Resources
Home
/
Resources
-
A Probability-Based Modeling Approach for Characterization of ADC Charge Variants Separated by icIEF that Leverages Bottom-Up Mass Spectrometry Datasets
Speaker Presentation Waite Christopher, Seagen Inc., 2021 -
Use of Capillary Electrophoresis Methodologies to Guide mRNA CMC Development
Speaker Presentation Shepherd Samuel, AstraZeneca, 2021
-
Rapid Characterization of Charge Isoforms of New Modalities by iCIEF-MS
Speaker Presentation Lynch Patrick, CDER, FDA, 2021
-
Considerations for CMC Information to Support Emergency Use Authorization of Biotechnology Products
Speaker Presentation Lynch Patrick, CDER, FDA, 2021
-
Increasing CE-SDS Analysis Throughput From Sample Preparation to Data Analysis
Speaker Presentation Le Eleanor, Amgen Inc., 2021
-
Long Term Precision of Fast CZE of mAb and Fast CGE of Plasmids with Uncoated Capillary
Speaker Presentation He Yan, Pfizer, Inc. 2021
-
Accessing Precious Samples in Western Blots by Capillary Electrophoresis Interfaced to Membrane via Inkjet
Speaker Presentation Booth Peter-Philip, University of Michigan, 2021
-
Rapid Surface Cleanliness Verification Using Swab Sampling and Capillary Electrophoresis
Speaker Presentation Atia Mostafa, University of Tasmania, 2021
-
Polysorbate Degradation and Mitigation/Control Strategy Considerations
Speaker Presentation Wuchner Klaus, Cilag AG, and Yi Linda, Biogen, 2021
-
Real Time Environmental Monitoring
Speaker Presentation Weber Jeffrey, Zoetis, 2021
-
Quality Risk Management in the Manufacture of Advanced Therapy Medicinal Products
Speaker Presentation Walker Adam, GlaxoSmithKline plc, 2021
-
Notified Body Experience with NBOps
Speaker Presentation Sutch Jonathan, BSI Group, 2021
-
Identification of an Appropriate Similarity Condition
Speaker Presentation Schuster Manfred, AGES MEA, 2021
-
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
-
Interfaces - Clinical Trials, Assays, and In-vitro-diagnostics
Speaker Presentation Reischl Ilona, AGES MEA, 2021
-
Considerations on Multi-Attribute-Method (MAM) by LC-MS as QC Tool
Speaker Presentation Pohl Thomas, Novartis Pharma AG, 2021
-
Successful Notified Body Opinion and Marketing Authorization Application, and an Approach to Life Cycle Management
Speaker Presentation Mingam Isabelle, UCB Farchim SA, 2021
-
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
-
Regulatory Considerations on mRNA Products in Cancer Therapy
Speaker Presentation Hoefnagel Marcel, MEB-Medical Evaluations Board, 2021
-
Rapid Sterility Testing
Speaker Presentation Guest Miriam, AstraZeneca, 2021