Papers and Presentations
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- WCBP (49)
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From Benchtop to Approval in Record Time: A Case Study of Ronapreve Part 2
![System.Collections.Generic.List`1[System.String] Thumbnail](https://www.casss.org/images/default-source/cmc-japan/2021/cmcj2021_120x120_landingab7f5240-874a-41d5-9ba6-8b026ce25213.jpg?sfvrsn=31598406_1)
Speaker Presentation Willcockson Maren, Genentech, a Member of the Roche Group, 2021 -
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
![System.Collections.Generic.List`1[System.String] Thumbnail](https://www.casss.org/images/default-source/wcbp/wcbp2022_120x120_landing.jpg?sfvrsn=1c474dc1_1)
CMC Summary Paper: WCBP 2021 Special Edition -
In-depth Characterization of Cell Therapy Products Using Mass Spectrometry-based Proteomics
![System.Collections.Generic.List`1[System.String] Thumbnail](https://www.casss.org/images/default-source/regional-forums/rf2022_120x120_landing.jpg?sfvrsn=2b3291f3_1)
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
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Forced Degradation and MAM Workflows in Lead Optimization/Early Development
Speaker Presentation George Thompson, Alayna AbbVie Inc., 2021
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Application of MAM during Drug Development: Overcoming Technical Challenges While Advancing Product and Process Knowledge
Speaker Presentation Powers Thomas, Pfizer, Inc., 2021
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'Reliance' on Inspections: Not Just a Buzzword but a Real Opportunity
![System.Collections.Generic.List`1[System.String] Thumbnail](https://www.casss.org/images/default-source/cmc-latin-america/cmcl2022_120x120_landing.jpg?sfvrsn=af62427d_3)
Speaker Presentation Raviol Holger, F. Hoffmann La Roche Ltd., 2021 -
Accelerated Technology Transfer to Meet Demand for a Repurposed Biologic: Challenges, Successes and Lessons Learned
Speaker Presentation Raviol Holger, F. Hoffmann La Roche Ltd., 2021
CASSS On Demand
Access approved content from past meetings in the NEW CASSS On Demand platform. CASSS members have access to all available presentation recordings starting in April 2020. Visit https://ondemand.casss.org, login to your account, and select from the list of meetings to begin.