Search results for "Quality-by-Design" in Articles / App Notes
Article
Application of Quality by Design to Viral Safety
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The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the quality of biopharmaceuticals. Using this approach, products are developed with a thorough under…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
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The quality-by-design principles that enable a manufacturer to limit and control the sources of process variability are equally important to measurement systems, because the variability in …
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles, which integrate quality control into the manufa…
Article
Preclinical Evaluation of Product Related Impurities and Variants
The data from these studies is together used to make overall risk assessment by assigning a severity score to each variant, in accordance with the principle laid down in quality-by-design (QbD) paradi…
Article
QbD Improves Cell-Culture Process Control
However, using a quality-by-design (QbD) approach that employs predictive modeling can improve the quality of end product as well as the efficiency of the bioprocess.
Real-time quality control
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Article
Continuous Manufacturing: A Changing Processing Paradigm
…ristic of continuous processing can facilitate real-time testing approaches and can support FDA’s quality-by-design (QbD) initiatives (4). Biotechnology products, when run continuously, can be sample…
Article
Quality by Design and Extractable and Leachable Testing
…r-intensive endeavor and resembles a “quality-by-QC test” strategy, rather than a more sensible quality-by-design (QbD) strategy that is expected today. If harmful leachables are found during stabili…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
…of its principles, Georges France, external relations head of quality at Novartis, noted at a joint quality-by-design workshop of EMA and Parenteral Drug Association (PDA) in London in late January 2…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
Article
Advancing QbD in the EU
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD) concepts over the past 10 years. In 2003, EMA set up a team to back activities in pro…