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September 21, 2011
In a 2004 guidance, FDA says that the "use of redundant sterilizing filters should be considered in many cases." But not all manufacturers agree on what redundant filtration is.
September 01, 2011
Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.
Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.
Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.
August 11, 2011
Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.
August 02, 2011
A path to personalized medicines creates a new paradigm for development and manufacturing.
July 02, 2011
The performance of biotechnology venture capital and investment is lackluster at best.
June 02, 2011
More sophisticated biological expression systems expand the functionality of the traditional systems for protein synthesis.
Academic–industry partnerships are increasingly important in biopharmaceutical innovation.
April 02, 2011
An uncertain regulatory environment affects funding for biotechnology.