Search results for " reproducibility" in Articles / App Notes
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Excluding scientific misconduct, which is not a major source of irreproducibility (5), lack of reproducibility typically results from cumulative errors or flaws in one or more of the following, non-di…
Article
Ensure SEC Column Reproducibility in Protein Drug Analysis
This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.
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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
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
Single-Use Technologies Prove Effective for Viral Vector Process Development
“Scaling-out to achieve large quantities of viral vectors presents several drawbacks that lead to footprint, capital, and operational expense, and reproducibility issues. Developers are consequently t…
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
Particular care must be taken to ensure cells are present as single units in order to promote even cell distribution throughout the bed, which is a paramount to ensure process predictability and repro…
Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
Article
Virus-like Particles as Therapeutic Moieties of the Future
These biophysical, biochemical, and immunochemical methods ensure process reproducibility and product consistency in recombinant VLPs during the manufacturing process. These characterization methods a…
Article
Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity.
By…
Article
Scaling Up Novel Therapies
Scaling Up Novel Therapies
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
By Agnes S…