Resources

Home / Resources

Quality by Design (QbD) for Biopharmaceuticals
CMC Summary Paper: CMC Strategy Forum North America Summer 2007
Extractables and Leachables: Challenges and Strategies in Biopharmaceutical Development
CMC Summary Paper: CMC Strategy Forum North America Winter 2008
Raw Material Control Strategies for Bioprocesses
CMC Summary Paper: CMC Strategy Forum North America Winter 2009
Practical Applications of Quality Risk Management
CMC Summary Paper: CMC Strategy Forum North America Summer 2009
The Role of Higher Order Structure in Defining the Quality of Biopharmaceutical Products
CMC Summary Paper: CMC Strategy Forum North America Winter 2010 - 2
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
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
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
Challenges and Considerations for Multiproduct Facility Design and Control for Biologics
CMC Summary Paper: CMC Strategy Forum North America Summer 2011
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
Biosimilar Products: Scientific Principles, Challenges, Opportunities
CMC Summary Paper: CMC Strategy Forum North America Winter 2012
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
CMC Summary Paper: Practical Use of Expanded Change Protocols
CMC Summary Paper: CMC Strategy Forum North America Winter 2013 - 2
Neoantigen Specific Therapies (NESTs), Pushing Boundaries While Toeing the Line!
Speaker Presentation Alla Ravi, Genentech, a Member of the Roche Group, 2021
Paradigms for Process Validation - A Practical Approach
CMC Summary Paper: CMC Strategy Forum North America Winter 2013
Biological Product-specific Reference Standard - Best Practices - Part 1 and 2
CMC Summary Paper: CMC Strategy Forum North America Summer 2013
Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations
CMC Summary Paper: CMC Strategy Forum North America Winter 2014 - 2
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
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
Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification: Technical and Regulatory Considerations
CMC Summary Paper: CMC Strategy Forum North America Summer 2015