Standardization of biological medicines: the first hundred years, 1900–2000

  title={Standardization of biological medicines: the first hundred years, 1900–2000},
  author={Adrian F. Bristow and Trevor W. Barrowcliffe and D. R. Bangham},
  journal={Notes and Records of the Royal Society},
  pages={271 - 289}
The use of materials of biological origin in medicine has a long history. These materials, including tissue, organ and microbial extracts, blood and its derivatives, antibodies and hormones, share the feature that for much of the last century the ability to characterize and quantify the active substance was limited. Quantification of these substances depends on biological standardization, a discipline that was refined to a science by the Medical Research Council from the 1920s onwards, and… 

Figures and Topics from this paper

Assignment of quantities to biological medicines: an old problem re-discovered
  • A. Bristow
  • Computer Science, Medicine
    Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences
  • 2011
The science of ‘biological standardization’ has kept pace with developments in medicine and continues to allow the use of biological medicines in man to be controlled on the basis of common measurement systems.
The Role of Reference Materials in the Research and Development of Diagnostic Tools and Treatments for Haemorrhagic Fever Viruses
Following the Ebola outbreak in Western Africa in 2013–16, a global effort has taken place for preparedness for future outbreaks. As part of this response, the development of vaccines, treatments and
Fibrinolysis standards: a review of the current status.
  • C. Thelwell
  • Computer Science, Medicine
    Biologicals : journal of the International Association of Biological Standardization
  • 2010
Biologics in organ transplantation
  • E. Page, W. Dar, S. Knechtle
  • Medicine
    Transplant international : official journal of the European Society for Organ Transplantation
  • 2012
The armamentarium of clinical and preclinical biologics used for organ transplantation is reviewed, from depleting and IL‐2R targeting induction agents to costimulation blockade, B‐cell therapeutics, BAFF and complement inhibition, anti‐adhesion, and anti‐cytokine approaches.
International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab
This data provides the first scientific evidence that a classical standardization exercise allowing traceability of bioassay data to an international standard is also applicable to rituximab, however, it is submitted that this new type of international standard needs to be used appropriately and its role not to be mistaken with that of the reference medicinal product.
International reference preparations for standardization of biological medicinal products
  • P. Minor
  • Medicine
    Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz
  • 2014
International standards are prepared as materials assigned an arbitrary unitage for a biological activity by the Expert Committee on Biological Standardization of the World Health Organization and have proved valuable in assaying the activity of therapeutic biological medicines and in standardizing certain types of diagnostics.
Unfolding epidemiological stories: how the WHO made frozen blood into a flexible resource for the future.
  • Joanna Radin
  • Biology, Medicine
    Studies in history and philosophy of biological and biomedical sciences
  • 2014
The WHO network of collaborating centres on standardization and regulatory evaluation of vaccines.
'Wanted-standard guinea pigs': standardisation and the experimental animal market in Britain ca. 1919-1947.
  • R. G. Kirk
  • Political Science, Medicine
    Studies in history and philosophy of biological and biomedical sciences
  • 2008
Yardsticks of science: the origins and future of the international unit
  • J. Ferguson, C. Burns
  • Geography, Computer Science
    IEEE Instrumentation & Measurement Magazine
  • 2017
The field of tame laboratory animals having been nearly exhausted, it remains for the bolder spirits to discover methods in which a lion or elephant unit may be described.


Henry Hallett Dale, 1875-1968
  • W. Feldberg
  • Medicine
    Biographical Memoirs of Fellows of the Royal Society
  • 1970
Dale had no knowledge of any ancestors or relatives who had any kind of contact with science. An amusing but cranky cousin of Dale’s father, R. M. Dale, wasted much time in trying to fake an
The international contribution to the standardization of biological substances. I. Biological standards and the League of Nations 1921-1946.
  • W. Cockburn
  • Medicine
    Biologicals : journal of the International Association of Biological Standardization
  • 1991