Papers and Presentations
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Polysorbate Degradation and Mitigation/Control Strategy Considerations
Speaker Presentation Wuchner Klaus, Cilag AG, and Yi Linda, Biogen, 2021
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Real Time Environmental Monitoring
Speaker Presentation Weber Jeffrey, Zoetis, 2021
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Quality Risk Management in the Manufacture of Advanced Therapy Medicinal Products
Speaker Presentation Walker Adam, GlaxoSmithKline plc, 2021
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Notified Body Experience with NBOps
Speaker Presentation Sutch Jonathan, BSI Group, 2021
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Identification of an Appropriate Similarity Condition
Speaker Presentation Schuster Manfred, AGES MEA, 2021
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A Critical Review of the Final EMA Reflection Paper on Statistical Methodology for the Comparative Assessment of Quality Attributes in Drug Development
Speaker Presentation Schiestl Martin, Sandoz GmbH, 2021
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Interfaces - Clinical Trials, Assays, and In-vitro-diagnostics
Speaker Presentation Reischl Ilona, AGES MEA, 2021
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Considerations on Multi-Attribute-Method (MAM) by LC-MS as QC Tool
Speaker Presentation Pohl Thomas, Novartis Pharma AG, 2021
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Successful Notified Body Opinion and Marketing Authorization Application, and an Approach to Life Cycle Management
Speaker Presentation Mingam Isabelle, UCB Farchim SA, 2021
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Revised EMA Reflection Paper: 'Similarity Condition' and 'Similarity Criterion' as Two Separate Aspects for the Comparison of Quality Attributes Data
Speaker Presentation Lang Thomas, AGES MEA, 2021
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Regulatory Considerations on mRNA Products in Cancer Therapy
Speaker Presentation Hoefnagel Marcel, MEB-Medical Evaluations Board, 2021
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Rapid Sterility Testing
Speaker Presentation Guest Miriam, AstraZeneca, 2021
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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 …
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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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Access approved content from past meetings in the NEW CASSS On Demand platform. CASSS members have access to all available presentation recordings starting in April 2020. Visit https://ondemand.casss.org, login to your account, and select from the list of meetings to begin.