Resources
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Building a Cell Therapy Supply Chain: Leveraging Digital Solutions to Manage Complexity, Reduce Risks, and Set Up For Commercialization
Speaker Presentation Chiu Kawa Lyell 2022
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Supply Chain Challenges of Fully Individualized Therapies
Speaker Presentation Case James Andrew Genentech, a Member of the Roche Group 2022
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Improved Strategies for Enhanced Protein Characterization of Highly Glycosylated Molecules
Speaker Presentation Widdowson Philip Genovis 2022
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Glycosylation Analysis of Recombinant and Vaccine-derived SARS-CoV-2 Spike Glycoproteins
Speaker Presentation Watanabe Yasunori AstraZeneca 2022
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A Perspective on the Contribution of Spectroscopy to Characterising Proteins for Quality Control
Speaker Presentation Rodger Alison Macquarie University 2022
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The Fine Art of Destruction for In-Depth Mass Spectrometry-Based Glycoproteomics: Advances in Measurement and Data Analysis — Exploiting the Diagnostic Potential of Fragment Ions
Speaker Presentation Rapp Erdmann Max Planck Institute for Dynamics of Complex Technical Systems 2022
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Considerations for the Application of Multi-Attribute-Method (MAM) by Mass Spectrometry for QC Release and Stability Testing of Biopharmaceuticals
Speaker Presentation Pohl Thomas Novartis 2022
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Accelerating Global Supply of Vaccines –Lessons Learnt
Speaker Presentation Pellet Mark AstraZeneca 2022
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Regulatory Experience from the Rolling Review Process and the Conditional Marketing Authorisation Process for COVID-19 Vaccines
Speaker Presentation Pedone Elisa European Medicines Agency 2022
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The Case for Revision to the ICH Stability Guidelines: An Industry Perspective
Speaker Presentation Lennard Andrew Amgen Inc. 2022
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Transmission Electron Microscopy - Utilising a Powerful Tool in Biosafety as a Novel Approach
Speaker Presentation Layland Ashely neotem Bioanalytics 2022
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The Future is Now: ICH Q14: Analytical Procedure Development ICH Q2(R2): Validation of Analytical Procedures
Speaker Presentation Keire David CDER, FDA 2022
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Strategies of Overcoming Risks of Changing Analytical Methods
Speaker Presentation Gellermann Gerald Novartis 2022
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Capillary Electrophoresis and Taylor Dispersion Analysis for the Characterization of mRNA Vaccines
Speaker Presentation Cottet Hervé IBMM, Université de Montpellier 2022
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Development of New Ph. Eur. “Horizontal Standards” for Monoclonal Antibody Analysis: An Overview from the EDQM
Speaker Presentation Buda Mihaela EDQM 2022
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Cutting-Edge Multi-Level Analytical and Structural Characterization of Antibody-Based Therapeutics
Speaker Presentation Beck Alain Pierre Fabre Group 2022
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Biological Reference Standards for Multivalent Vaccines - Qualification, Strategies and Challenges From a National Control Lab Perspective
Speaker Presentation Tesolin Lorenzo Sciensano 2020
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Double Duty Bioassays: A Regulatory
Perspective on Bispecific Antibody
Bioassay Development
Speaker Presentation Nickens Kristen US FDA 2020
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Development and Qualification of a Potency Assay to Support Gene Therapy
Speaker Presentation Maheno Hannah Sanofi 2020
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Flow into the Future - The Importance of Flow Cytometry Methods in Engineered T Cell Therapies
Speaker Presentation Lowe Emily Kite 2020