Search results for " quality" in Articles / App Notes
Article
Gene Therapies Push Viral Vector Production
Learning how process parameters in the upstream process influence the purification process is fundamental for a good quality-by-design strategy. Furthermore, it will be interesting to see the developm…
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Studying Resin Variability Using a Process Characterization Kit
Learn how Process Characterization Kits can be used to assess the potential impact of resin ligand density variability on product quality and process performance.
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Cell-Culture Advances Test Bioreactor Performance Models
To continue to drive efficiency and reduce cost of manufacturing while maintaining or improving quality, reducing bioreactor variation will be required, and predictive models can enable these variatio…
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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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Article
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…