Resources
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WCBP 2026 Scientific Program
Scientific Program: WCBP 2026
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Regulatory Considerations for Multispecific Antibody-Based Products for BLA and Beyond
Speaker Presentation: CMC Strategy Forum North America 2026
Swisher Jennifer, CDER. FDA, 2026 -
Ensuring Drug Product Content Meets Label Claim -- Are You Getting What You Paid For?
Speaker Presentation: CMC Strategy Forum North America 2026
Rivera Rosado Leslie, CDER, FDA, 2026 -
Late-Stage CMC Analytical Speed Bumps: When ‘Later’ is Suddenly Now…
Speaker Presentation: CMC Strategy Forum North America 2026
Ritter Nadine, Global Biotech Experts, LLC, 2026 -
Regulatory Considerations for Early-Stage Development of Bi-, Tri-, and Multi-Specific Therapeutics
Speaker Presentation: CMC Strategy Forum North America 2026
Parmar Hiren, Health Canada, 2026 -
Control Strategies Tailored for Multispecifics
Speaker Presentation: CMC Strategy Forum North America 2026
Ni Wenqin, Pfizer, Inc., 2026 -
Compendial Expectations for Dose Content and Uniformity for Biologics
Speaker Presentation: CMC Strategy Forum North America 2026
McCarthy Diane, US Pharmacopeia, 2026 -
Strategies for Successful Development and Manufacturing of Multi-Specific Antibodies and Proteins
Speaker Presentation: CMC Strategy Forum North America 2026
Chang Yuan, WuXi Biologics, 2026 -
Strategies for Analytical Characterization of Multi-Specific Proteins
Speaker Presentation: CMC Strategy Forum North America 2026
Auclair Jared, Northeastern University, 2026 -
CMC Strategy Forum North America 2026 Scientific Program
Scientific Program: CMC Strategy Forum North America 2026
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CMC Strategy Forum North America 2026 Summary Infographic
Summary Infographic: CMC Strategy Forum North America 2026
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WCBP 2026 Summary Infographic
Summary Infographic: WCBP 2026
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ICH Q1s/5C Revision – Opportunities in Science and Risk-Based Testing Approaches for Biologics
Speaker Presentation: CMC Strategy Forum Japan 2025
Zimmermann Boris, Genentech, a Member of the Roche Group, 2025 -
Workshop III Introduction
Speaker Presentation: CMC Strategy Forum Japan 2025
Workshop III Introduction -
rAAV as a Heterogeneous Particle Ensemble: Current Understanding of Its Quality Attributes
Speaker Presentation: CMC Strategy Forum Japan 2025
Uchiyama Susumu, Osaka University, 2025 -
Industry Perspective on Implementation of AI and Machine Learning in Manufacturing - Emerging Regulatory Landscape
Speaker Presentation: CMC Strategy Forum Japan 2025
Thurau Gert, F. Hoffmann-La Roche Ltd., 2025 -
ICH Q12 Implementation in Japan, and Current Situation of ICH M4Q(R2)
Speaker Presentation: CMC Strategy Forum Japan 2025
Tanaka Keisuke, PMDA, 2025 -
Regulatory Perspectives on Model-Informed Decision-Making to Support Biologic Drug Development and Market Applications
Speaker Presentation: CMC Strategy Forum Japan 2025
Siggers Jayda, Health Canada, 2025 -
Challenges and Approaches Related to Extrapolation and Shelf Life/re-Test Period Setting in Biological Products
Speaker Presentation: CMC Strategy Forum Japan 2025
Shibata Hiroko, National Institute of Health Sciences, 2025 -
Challenges of Manufacturing of AAV for Gene Therapy Products, Focusing on Upstream and Downstream Processes
Speaker Presentation: CMC Strategy Forum Japan 2025
Sakurai Takashi, Astellas Pharma Inc., 2025