The history of biological standardisation dates back well over 100 years and comes from medical interventions such as the use of horse anti-diphtheria sera for passive immunisation, and the use of pancreatic extracts (insulin) to treat diabetes mellitus.
The pioneers in the field of standardisation, Paul Ehrlich and Henry Dale respectively, realised that the potencies of the products differed between batches, and that for effective therapy there would have to be effective control of the potencies.
With a lack of any meaningful information as to the physical nature of the active entities in these medicines, the problem was solved by treating them as quantifiable activities, setting up biological test systems, and referencing the measured activities against the activities of ‘standard’ batches of the product.
The science of biological standardisation is in fact three separate disciplines:
The fundamental principles of biological standardisation remain in place to the present day. Complex macromolecules of biological origin are generally considered to depend on some kind of bioassay as part of their characterisation, and, in partnership with the World Health Organisation, NIBSC is the world’s principal provider of reference standards to support these tests.
From its earliest beginnings in the fields of hormones and antisera, the program has grown to include:
chromatographic, electrophoretic and spectroscopic physico-chemical methods