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The discovery, development and manufacturing of biologics has transformed modern medicine and patient care with entirely new types of human therapeutics, and Amgen has been at the forefront of this revolution.
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 realised 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.
A medicine is a therapeutic substance used for treating, preventing, or curing disease. The most familiar type of medicine is a chemical compound contained in a pill, 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, often referred to as biotech 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 too large and too intricate to make using chemistry alone. Instead, 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.
In general, any medicine made with or derived from living organisms is considered a biotech therapy, or biologic. A few of these therapies, such as insulin and certain vaccines, have been in use for many decades. 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 realise 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 Australia, the Therapeutic Goods Administration manages that responsibility.
