Resources
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“Catch Me if You Can” Analytical Considerations for the Control of Multi-Specific Antibody (MsAb) Homodimer Impurities
Speaker Presentation: CMC Strategy Forum North America 2025
Zhang Fang, Pfizer, Inc., 2025 -
Navigating the Regulatory Landscape for Multispecifics & Bioconjugates
Speaker Presentation: CMC Strategy Forum North America 2025
Yeung Angela, Health Canada, 2025 -
Regulatory Considerations in the Design, Development and Quality of Monoclonal Antibodies and Related Novel Antibody-Based Products
Speaker Presentation: CMC Strategy Forum North America 2025
Shapiro Marjorie, CDER, FDA (Retired), 2025 -
Control Strategies for Radiobioconjugates
Speaker Presentation: CMC Strategy Forum North America 2025
Raghunandan Gowri, Fusion Pharma, 2025 -
A QbD Approach for Analytical Comparability of ADC Molecule
Speaker Presentation: CMC Strategy Forum North America 2025
Liu Ally, Gilead Sciences, Inc., 2025 -
The “5C” Network of Linker-Payloads: Chemistry, Conjugation, Characterization, and Control of the Cytotoxic Intermediate
Speaker Presentation: CMC Strategy Forum North America 2025
Kovacs Ernest, Immunome Inc., 2025 -
CMC Considerations For Bioconjugates and Multispecifics: A Regulator′s Perspective
Speaker Presentation: CMC Strategy Forum North America 2025
Goto Kanoko, Pharmaceuticals and Medical Devices Agency (PMDA), 2025 -
Antibody-Drug Conjugates: Regulatory Insights and Lessons Learned
Speaker Presentation: CMC Strategy Forum North America 2025
Duncan Katharine K, GlaxoSmithKline, 2025 -
From Complexity to Clarity: Chile's Regulatory Vision for Bioconjugates & Multispecifics
Speaker Presentation: CMC Strategy Forum North America 2025
Canales Jorge, Public Health Institute of Chile, 2025 -
CMC Strategy Forum North America 2025 Summer Scientific Program
Scientific Program: CMC Strategy Forum North America 2025 Summer
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CMC Strategy Forum North America 2025 Summer Summary Infographic
Summary Infographic: CMC Strategy Forum North America 2025 Summer
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CGTP 2025 Summary Infographic
Summary Infographic: CGTP 2025
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Use of New Rapid Sterility Testing Methods – Successes and Challenges
Roundtable Notes: Session 1 Table 8 CGTP 2025
Use of New Rapid Sterility Testing Methods – Successes and Challenges -
Setting Specifications for Autologous CAR-T Cell Products
Roundtable Notes: Session 1 Table 6 CGTP 2025
Setting Specifications for Autologous CAR-T Cell Products -
Global Health Equity in Cell and Gene Therapy
Roundtable Notes: Session 2 Table 10 CGTP 2025
Global Health Equity in Cell and Gene Therapy -
Cost Drivers
Roundtable Notes: Session 2 Table 7 CGTP 2025
Cost Drivers -
Non-Traditional Approaches to Comparability (Session 2)
Roundtable Notes: Session 2 Table 3 CGTP 2025
Non-Traditional Approaches to Comparability (Session 2) -
Potency Assurance Strategies
Roundtable Notes: Session 2 Table 1 CGTP 2025
Potency Assurance Strategies -
Phase Appropriate Engineering Run Approaches and Stability
Roundtable Notes: Session 2 Table 5 CGTP 2025
Phase Appropriate Engineering Run Approaches and Stability -
Multiplex Approaches to Analytical Platforms for CGT Release
Roundtable Notes: Session 1 Table 4 CGTP 2025
Multiplex Approaches to Analytical Platforms for CGT Release