Search results for " QbD" in Articles / App Notes
Article
Meeting the Process Development Challenges of a Diverse Biologic Pipeline
Click here to learn more >>
In the current biopharmaceutical landscape, developers are constantly encountering new and diverse biological molecules with complex structures. While these novel biolog…
Article
Towards a Better Process Outcome
Considerations for improving outcome in biopharmaceutical process development.
Learn more >
Article
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…
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
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…
Article
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…
Article
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…
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
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…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…