Quality by Design

Mar 01, 2018
BioPharm International
Modeling at various stages of the data analytics continuum aids scale comparison of a bioreactor.
Feb 01, 2018
BioPharm International
As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.
Dec 01, 2017
BioPharm International
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
Dec 01, 2017
BioPharm International
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
Oct 18, 2017
By BioPharm International Editors
The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.
Sep 01, 2017
BioPharm International Sponsored eBooks
By BioPharm International Editors
Apr 01, 2017
BioPharm International
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
Apr 06, 2015
BioPharm International
The authors review major developments in use of MVDA in bioprocessing applications.
Feb 01, 2015
BioPharm International
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Oct 01, 2014
BioPharm International
A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.
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