Search results for " quality"

Article Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
So we do this by looking at the visual quality of fit, by looking at the confidence intervals of these fitted parameters, and of course propagating them through to any model predictions. And finally, …

Webcast A route to deeper process understanding-Studying resin variability using a Process Characterization
Chromatography resin attributes can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand. Ligand density is an important…

Article FDA Provides Guidance on Bispecific Antibody Development Programs
FDA published final guidance on May 24, 2021 to provide industry and stakeholders with recommendations for the development of bispecific antibodies including recommendations for regulatory, quality, n…

Article Traceability in Western Blot Imaging: Considerations for GxP
LEARN MORE >> Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both tra…

Article Cytiva Advances Fiber Chromatography Technology with New Launch
The product quality is comparable to resin purification and the eluate is more concentrated. This is a great technology that allows rapid [P]rotein A purification and saves precious time, while mainta…

Article Controlling Cell Culture Process Variability Through Supplier-Enabled Data Management and Analytics
Variability can be reduced across the biopharmaceutical value chain by characterizing raw materials, monitoring materials quality, and controlling raw material usage. Click here to learn more >…

Article Biomanufacturing: Demand for Continuous Bioprocessing Increasing
- Improved quality: Biological molecules are expressed continuously, and compared to batch culture, continuous culture tends to be more controllable, less intense and stressful, including less shear a…

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…

Article 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. Click here to read mor…

Article 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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