International biological standardization in historic and contemporary perspective.

Abstract

Recounting the origination and development of the concepts and institutions to foster and control new and existing biological products is a fertile subject for historical review. It describes what was a necessary and functional activity that needed to be brought into being. The earliest examples of biologicals regulation were created by the eighteenth century inventors themselves and became progressively institutionalized by the creation of national control authorities which increased in number and sophistication during the past century. In 1948, the World Health Organization (WHO) was established and created biological standards and regulations as an advisory to member nations. This too has grown in sophistication and is now of central importance in the biologicals enterprise worldwide. The field of biological standardization and regulation can be viewed in its need and role to foster technological development and to assure that the products of that endeavour are worthy and are retained. In many respects, it is a tale of troubles, tragedies, and triumphs and this is recounted in the text.