Search results for "Quality-by-Design"
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
They debated the relevance of quality standards set by the International Council for Harmonization (ICH) and how well quality-by-design concepts can help understand and manage change. There were many …
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Speed and Flexibility Are Dual Goals for Biopharma Operations
The use of modeling to develop bioprocessing operations and systems—spurred by quality-by-design efforts—can help biopharma companies to better understand processes and equipment and to optimize manuf…
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Biosimilars to Drive Modern Manufacturing Approaches
These activities can help refine the manufacturing process, where incorporation of advanced techniques and quality-by-design approaches may facilitate “fingerprint”-like analysis of a biosimilar seeki…
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Efforts Accelerate to Streamline Postapproval Change Process
FDA and other regulators have sought to address these issues by encouraging industry adoption of continual improvement and quality-by-design approaches, along with change management protocols and life…
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Continuous Processing for the Production of Biopharmaceuticals
The implementation of process analytical technologies and quality-by-design approaches are bound to play a vital role in its success.
As is true for any new technology, adaptation for continuous b…
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Going Small to Achieve Success on the Commercial Scale
The impact of QbD and DoE
The quality-by-design (QbD) approach to process development requires characterization of the impacts of different process parameters on product critical quality attribute…
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
In addition to assessing factors and conditions for the optimization of the purification steps, the quality-by-design (QbD) initiative introduced by FDA requires a deeper understanding of critical pro…
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Quality Systems Key to Lifecycle Drug Management
FDA officials have long proposed that manufacturers implementing quality-by-design (QbD) approaches and quality controls should be able to manage postapproval changes with less regulatory oversight. T…
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A Bright Future for the Plasma Fractionation Industry
Among the quality and regulatory trends, Quality-by-Design (QbD) remains to be a popular topic. Philippe Paoloantonnacci presented a QbD approach for a new LFB IVIg product, with identification of Pro…
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Tackling Analytical Method Development for ADCs
He also notes that with the move to adopt a quality-by-design (QbD) approach for defining critical quality attributes for ADC, it is becoming easier to demonstrate the reproducibility of conjugation a…