The introduction of biologicals into our drug armamentarium is complicating stability testing. For these complex molecules neither physicochemical data nor bioassays alone provide the complete picture ...

New and important techniques in stability testing are facilitating product development using the Quality by Design approach. Using these it is possible to develop products more quickly and reliably, ...

Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it. While every drug molecule is unique and brings its own ...

A series of practical exercises will take place throughout the programme to give participants the opportunity to apply their knowledge under the guidance of our experienced trainers.

MilliporeSigma, the U.S. and Canada life science business of Merck KGaA, Germany, says it has launched the first all-in-one, validated genetic stability assay of its kind. The Aptegra™ CHO genetic ...

Table 1. Factors to consider in real-time stability study (click to enlarge). Figure 1. Effect of material change on stability profile (click to enlarge). Figure 2. Correleation of stability failure ...