Biopharmaceuticals are drugs produced using biotechnology, not extracted from a native source or synthesized chemically. They are created using living organisms, such as modified microbes or transgenic cows, and require specialized equipment and safety cleanrooms. Biopharmaceuticals include blood factors, hormones, vaccines, and monoclonal antibodies. They are extensively tested for safety and efficacy before gaining approval for sale. The first biopharmaceutical was artificial human insulin in 1982, and the industry has since boomed due to advances in laboratory science. Biopharmaceuticals tend to be safer and more reliable than native compounds.
Biopharmaceuticals are drugs produced by the means of biotechnology. There are several ways such drugs can be produced, but the key distinction between them and other drugs is that they are not extracted from a native source or synthesized with chemical reactions. Instead, they are created with the use of living organisms that may have been modified to produce the desired compound. This requires the use of specialized equipment and safety cleanrooms that protect the integrity of pharmaceutical compounds as they are manufactured and packaged.
A classic method of producing biopharmaceuticals involves the use of a bioreactor, a container that is used to create tightly controlled conditions that facilitate the growth of a particular organism. In a bioreactor, drugs can be produced by organisms that generate biopharmaceuticals as a byproduct of their life cycle, often because these organisms have been modified to produce specific proteins and nucleic acids. Both cell cultures and modified microbes can be used in bioreactors to produce drugs and compounds that can be used in the production of pharmaceuticals.
Genetic modification of plants and animals can also be used to produce biopharmaceuticals. Transgenic cows can be engineered, for example, to secrete a specific compound in their milk. The practice of using transgenic organisms to manufacture pharmaceuticals has been controversial in some regions of the world, for reasons ranging from ethical concerns to concerns that such organisms could interbreed with conventional organisms and become contaminated.
A variety of substances can be produced using biopharmaceutical techniques, including blood factors, interferons, hormones, vaccines and monoclonal antibodies. When researchers develop new biopharmaceuticals, they typically file for patents to protect their inventions and process, and go through a series of steps to gain approval so their drugs can be sold on the open market. These steps involve extensive testing for safety and efficacy, to confirm that the drugs work as claimed.
The first biopharmaceutical to hit the market was artificial human insulin, released in 1982 for use by diabetics. The biopharmaceutical industry boomed after the 1980s, thanks to growing interest in additional medical treatments and advances in laboratory science that made new developments possible. An advantage of such drugs, especially as an alternative to native compounds, is that they tend to be safer and dosing is extremely reliable, because the manufacturing conditions are very tightly controlled.
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