Stability Testing of Biotechnology Drug Products

The evaluation of stability may necessitate complex analytical methodologies. Assays for biological activity, where applicable, should be part of the pivotal stability studies. Appropriate physicochemical, biochemical, and immunochemical methods for the analysis of the molecular entity and the quantitative detection of degradation products should also be part of the stability program whenever purity and molecular characteristics of the product permit use of these methodologies. 

With these concerns in mind, the applicant should develop the proper supporting stability data for a biotechnological or biological product and consider many 

For the basic terms used in this section, the reader is referred to the Glossary. However, because manufacturers of biotechnological and biological products sometimes use traditional terminology, traditional terms are specified in parentheses to assist the reader. 

Handbook of Pharmaceutical Manufacturing Formulations Semisolid Products 

Where pilot-plant scale batches were submitted to establish the dating for a product, and in the event that the product produced at manufacturing scale does not meet those long-term stability specifications throughout the dating period or is not representative of the material used in preclinical and clinical studies, the applicant should notify the appropriate FDA reviewing office to determine a suitable course of action. 

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