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Health Center » In The News » FDA Questions of the Week

How do biological products (biologics) differ from conventional drugs?

February 03, 2006

 

Answer:

In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Biological products include vaccines, human tissue, blood, and blood products. Biologics, including those manufactured by biotechnology, tend to be more heat sensitive and susceptible to microbial contamination than drugs. Therefore, it is necessary to take steps to ensure a germ-free manufacturing environment when producing biological products.
Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available.
For more on biologics, see http://www.fda.gov/cber/index.html.

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