Before any formulation work is developed, it is necessary to determine the nature of the biologic API. The purity profile must be established and specifications must be set for the allowable levels of impurities. The change of impurities with storage time must be established by subjecting the biologic API to various accelerated and stress storage conditions to find the optimal conditions which minimize formation of degradants. These early stability studies may determine that the biologic API should be stored under non-ambient conditions such as low temperature, low humidity, non-oxidizing and low-light environments.
Stability studies of biologic API will also provide data to establish a retest time for the raw materials used in the process. Stability indicating methods must be developed to monitor the purity of the biologic API as well as identification and quantitation of impurities. If impurities are shown to be process related, then they may be monitored at release but do not need to be monitored during long-term stability. However, if any of these impurities are shown to increase during storage, or if new impurities are developed, these are referred to as degradation products and analytical methods must be developed to monitor these degradants during stability studies.
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