ABSTRACT
The guidance stated in the International Conference on Harmonization harmonized tripartite guideline entitled “Stability Testing of New Drug Substances and Products” applies in general to biotechnological/biological products. The statistical methods that should be used are described in the tripartite guideline on stability. The use of different specifications for release and expiration should be supported by sufficient data to demonstrate that the clinical performance is affected, as discussed in the tripartite guideline on stability. The products are particularly sensitive to environmental factors such as temperature changes, oxidation, light, ionic content and shear. To ensure maintenance of biological activity and to avoid degradation, stringent conditions for their storage are usually necessary. The quality of the batches of drug substance placed into the stability program should be representative of the quality of the material used in preclinical and clinical studies and of the quality of the material to be made at manufacturing scale.
