To fully characterise biological products, it is necessary to define the degradation pathways by which they can be converted into other forms. However, if determined in real-time with stability studies, this process could take several years.
At RSSL, we apply forced degradation conditions - temperature, pH, redox, light, humidity and shear stress - to accelerate this process. This enables the production of enough drug degradation products (5-20%) to be useful in stability indicating method development and validation.
In addition to conducting the studies, our technical experts can also build a robust regulatory compliant data package to support your regulatory submission.
Forced degradation studies are used to:
To identify the optimal conditions, each drug will require a tailored forced degradation protocol. This optimisation is performed using a robust feasibility study resulting in the development of a bespoke method capable of achieving suitable drug degradation levels.