Resources
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HDX-MS/Sample Prep
Roundtable 10 Notes: Higher Order Structure 2021
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COVID Therapeutics – How Are Analytical (HOS) Methods Being Used to Support Dramatically Shortened Development Timelines?
Roundtable 9 Notes: Higher Order Structure 2021
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Viral Delivery Therapeutics
Roundtable 8 Notes: Higher Order Structure 2021
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Best Practices in NMR Data Acquisition and Analysis
Roundtable 7 Notes: Higher Order Structure 2021
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Selected and Non-Aggregating Proteins - HOS in Candidate Selection and Optimization in Biologics Discovery Space
Roundtable 6 Notes: Higher Order Structure 2021
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Sub-visible Particle Characterization
Roundtable 4 Notes: Higher Order Structure 2021
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Analytical Ultracentrifugation
Roundtable 3 Notes: Higher Order Structure 2021
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Best Practice for Analyzing and Interpreting Routine Biophysical Assays (DLS, CD, DSC)
Roundtable 2 Notes: Higher Order Structure 2021
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Ervebo® vaccine for Ebola virus – a case study on approaches to accelerate process development and tech transfer
Speaker Presentation Califano Joseph, Merck & Co. Inc., 2021
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COVID Vaccines: Expediting Development While Ensuring Product Quality
Speaker Presentation Levis Robin, CBER, FDA, 2021
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CMC Considerations From Development Through Registration of An Autologous CAR-T Therapy
Speaker Presentation Gillet Delphine, Novartis Pharma AG, 2021
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Vector-based ATMP Development in the EU Regulatory and Scientific Considerations
Speaker Presentation Reischl Ilona, AGES MEA, 2021
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Regulatory Considerations for CAR T Cell Development
Speaker Presentation Schultz Kimberly, CBER, FDA, 2021
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Product and Process Characterization – The Data Sources for an Adequate Control Strategy
Speaker Presentation Gross Steffen, Paul-Ehrlich-Institut, 2021
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Justification of Specification & Life-cycle Management of Relevant Analytical Methods
Speaker Presentation Backofen Ulli, Boehringer Ingelheim, 2021
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Analytical Similarity Assessment for Biosimilar Initial Approval, Lifecycle Management, and Extrapolation of Indications
Speaker Presentation Liu Jennifer, Amgen Inc., 2021
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Comparability Exercise for Biologics: A Case Study
Speaker Presentation Chang Andrew, Novo Nordisk Inc., 2021
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Risk-based Comparability for Biological Products (Perspectives from a multi-national company)
Speaker Presentation Edwards Julia, Genentech, a Member of the Roche Group, 2021
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Application and Review: Trends in the Past Decade of Chinese Biopharmaceuticals
Speaker Presentation Wei Kaikun, Center for Drug Evaluation (CFDA), 2021
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The Criticality of Efficient CMC Changes Through the Product Lifecycle
Speaker Presentation Montgomery Frank, AstraZeneca, 2021