While stability testing for small molecule drugs is well established, its counterpart for biologicals is still evolving. Dozens of techniques have emerged for characterizing proteins, ranging from the ...

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, ...

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 ...

Stability studies are used to assess the shelf life of a product by storing samples under differing conditions, typically as defined by regulatory authorities, and then testing samples taken from ...

Selecting the right stability partner is crucial for accelerating your product’s journey to market while ensuring its safety and compliance. A partner with expertise in evolving regulatory ...