Resources
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Application of Quality Risk Management to an Oncolytic Virus, IMLYGIC® (talimogene aherparepvec)
Speaker Presentation Anderson Brian, Amgen Inc., 2021
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Troubleshooting Report - CZE and CE-SDS the Discussion Continues
CZE and CE-SDS the Discussion Continues -
Troubleshooting Report - cIEF and materials for CZE
cIEF and materials for CZE
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Troubleshooting Report - Ghostly Peaks and other Haunting Aberrations in CE
Ghostly Peaks and other Haunting Aberrations in CE
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Troubleshooting Report - CE-SDS: baseline disturbances, peak area repeatability and the presence of ghost peaks
Troubleshooting CE-SDS: baseline disturbances, peak area repeatability and the presence of ghost peaks
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Stability Considerations and Challenges in Autologous Cell Therapy
Speaker Presentation Polson Nolan, Bristol-Myers Squibb Company, 2020
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Global Regulatory Requirements for Stability: It’s Not Such a Small World After All
Speaker Presentation St. Charles Amy, Pfizer Inc., 2020
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Forced Degradation Studies in Support of Product Development and Registration
Speaker Presentation Krug Elisabeth, Eli Lilly and Company, 2020
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Use and Interpretation of Accelerated Stability Studies
Speaker Presentation Krause Philip, CBER, FDA, 2020
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A Regulatory Perspective on Stability Studies Supporting Comparability of Therapeutic Protein Products
Speaker Presentation Damdinsuren Bazarragchaa, CDER, FDA, 2020
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The Predictive Value of Accelerated & Forced Degradation Data: A Case Study
Speaker Presentation Smith Dean, Health Canada, 2020
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Demonstration of Comparability in Accelerated or Stressed Stability Studies Using Graphical and Statistical Methods
Speaker Presentation Burdick Richard, Burdick Statistical Consulting LLC., 2020
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Providing the Right Data at the Right Time: Stability Strategies to Support Analytical Comparability
Speaker Presentation Rieder Noel, Amgen Inc., 2020
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Control Strategies for Particles Arising from HCPmediated Degradation of Polysorbate: A Regulatory Perspective
Speaker Presentation Russell Paula, Health Canada, 2020
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Polysorbate Degradation Case Studies: Characterization, Mechanism Elucidation, Mitigation Measures and Implications for Control Strategy
Speaker Presentation Koulov Atanas, Lonza AG, 2020
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Excipients and Biotechnology Product Quality Attributes: a Regulator’s Perspective on Reducing the Interfacial Tension
Speaker Presentation Rao Ashutosh, CDER, FDA, 2020
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New Aspects on the Degradation Mechanisms of Polysorbate: Complex Reaction Pathways of a Complex Surfactant
Speaker Presentation Schöneich Christian, University of Kansas, 2020
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Mechanisms of Surfactant Degradation: Focus on Enzymatic Hydrolysis
Speaker Presentation Huang Lihua, Eli Lilly and Company, 2020
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A Multi-company Assessment of Submicron Particle Levels in Biotechnology-derived Protein Products
Speaker Presentation Hubert Mario, Bristol-Myers Squibb Company, 2020
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Visible Particles from Polysorbate Degradation
Speaker Presentation Nikels Felix, Boehringer Ingelheim Pharma GmbH & Co. KG, 2020