What are biological reference
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