Search results for " analyses"
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
Biacore Concentration and Ligand-Binding Analyses
Biotherapeutic drugs including antibodies, cytokines, and hormones are used for treatment of a variety of diseases including arthritis, cancer, and diabetes. Compared to traditional small-molecule dru…
Article
Impurity Testing of Biologic Drug Products
…hy coupled to pulsed amperometric detection (HPAEC-PAD) methods for the quantitative and qualitative analyses of N- and O-glycosylation
• Liquid chromatography or electrophoresis method…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
More complex analyses, such as those required for protein and impurity identification and characterization, are conducted completely off-line. A sample is collected from the bioreactor and taken to a …
Article
Nurturing Knowledge from Disparate Data Streams
Spectra must be collected and separation analyses performed. The data obtained must be generated as a table, chart, or other picture that describes the results, which must then be compared to referenc…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
Therefore, in addition to structural and biochemical analyses of biosimilars for confirmation of the physical and chemical characteristics of the biosimilar, it is necessary to demonstrate that the ph…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
SPR applications are not only limited to ligand–receptor interaction kinetics dynamic analyses, but they are also used for drug discovery and development. There are several different formats …
Article
N-Glycan Analysis of Biotherapeutic Proteins
Recent developments in CE have allowed for rapid analysis, enabled by short run time on the Gly-Q (ProZyme) (43) or multiplexed analyses on the GlycanAssure (Thermo Fisher Scientific) (44) and GlyXera…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
This information, coupled with analyses following reduction and de-N-glycosylation, allows an initial assessment of the intactness of the product and a number of the post translational modifications p…