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October 02, 2019
In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.
September 15, 2019
Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
September 02, 2019
At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.
As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.
August 15, 2019
GNA Biosolutions has completed its latest round of Series C financing in which it raised US$13.5 million.
August 12, 2019
The Tridex Protein Analyzer from IDEX offers the ability to directly measure protein titer from a bioreactor in real time.
August 02, 2019
A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.
To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.
The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.
Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.