Resources
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Welcome & Introduction to EFPIA MQEG Biomanufacturing Satellite Session
Speaker Presentation Goese Markus, F. Hoffmann-La Roche Ltd, 2021
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ICH Q9 Risk Management Practical Applications for ATMPs - An AAV Case Study
Speaker Presentation Cowgill Cynthina, BioMarin Pharmaceutical, Inc., 2021
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Monitoring Clearance of Lipase Host Cell Proteins in mAb Manufacturing Using an LC-MS/MS Quantitation Method
Speaker Presentation Chen Rachel, Biogen, 2021
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A Risk-Based Approach to the Determination of the Control System for an AAV-based Gene Therapy Product
Speaker Presentation Challand Andrea, F. Hoffmann-La Roche Ltd, 2021
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Notified Bodies and Their Roles in Assessing Quality of Drug Delivery Devices
Speaker Presentation Caro-Barri Julia Slides, Notified Body No. 0318, based at the Spanish Medicines Agency (AEMPS), 2021
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Challenges of Formulation of mRNA Products
Speaker Presentation Borchard Gerrit, University of Geneva, 2021
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Agile (aka Autonomous & Portable) Manufacturing with Specific Focus on Aseptic Modular Chamber
Speaker Presentation Bechtold-Peters Karoline, Novartis Pharma AG, 2021
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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