Resources
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Regulatory Considerations for CAR T Cell Development
Speaker Presentation Schultz Kimberly, CBER, FDA, 2021
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Product and Process Characterization – The Data Sources for an Adequate Control Strategy
Speaker Presentation Gross Steffen, Paul-Ehrlich-Institut, 2021
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Justification of Specification & Life-cycle Management of Relevant Analytical Methods
Speaker Presentation Backofen Ulli, Boehringer Ingelheim, 2021
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Analytical Similarity Assessment for Biosimilar Initial Approval, Lifecycle Management, and Extrapolation of Indications
Speaker Presentation Liu Jennifer, Amgen Inc., 2021
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Comparability Exercise for Biologics: A Case Study
Speaker Presentation Chang Andrew, Novo Nordisk Inc., 2021
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Risk-based Comparability for Biological Products (Perspectives from a multi-national company)
Speaker Presentation Edwards Julia, Genentech, a Member of the Roche Group, 2021
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Application and Review: Trends in the Past Decade of Chinese Biopharmaceuticals
Speaker Presentation Wei Kaikun, Center for Drug Evaluation (CFDA), 2021
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The Criticality of Efficient CMC Changes Through the Product Lifecycle
Speaker Presentation Montgomery Frank, AstraZeneca, 2021
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Update of Q12 Implementation in Japan - China
Speaker Presentation Yagi Satomi, Kyowa Hakko Kirin Co. Ltd., 2021
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CMC Regulatory Expectations for Biological Therapeutic Products for Life Cycle Management and EUA Applications, a CDER/FDA Perspective
Speaker Presentation Jing Xianghong (Emily), CDER, FDA, 2021
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Strategies to Establish Release Specifications for Peptide Maps
CMC Summary Paper: CMC Strategy Forum North America Fall 2002
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Analysis and Structure Characterization of Monoclonal Antibodies
CMC Summary Paper: CMC Strategy Forum North America Winter 2003
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What Is Test Method Qualification?
CMC Summary Paper: CMC Strategy Forum North America Summer 2003
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Mycoplasma In-Process and Lot Release Test: To PCR Or Not To PCR
CMC Summary Paper: CMC Strategy Forum North America Fall 2003
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Life Cycle Approach to Setting Specifications for Biotechnology-Derived Products
CMC Summary Paper: CMC Strategy Forum North America Winter 2004
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Defining Your Product Profile and Maintaining Control Over It - Part 1 through 4
CMC Summary Paper: CMC Strategy Forum North America Summer 2004
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Lot Release and Characterization Testing of Live-Virus-Based Vaccine and Gene Therapy Products - Part 1 and 2
CMC Summary Paper: CMC Strategy Forum North America Winter 2005 - 2
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Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase and Post Approval
CMC Summary Paper: CMC Strategy Forum North America Winter 2005
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Design and Successful Implementation of a Stability Program for Biotechnology-Derived Products
CMC Summary Paper: CMC Strategy Forum North America Summer 2005
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Standard Reference Materials for Biopharmaceutical Products: Strategies to Support Product and Method Specifications
CMC Summary Paper: CMC Strategy Forum North America Summer 2006