Search results for " quality"
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Four Steps Toward End-to-End Connected Manufacturing
Continuous biomanufacturing is a key step toward promoting drug quality and improving manufacturing productivity, leading to lower drug prices.
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Getting it Right from the Start in the Drug Development Process
Both upstream processing and downstream processing can affect critical quality attributes of the drug molecule under development. These effects can result in process-related impurities, product impuri…
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Webinar On Demand: Expanding SPR Uses in Antibody Effector Function Determination
Register now to view the presentation on-demand and download a free copy of our poster booklet: Better biotherapeutic characterization for improved quality control.
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Chi2 and residual values were used to evaluate the quality of fit between the experimental data and individual binding models. Plots of residuals indicate the difference between the experimental and r…
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Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
This article focuses on concentration assays used for drug product characterization and quality control.
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Scalable Viral Vector Manufacturing
Also, the cell culture medium and any supplements need to be of clinical grade quality. From a regulatory perspective, it is recommended to avoid any raw materials that are of animal origin such as se…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
…in biopharmaceuticals due to the lack of intellectual property protection and the virtual absence of quality management systems. Today, many Chinese companies are expanding through biosimilars, contr…
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Automation Trend in Fill/Finish Reduces Contamination Risk
…atively slow, which has resulted in only incremental improvements in safety, efficiency, and product quality. The rise of costly biologics over the past 20 years, however, has put greater pressure on…
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Get Acquainted with How SPR Technology is Used for Better Protein Characterization
Stay up-to-date with our new e-book on the latest in SPR technology and use in the fields of process development and product quality control.
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Modern Manufacturing Key to More Effective Vaccines
Similarly, Cristiana Campa of GSK Vaccines in Italy emphasized that the complexity of vaccine development makes it important to define a control strategy for identifying critical quality attributes as…