BioPharm International, June 2009 - BioPharm International

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BioPharm International, June 2009
Cover
Best Practices for Formulation and Manufacturing of Biotech Drug Products
By Satish K. Singh , Nitin Rathore , Arnold McAuley , Anurag S. Rathore, PhD
How to maintain product stability and prevent particulates.
Features
Using Fluorescence- Based Sensing to Accelerate Process Development
By Joe Qualitz
A prove-free system monitors accurately at very small scale.
Columns and Departments
The Ups and Downs of the FDA Budget
By Laura Bush
Importing foreign drugs is not the best way to increase access to medicine. The risks are too high, and it burdens the over-stretched FDA unfairly.
UK Service Providers Look to the New World
By Jim Miller
UK-based CMOs seek opportunities in new markets.
Stiffer Enforcement at the FDA
By Jill Wechsler
Agency officials promise swift action against violators of drug safety and quality regulations.
User Viewpoints on Disposables Implementation
By Andrew Sinclair , Miriam Monge
What end users think about single-use systems.
On the Horizon: New Expression Systems to Become Common Industry Platforms
By Eric S. Langer
New expression systems compete for attention.
Biological Potency Assays are Key to Assessing Product Consistency
By Tina S. Morris, PhD , Robert Singer , Michael R. Ambrose, PhD , Walter W. Hauck, PhD
Modern bioassays enable more accurate potency testing.

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