The standardisation and control of endocrine therapeutics dates back to the earliest days of biological standardisation with the first International Standard for insulin prepared in 1925. Current activities focus on the gonadotrophin reproductive hormones, endocrine modulators of the growth axis and other peptide hormones. The section is responsible for a large catalogue of WHO International Standards and provides advice to manufacturers and regulatory organisations on the potency assessment of important therapeutic glycoproteins such as EPO, FSH and hCG and also peptide hormones such as growth hormone and insulin. The section also serves as an OMCL for the post-marketing surveillance of licensed endocrine medicines as part of the EU’s centrally authorized product testing programme. These testing activities extend to product characterization and potency assessment on a contractual basis. Underpinning these activities is a significant programme of collaborative research and development. Details of the section’s activities in the diagnostics field can be found here.

Image: Insulin hexamer (Chang et al, Biochem, 1997).