Resources
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Extractable and Leachable Studies: Best Practices, Case Studies, and Regulatory Update
Roundtable 7 Notes: WCBP 2021
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Manufacturing, Characterization and Testing for Bispecific Antibody
Roundtable 6 Notes: WCBP 2021
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Trace Metals - Challenges and Controls in Raw Materials and Fermentation Media
Roundtable 5 Notes: WCBP 2021
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Host Cell Proteins – Identification, Strategies, Successes and Challenges
Roundtable 3 Notes: WCBP 2021
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Cell and Gene Therapy Products - Manufacturing Control Strategy and CQAs
Roundtable 2 Notes: WCBP 2021
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Linking CQAs, ClinicalOutcomes, and Attribute-based Specs for Fast to Approval Therapies
Roundtable 1 Notes: WCBP 2021
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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