Advancements on Cell and Gene Therapy Products in Japan
Speaker Presentation: CGTP 2025
Atsushi Nishikawa, PMDA, 2025