Search results for "Quality-by-Design" in Articles / App Notes
Article
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…
Article
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 …
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…