Search results for "analysis" in Articles / App Notes
Article
Tools for Continuous Bioprocessing Development
However, continuous culture operation, in all its forms--chemostat, turbidostat, and perfusion--can support metabolic flux analysis for increased process understanding (see sidebar). Continuous perfus…
Article
Biacore Concentration and Ligand-Binding Analyses
In this white
paper, the use of Biacore for active concentration measurements, target binding, and Fc receptor (FcR) analysis is reviewed along with the use of these assays for assessment of drug po…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Available risk scoring tools such as failure mode and effects analysis (FMEA) should be properly modified to allow suitable risk ranking of high-impact risks with respect to other less-impact risks du…
Article
Robust Optimization, Simulation, and Effective Design Space
Design of experiments (DOE) and other multivariate analysis techniques assist the developer in mapping out the design space and building process models. Once the DOE is complete, the developer can use…
Article
USP Publishes Monoclonal Antibody Guidelines
Because subclasses show differences in amino acid sequence and in the number of disulfide bonds, in some cases they require subclass-specific analysis. IgG-type monoclonal antibodies have a molecular …
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The result is a resolution map and optimized chromatogram within which the optimum conditions with respect to overall peak shape, resolution, and analysis time may be predicted (Figure 4).
…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
According to the case study, evaluation of statistical calculations, such as multivariate analysis, and the choice of experimental models on which QbD approaches are based, are challenging and require…
Article
Bioprocessing Advances in Vaccine Manufacture
According to BioPlan's recently released analysis of 10-year industry trends (1), a confluence of technological advances in bioprocessing is making vaccine manufacture cheaper, faster, and simpler. Th…
Article
Regulatory Challenges in the QbD Paradigm
…bility and product quality through appropriate control strategies, documentation, data trending and analysis, risk assessment, and continuous review. It is a living system that incorporates gained kn…
Article
QbD and PAT in Upstream and Downstream Processing
NMR could change the face of bioprocess development and monitoring because it provides access to component identity, plus quantitative data, rapidly and easily from a single analysis. NMR profiling ca…