Resources
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Overview of Genome Editing Products and
CMC Considerations
Speaker Presentation Ramsey Phillip Sangamo Therapeutics 2022
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Control of Allogeneic Donor Cells and Characterization: Integrating into Cell Therapy Regulatory Strategy
Speaker Presentation McCord Amy Takeda Pharmaceuticals 2022
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Product Development and Manufacturing of
oRNA™ Therapies
Speaker Presentation Maynor Benjamin Orna Therapeutics 2022
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FDA’s Efforts to Facilitate the Development of Cell and Gene Therapies
Speaker Presentation Marks Peter CBER FDA 2022
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Indian Canvas of Cell & Gene Therapy
Speaker Presentation Jotwani Geeta Indian Council of Medical Research 2022
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Cell Therapy Technology Transfer Approach and Challenges
Speaker Presentation Gelinas Peter ElevateBio 2022
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Capacity Planning Considerations for Autologous Cell Therapies
Speaker Presentation Collins Alicia Bristol-Myers Squibb Company 2022
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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