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January 02, 2014
Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
June 14, 2013
PSL has developed a microsphere refiner for microsphere formulation, from small scale processes to commercial production.
September 01, 2012
There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.
April 02, 2012
In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.
How to use geographic diversification and legacy technology transfers to avoid product shortages.
February 02, 2012
A nickel's worth of free advice to the competition could come at the expense of your bottom line.
Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material.
January 02, 2012
Technology may expedite operations, but the absence of the human element could cost dearly.
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.