Search results for " analysis"
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
…p-wise method to build an ion-exchange mechanistic model using open-source chromatography design and analysis tool (CADET, https://github.com/modsim/CADET). The mechanistic model used in this approac…
Article
The Metrics of Quality Culture
…nel, the assumption being that the root cause of the original deviation (real or due to insufficient analysis) was determined to be insufficient or ineffectual training. The third proposed metric is …
Article
Best Practices in Qualification of Single-Use Systems
Key factors listed in the guidance document (7) include:
• “A supplier’s certificate of analysis can be used in place of performing other tests, provided that the manufacturer has a system in plac…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
Ligand-binding assays are of great importance for the analysis and comparison of the originator and biosimilar therapeutic for both testing of the drug before administration to preclinical or clinical…
Article
Application of Quality by Design to Viral Safety
Risk analysis and scientific characterization identify those components that will have the biggest effect on process consistency and CQA.
Identification of a multivariate design space in which dat…
Article
Raw Material Variability
Fixing Variability in Raw Materials
Current best practice to fix these compliance issues includes extensive investigation and characterization of the impact, multifaceted statistical analysis (m…
Article
Design of Experiments for Analytical Method Development and Validation
Quality risk management and statistical data analysis techniques should be used to examine the process of measurement and identify factors that may influence precision, accuracy, linearity, signal to …
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Topics covered include:
1:47 - Where the industry is headed with real-time analysis
3:17 - Scaling up
4:57 - Cell perfusion
7:16 - Criti…
Article
Using Digital Twins to Model Process Chromatography
A particularly powerful application of these tools to manufacturing, aside from predicting the influence of scale, is for root cause analysis; whilst a mechanistic model enables one to find optimal co…
Article
Understanding Protein Production from Start to Finish
Most scientists working with exploring proteins and developing specific target biomolecules use several steps including cell culture, sample preparation, purification, and analysis. This requires unde…