Search results for "Quality-by-Design"

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
…ogy for developing a per product qualitative and semi-quantitative business case for application of quality-by-design (QbD) for a biopharmaceutical product. Previous authors have not frequently appro…

Article Application of Quality by Design to Viral Safety
40-47  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
48-64  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 …

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…

Article 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…

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