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CMC Strategy Forum (31)

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CMC Strategy Forum North America Winter

Displaying results 1 - 20 of 41

CMC Strategy Forum North America 2023 Summary Infographic

Summary Infographic: CMC Strategy Forum North America 2023
Physicochemical In-use Studies: Industry Experts Insights

Speaker Presentation de Jong Genentech Liu Seagen 2022
Using Prior Knowledge for Setting the Shelf Life of Biologics Products

Speaker Presentation Zimmerman Boris Genentech, a Member of the Roche Group 2022
Lessons Learned: Compatibility and In-Use Stability Studies

Speaker Presentation Swisher CDER FDA 2022
Regulatory Perspective on Raw Material Challenges

Speaker Presentation Sadadiwala Miral Biomarin 2022
High-Throughput Sequencing for Adventitious Virus Detection in Biologics

Speaker Presentation Khan Arifa CBER FDA 2022
Overview of Predictive Modeling Methodologies for Stability and Shelf-Life Setting

Speaker Presentation Lennard Andrew Amgen 2022
Microbial Challenge In-use Studies - Industry efforts to harmonize strategies in collaboration with Health Authorities

Speaker Presentation Leiske Seagen Inc. Zamiri Genentech 2022
Use of Stability Modeling to Support Accelerated Biologicals and Vaccines Development and Real-Time Stability Supply

Speaker Presentation Clénet Didier Sanofi Pasteur 2022
Global Regulatory Requirements for Stability: It’s Not Such a Small World After All

Speaker Presentation St. Charles Amy, Pfizer Inc., 2020
Forced Degradation Studies in Support of Product Development and Registration

Speaker Presentation Krug Elisabeth, Eli Lilly and Company, 2020
Use and Interpretation of Accelerated Stability Studies

Speaker Presentation Krause Philip, CBER, FDA, 2020
A Regulatory Perspective on Stability Studies Supporting Comparability of Therapeutic Protein Products

Speaker Presentation Damdinsuren Bazarragchaa, CDER, FDA, 2020
The Predictive Value of Accelerated & Forced Degradation Data: A Case Study

Speaker Presentation Smith Dean, Health Canada, 2020
Demonstration of Comparability in Accelerated or Stressed Stability Studies Using Graphical and Statistical Methods

Speaker Presentation Burdick Richard, Burdick Statistical Consulting LLC., 2020
Providing the Right Data at the Right Time: Stability Strategies to Support Analytical Comparability

Speaker Presentation Rieder Noel, Amgen Inc., 2020
Control Strategies for Particles Arising from HCPmediated Degradation of Polysorbate: A Regulatory Perspective

Speaker Presentation Russell Paula, Health Canada, 2020
Polysorbate Degradation Case Studies: Characterization, Mechanism Elucidation, Mitigation Measures and Implications for Control Strategy

Speaker Presentation Koulov Atanas, Lonza AG, 2020
Excipients and Biotechnology Product Quality Attributes: a Regulator’s Perspective on Reducing the Interfacial Tension

Speaker Presentation Rao Ashutosh, CDER, FDA, 2020
New Aspects on the Degradation Mechanisms of Polysorbate: Complex Reaction Pathways of a Complex Surfactant

Speaker Presentation Schöneich Christian, University of Kansas, 2020

Displaying results 1 - 20 of 41

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