The dynamics of Wertbestimmung.
The procedure of Wertbestimmung played a vital role in the implementation of serum therapy and the standardization of mass-produced pharmaceuticals. In fin-de-siècle Germany, a legal framework was put in place to guarantee serum quality and safety and to minimize any associated public health risks. Because the sera were biological remedies, it was difficult to produce them in uniform quality and the procedure of Wertbestimmung, i.e. determining the potency of the serum based on an objective and comparable value, was extremely complex. Various agents such as bacteria cultures, serum hosts, or test animals had to be regulated. In the years after 1895, numerous efforts to stabilize the procedures of Wertbestimmung were undertaken by serum producers and members of the state-run survey institute responsible for overseeing serum production. Despite efforts to stabilize the framework and to generate a reliable reference system, the framework's environment and agents were in constant flux: new producers entered the market and procedures were expanded to include other biologicals as well. The article describes the dynamics involved in the sustained efforts to maintain a stable framework in the face of constant alterations between 1895 and the 1920s.
Hüntelmann
Axel C
AC
Institute for the History of Medicine, Ruprecht-Karls-University, Heidelberg.
D000818:Animals; D001681:Biological Assay / Q000266:history*; D004353:Drug Evaluation, Preclinical / Q000266:history / Q000592:standards; D005858:Germany; D049672:History, 19th Century; D049673:History, 20th Century; D006801:Humans; D007106:Immune Sera / Q000266:history*; D007880:Legislation, Drug / Q000266:history; D011786:Quality Control
D007106:Immune Sera