Questions of quality: the Danish State Serum Institute, Thorvald Madsen and biological standardisation

The opening of the Danish State Serum Institute (SSI) in Copenhagen on 9 September 1902 was a festive occasion, attended by renowned figures from the wider bacteriological community including the German scientists Paul Ehrlich, Carl Weigert, and Julius Morgenroth, future Nobel prize-winner Svante Arrhenius from Sweden, Ole Malm and Armauer Hansen from Norway, and William Bulloch and German Sims Woodhead from England.1 Established as a national resource for the production of diphtheria antitoxin, the SSI was from its inception concerned to deliver a quality product at a minimum price, and to link pharmaceutical production with research into, and further development of, biological products. In the course of the twentieth century, the institute acquired an international reputation for the quality of its products and its cutting edge research, and, in the 1920s, achieved international authority as the League of Nations Health Commission’s central laboratory for the preservation and distribution of all standard sera and bacterial products.2 The rise of the SSI to international prominence came about through a combination of factors, personal, scientific and political, but above all, perhaps, from its early association with questions of quality in the production of the new generation biological medicines, of which diphtheria antitoxin was the first to emerge.