Search results for "analysis"
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
A subset from this screen was selected for analysis with the 2-over-2 kinetics approach. This method provides rapid screening in combination with data-rich selection of fragments with high affinity an…
Article
Vaccine Development Faces Urgency and Challenges
The campaign has helped move more vaccine candidates through clinical testing to market approval, according to an analysis in the February 2016 special issue on vaccines in the journal Health Affairs …
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).
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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…