When should a forced degradation testing be initiated and how should the approach to design be? Are there any case studies for CAR flow assays, ELISA based assays? Can linearity study be leveraged somehow to generate forced degradation assessment?
I have no experience with CAR and ELISA assay forced degradation. Available guidance, such as the Brazilian ANVISA, Guideline No. 04/2015 focus on chemical actives, so the degradation conditions should be adjusted to the intrinsic stability of the object. However, keep in mind that the primary intention of forced degradation is to elucidate the degradation pathway and to define cautions for analytical and handling conditions (e.g. to avoid shaking, light, temperatures). Also, the degradation should be limited to 10-15% to avoid irrelevant degradation products. My preference for validation is the use of accelerated condition samples to show stability indication.
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