BioPharm International
July 01, 2015
Features
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The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
July 01, 2015
Features
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The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.
July 01, 2015
Features
28
7
Advances in adventitious agent detection methodology are bringing benefits, but more work needs to be done.
July 01, 2015
Features
28
7
When using media supplements in biologics, it is important to have a key understanding of both the supplement and the base medium to ensure high titer and stability.
July 01, 2015
Peer-Reviewed Research
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Low endotoxin recovery represents an opportunity to add value to the characterization of biologic drug products.
July 01, 2015
European Beat
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The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.
July 01, 2015
From the Editor
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As biopharma enjoys success, it cannot ignore pressing patient access questions.
July 01, 2015
Perspectives on Outsourcing
28
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While all market signs are pointing up, memories of past setbacks may discourage CDMOs from expanding capacity.
July 01, 2015
Regulatory Beat
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Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
July 01, 2015
Analytical Best Practices
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Approaches to the generation of process models, optimization techniques, and application of a design space are explored.
July 01, 2015
Product Spotlight
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GEA’s Panther NS3006L high-pressure homogenizer is a standalone unit designed to reduce particle size to nanometer ranges.
July 01, 2015
Product Spotlight
28
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Sartorius Stedim Biotech’s Sartoclear Dynamics is a clarification system designed to harvest mammalian cell cultures with high cell densities using single-use technology.
July 01, 2015
Issue PDF
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