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Health Center » FDA Questions of the Week

What is a biological product?

December 05, 2006

 

Answer:

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances. Or they may be living entities such as cells and tissues.

Biologics are isolated from a variety of natural sources -- human, animal, or microorganism -- and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

For more on biologics, see http://www.fda.gov/cber/index.html.

 

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