What are biological reference materials?

Biological medicines are more complex than chemically synthesised drugs and therefore cannot be characterized and measured using standard physiochemical means alone.  Instead bioassays are performed which require the use of a biological reference material to ensure standardisation of the results.

WHO biological reference materials (WHO International Standards and other materials) provide a common set of standards which are used to ensure the quality of biological medicines world wide.  These International Standards are considered to be the ‘gold standard’ against which regional, national and international laboratories and manufacturers calibrate their own working standards.  They are calibrated in units of biological activity which are assigned following extensive studies involving multiple international laboratories.

Biological Reference Materials Catalogue.