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Biological drugs target a diverse array of hormone‐mediated systems. Hormones are intercellular messengers that can be categorized as steroids, polypeptides, or amino acid derivatives. Steroids include estrogens, androgens, and mineral corticoids. Polypeptides include insulin and endorphins, and amino acid derivatives can include epinephrine, norepinephrine, adrenaline, and noradrenaline.² The development of a therapeutic insulin has been one of the most important pharmaceutical endeavors to date; a timeline provided in Table 3.6 demonstrates how insulin's discovery and manufacturing have shaped modern medicine and drug development.

One of the most impactful scientific breakthroughs in the development of insulin was the ability to produce human insulin on an industrial scale using rDNA techniques. Prior to this, in the 1970s, diabetic patients were injected with insulins derived from animal sources. Mass‐produced human insulin made from rDNA could be produced uniformly and carried the potential to alleviate shortages inherent in animal‐insulin supply. While insulin was the first drug produced using recombinant technology, the capability extends to most of the biological drugs developed to date and continues to progress biotechnological and pharmaceutical sciences today.

Table 3.6 Insulin: timeline of discovery and manufacture.

Source: Adapted from https://www.diabetes.co.uk/insulin/history‐of‐insulin.html.²²

1869 – The Islets of Langerhans cells are discovered in the pancreas

1901 – The Islets of Langerhans are identified as cells that produce insulin

1916 – Pancreas extract is found to lower blood sugar when given to diabetic dogs

1921 – Studies show that pancreas removal in dogs results in the symptoms of diabetes; cow pancreas extract demonstrated improvement in the dog's health when given and was termed “insulin”

1922 – A young boy with type 1 diabetes lives for 13 years beyond typical mortality as the first recipient of medical insulin; Eli Lilly becomes the first insulin manufacturer

1936 – The addition of protamine is found to prolong the action of insulin

1950 – Intermediate acting insulin (NPH) is marketed by Novo Nordisk

1955 – Insulin becomes the first protein to be fully genetically sequenced

1963 – Insulin becomes the first human protein to be chemically synthesized

1978 – Genentech makes the first synthetic human insulin via recombinant DNA techniques, which is the first human protein to be manufactured using biotechnology

1982 – Synthetic insulin is renamed as human insulin to better differentiate from animal sources

1996 – Eli Lilly develops the first insulin analogue, which is genetically modified to change pharmacokinetics