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Amgen was one of the first companies to discover the potential of modern biotechnology for developing valuable medicines. Biologics have made a significant difference in the lives of patients with serious diseases. But what exactly is biotechnology? How are biotechnological medicines made? And what's next?
In 1919, Hungarian agricultural engineer Karl Ereky foresaw a time when biology could be used for turning raw materials into useful products. He coined the term biotechnology to describe that merging of biology and technology.
Ereky’s vision has now been realized by thousands of companies and research institutions. The growing list of biotechnology products includes medicines, medical devices, and diagnostics, as well as more-resilient crops, biofuels, biomaterials, and pollution controls. While the field of biotechnology is diverse, the focus of this guide is on biotechnology medicines.
The most familiar type of medicine is a chemical compound contained in a tablet or capsule. Examples are aspirin and other pain relievers, antibiotics, antidepressants, and blood pressure drugs. This type of medicine is also known as a small molecule because the active ingredient has a chemical structure and a size that are small compared with large, complex molecules like proteins. A small molecule medicine can be made by chemists in a lab. Most medicines of this type can be taken by mouth in solid or liquid form.
Biotechnology medicines are large molecules that are similar or identical to the proteins and other complex substances that the body relies on to stay healthy. They are made using living factories—microbes or cell lines—that are genetically modified to produce the desired molecule. A biotech medicine must be injected or infused into the body in order to protect its complex structure from being broken down by digestion if taken by mouth.
Most biologics were developed after the advent of genetic engineering, which gave rise to the modern biotechnology industry in the 1970s. Amgen was one of the first companies to realize the new field’s promise and to deliver biologics to patients.
Like pharmaceuticals, biologics cannot be prescribed to patients until their use has been approved by regulators. For example, in the United States, the Food and Drug Administration evaluates new medicines. In the European Union, the European Medicines Agency manages that responsibility.