Resources
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Asian Agencies Report on Progress in Addressing Emerging Regulatory Challenges at CASSS Biotech CMC Strategy Forum in Japan
CMC Summary Paper: CMC Strategy Forum Japan 2014
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Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum
CMC Summary Paper: CMC Strategy Forum Japan 2013
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Better Glycosylation Understanding Would Further International Biotech Regulatory Convergence Efforts, CMC Strategy Forum Participants Agree
CMC Summary Paper: CMC Strategy Forum Japan 2012
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COVID-19 Vaccine Urgency Throws Spotlight on Next-Generation Sequencing for Adventitious Virus Control Europe
CMC Summary Paper: CMC Strategy Forum Europe 2020
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EMA’s Draft Guideline on Drug-Device Combinations Sheds Needed Light on Expectations for Device Assessment
CMC Summary Paper: CMC Strategy Forum Europe 2019
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CMC Priorities of EFPIA’s European Biopharmaceutical Enterprises Include ADCs, Drug/Device Combos and Statistics
CMC Summary Paper: CMC Strategy Forum Europe 2018
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Accelerated Development and Review Initiatives in Focus at 2016 CASSS CMC Strategy Forum Europe
CMC Summary Paper: CMC Strategy Forum Europe 2016
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Amgen “Analytics of the Future” Initiative Develops MS-based “Multi-Attribute Methodology” to Streamline Biotech Development and QC Testing
CMC Summary Paper: CMC Strategy Forum Europe 2014
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EMA's Key Biotech Quality Initiatives in Focus at CASSS' 2012 CMC Strategy Forum Europe
CMC Summary Paper: CMC Strategy Forum Europe 2012
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Improving Biopharmaceutical Product Quality: Moving Implementation Forward
CMC Summary Paper: CMC Strategy Forum Europe 2011
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Challenges Facing Biopharmaceutical Development in the Next Decade
CMC Summary Paper: CMC Strategy Forum Europe 2010
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Increased EMA/Industry Dialogue Needed to Address Upcoming Biopharm Regulatory Challenges, Retiring Quality Director Purves Says
CMC Summary Paper: CMC Strategy Forum Europe 2010 - 2
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Protein Quality and Binding Affinities by Affinity CE and 2-dimensional Separations
Speaker Presentation Wätzig Hermann, University of Braunschweig, 2020
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Tapping Into New Applications Using Automated Protein Mass Spectrometry
Speaker Presentation Völger Hans-Rainer, Roche Diagnostics GmbH, 2020
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Analytical Characterization of Polysorbate 80
Speaker Presentation Sequeira Sara, Hovione Lumiar, 2020
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Mass Spectrometric Characterization of iCIEF-separated Antibody Charge Variants
Speaker Presentation Schlecht Johannes, Aalen University, 2020
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Novel High-Throughput Assay for Polysorbate Quantification in Biopharmaceutical Products by Using the Fluorescent Dye DiI
Speaker Presentation Menzen Tim, Coriolis Pharma Research GmbH, 2020
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Proteoform-resolved Structure-function Relationship Studies of Monoclonal Antibodies by FcɣRIIIa Affinity Liquid Chromatography-Native Mass Spectrometry
Speaker Presentation Lippold Steffen, Leiden University Medical Center, 2020
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FIDA for Protein Characterization in 3D: Size, Folding, and Functional Assessment in a Unified Approach
Speaker Presentation Jensen Henrick, University of Copenhagen, 2020
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Biopharmaceutical Affinity Profiling of Antibody and Antibodydrug-conjugate Preparations by On-line Post-column Surface Plasmon Resonance Biosensing & Mass Spectrometry
Speaker Presentation Kool Jeroen, Vrije Universiteit Amsterdam, 2020