Resources
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Analytical Method Life Cycle Management and the Revised ICH Q2 and New ICH Q14
Roundtable 2 Notes: AT Europe 2019
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Analytical Challenges and Solutions of Therapeutics Beyond mAbs
Roundtable 1 Notes: AT Europe 2019
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Enhanced Analytical Development for Complex Antibody Formats
Speaker Presentation Wild Markus Roche 2017
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Structure-function of GP2015/Erelzi
Speaker Presentation Mayer Robert Sandoz 2017
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Modernizing the Platform Characterization Peptide Map for Accurate Assessment of Deamidation and Isomerization by LC-MS/MS
Speaker Presentation Marzilli Lisa Pfizer 2017
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Analytics for Complex Drugs: FDA Examples
Speaker Presentation Keire David FDA 2017
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Higher Order Structure: Route to QC testing?
Speaker Presentation Jone Carl UCB 2017
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Flow Induced Dispersion Analysis for Quantification of Proteins and Protein Ligand Interactions under Native Conditions
Speaker Presentation Jensen Henrik University of Copenhagen 2017
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Sequential Injection Capillary Electrophoresis for Bioprocess Monitoring
Speaker Presentation Guijt Rosanne UTAS 2017
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Is There a Need for a New Regulatory Pathway for Biologics?
Speaker Presentation Fauconnier Alan Belgian Medicines Agency (FAGG - AFMPS) 2017
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Application of Mass Spectrometric Methods
Speaker Presentation Cyr Terry Health Canada 2017
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Higher Throughput Glycosylation Analysis of Biopharmaceuticals by Mass Spectrometry
Speaker Presentation Wuhrer Manifred Leiden University Medical Center 2018
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Complexity of the Analytical Characterization of Polysorbate
Speaker Presentation Wuchner Klaus Janssen R&D 2018
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Towards the Use of Reaction-Modulators in an Integrated Multi-Dimensional Liquid Chromatography System
Speaker Presentation Wouters Bert University of Amsterdam 2018
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Regulatory Considerations When Developing Relevant and Sustainable Analytical Technologies
Speaker Presentation Swann Patrick Amgen 2018
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Role of the BWP
Speaker Presentation Ruiz Sol Spanish Medicines Agency (AEMPS) 2018
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Analytical Considerations for Excipients
Used in Biotechnology Products
Speaker Presentation Rao Ashutosh FDA 2018
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A Regulatory Perspective on Methods Used for Analytical Similarity Assessments
Speaker Presentation Nickens Kristen FDA 2018
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Challenges in Peptide Mapping Mass Spectrometry of Biopharmaceuticals
Speaker Presentation Burkitt Will UCB Pharma 2018
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Analytical Strategies to Monitor Polysorbate in Biotherapeutics
Speaker Presentation Bell Christian Roche 2018