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, ...

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 ...

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 ...