Biopharmaceuticals are drugs produced by means of biotechnology. These drugs can be made in a variety of ways, but the main difference between them and other drugs is that they are not derived from natural sources or synthesized through chemical reactions. Instead, they are created using living organisms that may have been modified to produce the desired compounds. This requires the use of specialized equipment and clean rooms to ensure safety and thus protect the integrity of pharmaceutical compounds when they are produced and packaged.
A classic approach to making biopharmaceuticals involves the use of bioreactors, which are containers used to create tightly controlled conditions that promote the growth of specific organisms. In a bioreactor, drugs can be produced by organisms that produce biological drugs as a by-product of their life cycle, often because the organisms have been modified to produce specific proteins and nucleic acids. Both cell cultures and modified microorganisms can be used in bioreactors to manufacture drugs and compounds that can be used in pharmaceutical production.
Genetic modification of plants and animals can also be used to make biological drugs. For example, genetically modified cows can be designed to secrete specific compounds in their milk. The use of GENETICALLY modified organisms to produce medicines has been controversial in some parts of the world, for reasons ranging from ethical concerns to concerns that such organisms could hybridize with conventional organisms and become contaminated.
A variety of substances can be produced using biopharmaceutical technologies, including blood factors, interferons, hormones, vaccines, and monoclonal antibodies. When researchers develop new biologic drugs, they typically apply for patents to protect their inventions and processes and seek approval through a series of steps so that their drugs can be sold on the open market. These steps involve extensive testing of safety and efficacy to confirm drug efficacy, action, and safety.
The biopharmaceutical industry exploded after the 1980s. With the progress of laboratory science, the research and development and production of innovative drugs such as gene drugs, targeted drugs, and small molecule drugs have become increasingly mature.
