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Phase Dependent Requirements for Method Validation Across the Globe
Roundtable 6 Notes: AT Europe 2018
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Analysis of Polysorbate and Its Degradation Products
Roundtable 5 Notes: AT Europe 2018
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How to Translate Physicochemical Properties into Claims of Safety and Efficacy
Roundtable 4 Notes: AT Europe 2018
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Setting Specifications with Limited Batches and Analytics to Understand Process and Assay Variability
Roundtable 3 Notes: AT Europe 2018
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Charge Variants Analysis (cIEF/icIEF, IEC, CZE)
Roundtable 2 Notes: AT Europe 2018
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Mass Spec in QC
Roundtable 1 Notes: AT Europe 2018
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What is the State of the Art Regarding Methods for Analysis of Glycans and Glycoproteins?
Roundtable 9 Notes: AT Europe 2019
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Process Analytical Technologies
Roundtable 7 Notes: AT Europe 2019
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Physio-chemical Methods to Replace Bioassays for Potency and Biological Activity Testing - Examples and Experience
Roundtable 8 Notes: AT Europe 2019
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New CE-based Methods in the QC Lab - What Are the Challenges and Learnings?
Roundtable 6 Notes: AT Europe 2019
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MS-based Methods in the QC Lab - What is the State of the Art?
Roundtable 5 Notes: AT Europe 2019
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Hot Topic – Unmet Needs on Analytical Characterization
Roundtable 10 Notes: AT Europe 2019
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HCP Testing Strategies
Roundtable 4 Notes: AT Europe 2019
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Development of Chromatographic Methods; The New and the Old
Roundtable 3 Notes: AT Europe 2019
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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