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 ...

Dynamic Multimode Spectroscopy Found Niche for Monitoring Changes in Secondary Structure In recent years, antibodies and recombinant proteins have become well-established pharmaceutical therapeutics ...

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 ...

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 ...

Thermal stability is a critical quality attribute that is crucial to monitor during the development of therapeutic proteins to ensure their structural integrity and efficacy during manufacturing, ...

Stability studies are a cornerstone of pharmaceutical quality. They ensure that a pharmaceutical product will maintain its efficacy and safety for its established shelf life to protect patient safety.