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 ...

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 ...

Such testing is essential to ensure that the drug product maintains the desired efficacy and purity after transportation and storage. Various constituents of the pharmaceutical product, including the ...

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, ...

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 ...

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 ...

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 ...