Biological products history

The norms for medicinal production are particularly stringent. Biological products are composed of complex molecules, produced by cell lines with a relatively recent history, and difficult to characterize. Tests performed only on the final product do not guarantee consistency of production. The purification procedures should be planned and validated for the removal of potential contaminants from diverse sources cells, culture media, equipment, and reagents used in the purification or even degradation products derived from the protein itself. There are examples of products with unexpected risks that have caused serious problems such as blood contamination by HIV-1 virus between 1980 and 1985 (Bloom, 1984) or the presence of residual infectious viruses in the poliomyelitis vaccine due to inefficient inactivation (Lubiniecki et al., 1990). 

CBER. Science and the Regulation of Biological Products From a Rich History to a Changing Future 6 (2001). http //www.fda.gov/cber/inside/centscireg.htm... 

Help in understanding the scope of the investigations required may come from looking back at the history of what were once called biological products and are now more accurately termed products of biotechnology or biopharmaceuticals. ... 

Contamination of biologicals by viruses is not just a theoretical possibility. This has been documented throughout the history of biologicals production. Human growth hormone, blood-derived products, and monoclonal antibodies are typical examples. 

Biological products have a longer history than is generally assumed. At one time small pox accounted for 10% of deaths in some countries. The development of cow pox vaccination in 1796, and later the Variocella vaccine, has led to small pox being the only infectious disease ever to have been eradicated from the planet the final outbreak was after a laboratory accident in 1979, leading to a small number of cases. 

Estuary — A partly enclosed coastal body of water in which freshwater, usually originating from a river, is mixed with and diluted by seawater. Estuaries are generally considered more biologically productive than either adjacent marine or freshwater environments and are important areas in the life history of many fish and wildlife resources. 

Diester-Haass, L. Zahn, R. 1996. Eocene-Oligocene transition in the Southern Ocean history of water mass circulation and biological productivity. Geology, 24, 163-166. 

Soleas GJ, Diamandis EP, Goldberg DM. Wine as a biological fluid history, production, and role in disease prevention.] Clin Lab Anal 1997 11 287-313. 

As before, cell and tissue biological products are not such modern inventions as is commonly perceived. The history of blood transfusion is beyond the scope of this chapter, but was responsible for establishing some of the fundamental concepts in this area. Organ transplantation is both routine and seriously limited in its capacity by the paucity... 

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