BioPharm International, February 2010 - BioPharm International

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BioPharm International, February 2010
Features
Mathematical Programming for the Design and Analysis of a Biologics Facility
By Donald L. Miller , Derrick Schertz , Christopher Stevens , Joseph F. Pekny
How to improve facility design and predict capacity.
The Purification of Plasmid DNA for Clinical Trials Using Membrane Chromatography
By Miladys Limonta Fernández , Gabriel Márquez , Martha Pupo , Odalys Ruiz Hernández
Membrane chromatography ensures purity at high flow rates.
Statistical Equivalence Testing for Assessing Bench-Scale Cleanability
By Cylia Chen , Nitin Rathore , Wenchang Ji , Abe Germansderfer
The two-one-sided t-test compares the equivalency of two data sets.
Regulatory Beat
Biotech Manufacturing Under Scrutiny
By Jill Wechsler
Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics.
From the Editor
QbD Gains Momentum
By Laura Bush
One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.
Disposables Advisor
End-to-End Deployment of Single-Use Technology in Aseptic Filling of Vaccines at GSK
By Andrew Sinclair , Miriam Monge
How this Big Pharma company successfully implemented disposable technologies in its manufacturing plant.
Outsourcing Insights
Cautious Hopefullness: Contract Services Industry's Fortunes Unclear for 2010
By Jim Miller
As facility closures and layoffs continue, CRO and CMO executives are hoping for a better year, despite few positive signs.

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