Biologics Timeline
Standardization of biological medicines had become a major worldwide operation
1900s
1897
Paul Ehrlich, a German scientist, published his memoir, ‘The potency estimation of diphtheria antiserum and its theoretical basis’, which laid the foundation for all future work on biological standardization
1901
Ten children died from contaminated diphtheria
antitoxin.
Biologics Control Act (Public Health Service Act)
- authorized biologics regulations
- required licensing of
manufacturers and establishments
- regulates the sale of viruses, toxins, serums, etc.
1902
(Image Citation 11)
(Image Citation 11)
1906
Food, Drug and Cosmetic Act passed
1921
Insulin was discovered by F. G. Banting and C. H. Best in Toronto, and its vital use in the treatment of diabetes was immediately apparent
(Image Citation 12)
(Image Citation 13)
Medical Research Council
(MRC) established, it urged
for ‘the establishment of a Government laboratory for biological standardization’
1913
(Image Citation 14)
1921
Thorvald Madsen organized
the first international meeting on biological standards
(Image Citation 15)
(Image Citation 16)
1923
A Permanent Commission on Biological Standardization established by the Health Committee
(Image Citation 17)
1925
the Therapeutic Substances Act defined ‘biological’ as ‘a substance used in the treatment or diagnosis of disease that cannot be completely characterized by physicochemical means alone, and which therefore requires the use of some form of bioassay to guarantee its identity, potency or efficacy’.
(Image Citation 18)
1930
PHS Hygienic Lab became the National Institute of Heath
(Image Citation 19)
1950s
begin to control active immunization treatments, or vaccines, as British companies began to make the inactivated vaccine against poliomyelitis,
which had been developed in
the USA
(Image Citation 20)
1955-1972
Biologics regulated within the National Institute of Health
1984
Georges Kholer, Cesar Milstein, and Niels kaj Jerne shared the Nobel Prize in Medicine for the development of the monoclonal antibody
(Image Citation 22)
(Image Citation 21)
2006
certain responsibilities for biologics development reorganized into The Center for Drug Evaluation and Research
(Image Citation 23)
