Search results for "Quality-by-Design"
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Mechanistic vs Statistical Models
Mathematical models are recommended by the ICH Q8 guidelines on pharmaceutical development to generate enhanced process understanding and meet Quality-by-Design (QbD) guidelines. Read on the d…
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Maximum Output Starts with Optimized Upstream Processing
Similarly, accurate scale-down models and the use of a quality-by-design approach during development are minimizing risk and providing increased predictability when moving to large-scale production
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Using Digital Twins to Model Process Chromatography
…ecuring itself the standard approach for improved process performance, intensified development, and quality-by-design compliance.
Additionally, mechanistic modeling has an ever-growing research a…
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Selecting Chromatography Formats for Your Process Development Workflow
The quality-by-design initiative by the FDA puts additional demands on process development work because a higher degree of process understanding is needed.
Therefore, the choice of tools is critic…
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Gene Therapies Push Viral Vector Production
Learning how process parameters in the upstream process influence the purification process is fundamental for a good quality-by-design strategy. Furthermore, it will be interesting to see the developm…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
FDA’s quality-by-design (QbD) and validation initiatives also encourage the use of modeling early on.
While QbD does not define manufacturing design space or specific protocols, it does discuss…
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Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it challenging to apply quality-by-design (QbD) methods and process analytic…
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Nurturing Knowledge from Disparate Data Streams
One example relates to the move to a quality-by-design approach to process development. With this approach comes a geometric expansion in the quantity of data being acquired to characterize a process.…
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Advances in Engineering of Protein-Based APIs
New strategies are also being applied to the development of engineered proteins that integrate developability prediction, manufacturability assessment, and quality-by-design early in the process. “Thi…