BioPharm International, April 2010 - BioPharm International

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BioPharm International, April 2010
Features
A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass Vials
By Xiaochun Yu, PhD , Don DeCou, PhD , Derek Wood , Steven Zdravkovic , Heather Schmidt , Laurie Stockmeier , Robert Piccoli, PhD , Daniel Rude , Xiaoya Ding, PhD
A systematic approach facilitates formulation component selection.
Developing a MAb Aggregate Removal Step by High Throughput Process Development
By Gustav Rodrigo , Kristina Nilsson-Välimaa
HTPD allows rapid screening of chromatographic parameters.
Applying Computational Fluid Dynamics Technology in Bioprocesses-Part 1
By Zhiwu (David) Fang
Computational fluid dynamics is a powerful tool to optimize processes.
Regulatory Beat
REMS Raise Concerns for Biotech Products
By Jill Wechsler
The FDA is expanding postmarketing safety requirements, despite limited resources to manage these added responsibilities.
From the Editor
Preparing For an Uncertain Future
By Laura Bush
Given today's challenges, traditional strategies were bound to change. Now, there is one more big threat (or opportunity?) on the horizon.
Final Word
Better Times Ahead for Biotech
By James C. Greenwood
This year's BIO International Convention will be occurring against a backdrop of profound change in our industry.
Burrill on Biotech
Biotech on a Roll to Start 2010
By G. Steven Burrill
As the capital markets in the US and globally continue to strengthen, the biotech industry can expect to see a rise in initial public offerings this year.
Outsourcing Insights
Complex Clinical Trials are Posing New Challenges Across the Clinical Supply Chain
By Jim Miller
The ability to deal with the complexity of the clinical supply process has shifted the balance of power to clinical supply chain specialists.

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