Search results for "qbd" in Articles / App Notes
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Meeting the Process Development Challenges of a Diverse Biologic Pipeline
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In the current biopharmaceutical landscape, developers are constantly encountering new and diverse biological molecules with complex structures. While these novel biolog…
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Towards a Better Process Outcome
Considerations for improving outcome in biopharmaceutical process development.
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Introducing Process Characterization Kit: New Tools for Gaining Deeper Chromatography Process Understanding
Study the potential impact of resin ligand density on process outcome with Process Characterization Kits. The kits provide critical insights on resin variation within the ligand density specificatio…
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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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Five Control Strategy Options to Prevent Resin Variability Impact
Control strategies that assure product quality and process performance are essential in biomanufacturing. Here are the pros and cons of five control strategies that can provide process consist…
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Free On-Demand Webinar: Smart Process Development of Chromatography Steps
Smarter development of chromatography processes reduces timelines and improves outcomes.
Smart process development is a collection of approaches to improve and speed up process development—prov…
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Nurturing Knowledge from Disparate Data Streams
Leveraging vast quantities of analytical data requires digitalization and platform integration.
By Cynthia A. Challener
jijomathai/stock.Adobe.comAnalytical instrument…
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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…
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Utilization of Mechanistic Modeling to Improve Process Development
To follow the QbD paradigm and keep up with shorter timelines, process developers are evaluating different approaches to improve process development workflows and gain a better process understanding…
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Understanding Validation and Technical Transfer, Part 3
In terms of quality by design (QbD), specifications account for only one element of the overall product control strategy, which should employ a science and risk-based approach to define quality attrib…