BioPharm International
November 01, 2009
Issue PDF
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How to Put QbD into Practice
November 01, 2009
From the Editor
22
11
What football and bioprocessing both have in common is that in both cases, success is a minimum requirement.
November 01, 2009
Manufacturing Economics Series
22
11
How to reduce plasmid-mediated metabolic burden for higher yields.
November 01, 2009
Perspectives on Outsourcing
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11
An enterprise-wide quality management initiative is required to maintain supplier quality without sacrificing bottom-line objectives.
November 01, 2009
Cover
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First in a three-part series that discusses the complexities of QbD implementation in biotech product development.
November 01, 2009
Compliance Notes
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11
The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.
November 01, 2009
Features
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11
Conducting a FMEA analysis is a good first step in a risk-based approach for determining the need for a filter integrity test.
November 01, 2009
Regulatory Beat
22
11
Heightened attention to product safety issues is slowing the approval process for new therapies.