BioPharm International, July 2011 - BioPharm International

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BioPharm International, July 2011
Features
Biopharmaceutical Manufacturing Using Blow–Fill–Seal Technology
By Wei Liu , Philippe Lam , Scott Faulhaber , Samir Sane
The authors give special consideration factors affecting blow–fill–seal technology.
Fermentation Process Technology Transfer for Production of a Recombinant Vaccine Component
By Shamik Sharma , Allison Whalley , Joseph McLaughli , Frank Brello , Bruce Bishop , Amit Banerjee
The authors describe challenges faced in transfer and scale-up of a fermentation process.
From the Editor
Legislation v. Litigation
By Michelle Hoffman
Which route will we take to arrive at a national stem-cell policy?
Regulatory Beat
FDA and Manufacturers Ponder Biosimilars Pathway
By Jill Wechsler
Follow-on versions of complex biologics require extensive expertise.
Burrill on Biotech
Biotech Posts Strong Gains
By G. Steven Burrill
Strong pipelines, approvals, and deals drive up market cap.
Compliance Notes
Impact of cGMP on Supply Chain
By Carla Reed
Incorporating regulatory requirements into the product life cycle is crucial.
Perspectives on Outsourcing
Offsetting Budget Cuts
By Gregg Brandyberry
Better strategies and practices in sourcing and procurement can contribute to the bottom line.
Final Word
The Status of the DNA Vaccine Field
By Mark J. Newman
Plasmid DNA-encoding proteins offer many advantages, which are now being used in clinical trials.

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