Resources
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Unbiased Biotherapeutic Analysis: Achieved with Greater Efficiency and Higher Confidence in Results
Speaker Presentation Berger Warren Waters 2022
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Accumulus Synergy: Data Exchange within a Cloud-Based Ecosystem
Speaker Presentation Abernathy Michael Amgen 2022
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Using Prior Knowledge for Setting the Shelf Life of Biologics Products
Speaker Presentation Zimmerman Boris Genentech, a Member of the Roche Group 2022
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Lessons Learned: Compatibility
and In-Use Stability Studies
Speaker Presentation Swisher CDER FDA 2022
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Regulatory Perspective on Raw Material Challenges
Speaker Presentation Sadadiwala Miral Biomarin 2022
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High-Throughput Sequencing for Adventitious Virus Detection in Biologics
Speaker Presentation Khan Arifa CBER FDA 2022
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Overview of Predictive Modeling Methodologies for Stability and Shelf-Life Setting
Speaker Presentation Lennard Andrew Amgen 2022
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Microbial Challenge In-use Studies - Industry efforts to harmonize strategies in collaboration with Health Authorities
Speaker Presentation Leiske Seagen Inc. Zamiri Genentech 2022
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Use of Stability Modeling to Support Accelerated Biologicals and Vaccines Development and Real-Time Stability Supply
Speaker Presentation Clénet Didier Sanofi Pasteur 2022
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Regulator Review Preferences and Recent Review Trends - Questions, Key Issues - 2
Roundtable 40 Notes: WCBP 2022
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Method Selection and Acceptance Criteria to Support In-Use Stability and Compatibility Studies - 2
Roundtable 37 Notes: WCBP 2022
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mRNA - Vaccines and Beyond
Roundtable 34 Notes: WCBP 2022
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Acceleration and CMC - Novel Approaches to Enabling Acceleration
Roundtable 31 Notes: WCBP 2022
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Strategies for Setting Phase Appropriate Endotoxin Specifications
Roundtable 29 Notes: WCBP 2022
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New Advances and Applications in Real Time Release Testing
Roundtable 27 Notes: WCBP 2022
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Nitrosamine Risk Assessments – Implementation
Roundtable 26 Notes: WCBP 2022
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To Outsource (That Test) or Not to Outsource – That Is the Question! (Analytical Testing)
Roundtable 24 Notes: WCBP 2022
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Modernizing Stability ICH Guidance, Including Science and Risk-Based Approaches to Encompass Biologics and New Modalities
Roundtable 23 Notes: WCBP 2022
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Big Data Applications in Biopharmaceutical Process and Product Development
Roundtable 22 Notes: WCBP 2022
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Setting Specifications on Limited Data, Clinically Relevant Specs
Roundtable 21 Notes: WCBP 2022