Search results for " QbD"

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 |…

Article Handbook: Design of Experiments in Protein Production and Purification
Design of experiments (DoE) is a technique for planning experiments and analyzing the information obtained. The technique allows us to use a minimum number of experiments, in which we systematically v…

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling. By Elizabeth Rivera…

Article Mechanistic Modeling of Preparative Ion-Exchange Chromatography
The authors believe the industry will see a rise in modeling during the next decade as the biotech industry attempts to institutionalize the principles of QbD and PAT and moves towards continuous proc…

Article Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance. By Colin Jaques, Daniela Lega Over the past decade, two improved capabili…

Article Tackling Analytical Method Development for ADCs
Feb 01, 2015 By Cynthia Challener, PhD BioPharm International Volume 28, Issue 2 The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …

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