Search results for "regulatory" in Articles / App Notes
Article
Ensure SEC Column Reproducibility in Protein Drug Analysis
Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you…
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
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Article
How Coupling MALS to IEX Can Help Protein Characterization
Coupling ion exchange chromatography (IEX) to multi-angle light scattering (MALS) can open new opportunities in protein characterization. Mario Lebendiker and Hadar Amartely from The Hebrew University…
Article
Prepare for an FDA Bioburden Inspection
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Not sure how to best approach a bioburden problem when an FDA inspection is imminent? Anastasia Lolas, former FDA Biologics License Application (BLA) revi…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
Article
State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
Since 2003, BioPlan Associates, Inc. of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity …
Article
Videos! SPR Applications in Protein Characterization
In these exclusive videos from the Biacore Analytical, Comparability and QC Symposium, Vienna, November 2017, industry thought-leaders share insights, tips, and techniques that illuminate how SPR with…
Article
Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This art…
Article
Process Economic Simulation for Scalable Production of Adenovirus
This application note discloses the process economic modelling of a modern start-to-finish adenovirus production process. The novel process was compared with a reference process in both stainless-st…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
Optimizing Late-Stage and Commercial Cell-Culture Processes
Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.
By Feliza Mirasol
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