Resources
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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
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Biological Product-specific Reference Standard - Best Practices - Part 1 and 2
CMC Summary Paper: CMC Strategy Forum North America Summer 2013
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Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations
CMC Summary Paper: CMC Strategy Forum North America Winter 2014 - 2
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Accelerated Product Development - Leveraging Combined Industry and Regulator Knowledge to Bring Products to Patients More Quickly
CMC Summary Paper: CMC Strategy Forum North America Winter 2014
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Effective Management of Contract Organizations: Sponsors, Contract Organizations, Health Authorities and Patients - Keeping the Product Pipeline Moving, Compliant and Available
CMC Summary Paper: CMC Strategy Forum North America Summer 2014
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Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification: Technical and Regulatory Considerations
CMC Summary Paper: CMC Strategy Forum North America Summer 2015
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Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
CMC Summary Paper: CMC Strategy Forum North America Summer 2016
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Production Cell Line Development and Control of Product Consistency during Cell Cultivation - Myths, Risks and Best Practices
CMC Summary Paper: CMC Strategy Forum North America Summer 2017
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The Development of Patient-Focused Commercial Specifications Through Understanding of Clinical Relevance and Criticality of Quality Attributes
CMC Summary Paper: CMC Strategy Forum North America Winter 2019
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More Structured, Interactive Process to Drive Convergence in Latin America Advocated by Biotech Product Regulators and Industry at CMC Strategy Forum in Brasilia
CMC Summary Paper: CMC Strategy Forum Latin America 2015
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