Biological Standardization

Abstract

The potency of a biological product usually needs to be assessed in terms of its biological activity rather than in terms of its chemical or physical properties. Biological variability means that this assessment depends on statistical techniques, such as bioassay and on the availability of biological standards, which have known properties. Standards can be local, as might be used within a company for the assessment of a new assay or international standards, which are required for the primary calibration of biological products.