OR WAIT null SECS
October 02, 2012
This study examines the effect and interaction of variations in hypromellose physicochemical properties.
August 02, 2012
Meticulous system configuration can prevent machines from taking over.
August 01, 2012
The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.
July 02, 2012
Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.
May 02, 2012
A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments.
Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.
November 10, 2011
On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.
November 01, 2011
June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.
September 02, 2011
Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.
September 01, 2011
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.