Quality by Design

Oct 15, 2018
BioPharm International
This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.
Oct 01, 2018
BioPharm International
Applied throughout a product’s lifecycle and across a company’s portfolio, quality risk management and knowledge management will enable more agile manufacturing and better quality standards in the future.
Sep 01, 2018
BioPharm International
The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.
Sep 01, 2018
BioPharm International
Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.
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
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