Biologies stability protocols

Potency studies should be performed at appropriate intervals as defined in the stability protocol, and the results should be reported in units of biological activity calibrated, whenever possible, against nationally or internationally recognized standards. Where no national or international reference standards exist, the assay results may be reported in in-house derived units using a characterized reference material. 

Stability Profile — Physical, chemical, biological, and microbiological behavior of a drug substance or drug product as a function of time when stored under the conditions of the Approved Stability Protocol. 

Testing of Biotechnological/Biological Products. Stability protocols should be... 

There is virtually no difference in the general requirements for a stability protocol for biologies from that required for a small molecule. Stability testing must be... 

According to the operational definition, it is most important that well-defined methods and clear protocols are provided describing the isolation procedure applied. After isolation, freeze-drying is often used to stabilize the final fraction and to prevent chemical and biological reactions during storage. Critical reviews on the isolation and concentration techniques for aquatic substances are given by Aiken (1985), Leenheer (1985), and Abbt-Braun and Frimmel (2002). 

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