BioPharm International, August 2010 - BioPharm International

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BioPharm International, August 2010
Features
Meningitis Vaccine Purification: Quality Control of Ultrafiltration Membrane Porosity
By Shwu-Maan Lee, PhD , Bob Kruse, PhD , Amy Robinson, PhD
How to balance porosity, plugging, and lot-to-lot variability in filters.
Technical and Economic Benefits of Membrane Chromatography During Polishing Steps
By Nathalie Frau, PhD , Janice Lim, PhD , Andrew Sinclair , Uwe Gottschalk, PhD
An analysis of flow rate, load density, viral clearance, and cost.
Development of a Novel Rolling-Tube Cell Culture Platform and Demonstration of System Feasibility
By Yuval Shimoni , Carmen Chin , Teng Liu , Veronica Hernandez-Rodriguez , Volker Moehrle , Peter Kramer , Jin Wang
Rolling-tube system balances scale-up accuracy and thoroughput.
USP <63> Mycoplasma Tests: A New Regulation for Mycoplasma Testing
By Raymond W. Nims, PhD , Elizabeth Meyers
What you need to know about USP chapter <63>.
Regulatory Beat
Manufacturing Compliance in the Spotlight
By Jill Wechsler
Plant closures, product recalls prompt FDA re-evaluation of GMP enforcement efforts.
Outsourcing Insights
Spanning the Globe
By Jim Miller
This month, we catch up on major developments around the world and their implications for the contract services industry.
Downstream Trends
Downstream Disposables: The Missing Link in the Disposables Chain
By Eric S. Langer
Although single-use systems are widely used in upstream unit operations, their acceptance in downstream processes has been slow.
From the Editor
Tug of War
By Laura Bush
Regulatory relief requires that regulators trust companies to know what they are doing, and to do it—consistently.
Disposables Advisor
Disposable Systems as a Platform Technology for R&D and Clinical Supply
By Andrew Sinclair , Miriam Monge
How a Big Pharma company tackled the move to disposable bioreactors.
Final Word
Myriad Decision Places Biotech at a Crossroads
By Michael A. Gollin , Rae Fischer
In light of the new ruling, patent licensees may want to re-evaluate the strength of their licensed patents.

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