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Medicines & Healthcare products Regulatory Agency
The National Institute for Biological Standards and Control

Confidence in biological medicines

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  • History of standardisation

The history of standardisation

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 development  and use of quantitative biological methods (bioassays)
  • the development of a separate branch of biostatistics to analyse data from such test methods
  • the ability to physically prepare stable and reproducible batches of standard medicines

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:

  •          standards for therapeutic products of human blood (eg clotting factors)
  •          standards for therapeutic products derived from biotechnology (cytokines, growth factors, hormones, clot-lysis enzymes)
  •          standards for therapeutic products derived from other natural sources (cells, tissues, urine etc)
  •          standards for viral and bacterial vaccines
  •          standards to support diagnostic measurements in the fields of transmissible diseases, physiology and genetics.
  •          standards to support a range of test methodologies extended  far beyond  the original bioassays to include:
    • immunoassays and other immunochemical methods
    • genetic analyses including nucleic acid amplification
    • chromatographic, electrophoretic and spectroscopic physico-chemical methods

 
 
 
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