Resources
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Quality by Design for Biotechnology Products: An FDA Perspective
Speaker Presentation Graham Laurie CDER FDA 2022
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SLIM Based High-Resolution Ion Mobility for Large Biomolecule Characterization
Speaker Presentation Doherty Tom MOBILion Systems Inc 2022
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N-GLYcanyzer: PAT Toolkit for Near
Real-Time Monitoring of Monoclonal Antibody (mAb) N-Glycosylation
Speaker Presentation Chundawat Shishir Agilent Technologies 2022
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Regulatory Approaches to Accelerated Development of SARS-CoV Neutralizing Antibodies and Vaccines
Speaker Presentation Cho Gutierrez Lugo CBER CDER FDA 2022
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Protein Nanoparticle Vaccines –
A Platform Enabling Rapid Translation from Design to Clinic
Speaker Presentation Carter Lauren University of Washington 2022
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Recombinant Factor C: An Approved and Sustainable Bacterial Endotoxins Test
Speaker Presentation Bolden Jay Eli Lilly and Company 2022
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From Anton to Omicron and Beyond: Towards an mRNA Vaccines Platform
Speaker Presentation Blaschke Ulrich BioNTech 2022
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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