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Academic Connections and Collaborations to Accelerate Drug Development
Roundtable 14 Notes: WCBP 2022
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Global Filings, In-Country Testing Challenges and Solutions
Roundtable 12 Notes: WCBP 2022
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Comparability – Few Batches, Stability, Shelf Life
Roundtable 5 Notes: WCBP 2022
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Platform Approaches for Control Strategies in Submissions
Roundtable 1 Notes: WCBP 2022
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From Benchtop to Approval in Record Time: A Case Study of Ronapreve Part 2
Speaker Presentation Willcockson Maren, Genentech, a Member of the Roche Group, 2021
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Modernizing Regulations in the Context of COVID-19 in Canada
Speaker Presentation Turpin Jason, Health Canada, 2021
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From Benchtop to Approval in Record Time A Case Study of Ronapreve
Speaker Presentation Shameem Mohammed, Regeneron Pharmaceuticals, Inc., 2021
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ICH Q13 Update: Continuous Manufacturing of Drug Substances and Drug Products
Speaker Presentation Sakurai Kyoko, PMDA, 2021
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Regulating Vaccines During COVID-19
Speaker Presentation Overking Cassandra, CBER, FDA, 2021
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PMDA Perspective: Recent Trends in the
Regulation of Biopharmaceuticals
Speaker Presentation Naruse Ryoko, PMDA, 2021
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Regulatory Flexibilities in CMC Review on Vaccines under the COVID-19 Pandemic
Speaker Presentation Mitsuki Motoaki, PMDA, 2021
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COVID Vaccine Development Strategies, Challenges and Lessons Learned Regulatory CMC Perspective
Speaker Presentation Kavanaugh Nancy, AstraZeneca, 2021
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CMC Strategy Forum Japan 2021 Welcome and Introductory Comments
Speaker Presentation Arai Hiroyuki, PMDA, 2021
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Creating CMC Strategies for Pandemics and Beyond
CMC Summary Paper: WCBP 2021 Special Edition
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In-depth Characterization of Cell Therapy Products Using Mass Spectrometry-based Proteomics
Speaker Presentation Wang Lei, Takeda, 2021 -
Evaluation of Host Cell Proteins in Lenti Viral Vectors
Speaker Presentation Suravajhala Shilpa, bluebird bio, Inc., 2021
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The Integration of Mass Spectrometry to the Process Development of Fusion Protein Therapeutics
Speaker Presentation Shao Chun, Bristol-Myers Squibb Company, 2021
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Strategic Developing Process Analytical Technologies for Real Time Quality Attribute Analysis in Bioprocess Development
Speaker Presentation Ding Julia, Bristol-Myers Squibb Company, 2021
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Registration of Alternate Filters During Raw Material Shortages
Speaker Presentation Rhee Amy, Amgen Inc., 2021
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One Resin, Multiple Products: A Potential Solution for Supply Constraints
Speaker Presentation Mahajan Ekta, Genentech, a Member of the Roche Group, 2021