Resources
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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
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Glycosylation of Therapeutic Proteins: Current Understanding of Structure-Function Relationship
CMC Summary Paper: CMC Strategy Forum North America Winter 2007 - 2
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Binding Assays and Bioassays: What Are Their Roles in Lot Release and Stability Testing?
CMC Summary Paper: CMC Strategy Forum North America Winter 2007
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Quality by Design (QbD) for Biopharmaceuticals
CMC Summary Paper: CMC Strategy Forum North America Summer 2007
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Extractables and Leachables: Challenges and Strategies in Biopharmaceutical Development
CMC Summary Paper: CMC Strategy Forum North America Winter 2008
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Raw Material Control Strategies for Bioprocesses
CMC Summary Paper: CMC Strategy Forum North America Winter 2009
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Practical Applications of Quality Risk Management
CMC Summary Paper: CMC Strategy Forum North America Summer 2009
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The Role of Higher Order Structure in Defining the Quality of Biopharmaceutical Products
CMC Summary Paper: CMC Strategy Forum North America Winter 2010 - 2
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Analytical Characterization and Regulatory Considerations for Antibody-Drug Conjugates: Uniting Small Molecule and Biologic Drug Perspectives
CMC Summary Paper: CMC Strategy Forum North America Winter 2010
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QbD for Biologics: Learning's from the Product Development and Realization Case Study (A-Mab) and the FDA OBP Pilot Program
CMC Summary Paper: CMC Strategy Forum North America Summer 2010
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A Practical Approach to the Analysis and Immunogenic Potential of Aggregates and Particles - Part 1 and 2
CMC Summary Paper: CMC Strategy Forum North America Winter 2011
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Challenges and Considerations for Multiproduct Facility Design and Control for Biologics
CMC Summary Paper: CMC Strategy Forum North America Summer 2011
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CMC Summary Paper: Rapid Pharmaceutical Product Development: Getting Off the Critical Path and onto the Right Path
CMC Summary Paper: CMC Strategy Forum North America Winter 2012 - 2
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Biosimilar Products: Scientific Principles, Challenges, Opportunities
CMC Summary Paper: CMC Strategy Forum North America Winter 2012
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Drug Product for Biological Medicines: Novel Delivery Devices, Challenging Formulations and Combination Products - Part 1 and 2
CMC Summary Paper: CMC Strategy Forum North America Summer 2012
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CMC Summary Paper: Practical Use of Expanded Change Protocols
CMC Summary Paper: CMC Strategy Forum North America Winter 2013 - 2
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Neoantigen Specific Therapies (NESTs), Pushing Boundaries While Toeing the Line!
Speaker Presentation Alla Ravi, Genentech, a Member of the Roche Group, 2021
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Paradigms for Process Validation - A Practical Approach
CMC Summary Paper: CMC Strategy Forum North America Winter 2013