Biologics
Biological medicines have been used since ancient times and are plant-derived. Healing plants were grown next to the temples of the ancient Egyptians and herbs to which therapeutic properties are attributed are still cultivated today. Phytotherapy still plays a considerable role in healthcare, although the safety and efficacy of applied herbal medicine procedures have not been proved using modern methods from evidence-based medicine. Animal tissue extracts are still used as biological medicine. More than 100 years ago it was found that pituitary extracts affect growth. Maurice Raben first isolated pituitary human growth hormone (pit-hGH) from human pituitaries collected at autopsy (1951) and used it in GH deficient patients (1958). Soon afterwards, a period of therapeutic use of pituitary-derived hGH, which has lasted for more than 20 years, began.

In the late 1970s, after many years of scientific research into DNA technology, the techniques of cutting at specific sites and replicating and synthesising DNA molecules greatly improved, and inserting specific DNA into bacterial or mammalian cells became possible. The host cell replicates inserted DNA in a natural way and synthesises the protein coded by the DNA. From that time on, it was possible to obtain active components of complex high-molecular-weight molecules for medical purposes. Continuous development of analytical methods and biological assays improved biotechnology methods, and thus an increasing number of complex molecules could be produced. Industrial manufacturing started in the early 1980s by cultivating genetically modified micro-organisms or cells, which was followed by purification of an active ingredient. Soon several important new drugs were patented; drugs obtained using this technique were called ‘biopharmaceuticals’ (see Figure 1). Insulin and GH were the first human hormones to be produced this way.