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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
November 01, 2009
How to Put QbD into Practice
From the Editor
What football and bioprocessing both have in common is that in both cases, success is a minimum requirement.
Manufacturing Economics Series
How to reduce plasmid-mediated metabolic burden for higher yields.
Perspectives on Outsourcing
An enterprise-wide quality management initiative is required to maintain supplier quality without sacrificing bottom-line objectives.
First in a three-part series that discusses the complexities of QbD implementation in biotech product development.
The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.
Conducting a FMEA analysis is a good first step in a risk-based approach for determining the need for a filter integrity test.
Heightened attention to product safety issues is slowing the approval process for new therapies.