BIOTECHNOLOGICAL ROUTES FOR INSULIN PRODUCTION

Abstract

Insulin is a peptide hormone produced by β-cells of the Islets of Langerhans in the pancreas and plays a central role in regulating blood glucose homeostasis. Historically, insulin therapy relied on extraction from animal pancreases, but this approach was limited by supply constraints, variable purity, and immunogenic reactions. The introduction of recombinant DNA technology in the late 20th century transformed insulin production by enabling biosynthesis in microorganisms such as Escherichia coli and Saccharomyces cerevisiae. These advances allowed the large-scale production of highly purified human insulin and eliminated dependence on animal sources. This study reviews the evolution of insulin production methods, from animal-derived extraction to recombinant biosynthetic approaches, including the development of proinsulin-based systems and yeast expression platforms. Furthermore, it examines the structural and functional properties of insulin, its biosynthesis, receptor interactions, and metabolic effects on carbohydrates, lipids, and proteins. Special attention is given to insulin analogues, including rapid-acting (Humalog, NovoLog, Apidra) and long-acting (Lantus, Levemir) formulations, which were developed through targeted amino acid modifications to improve pharmacokinetic profiles and therapeutic outcomes. Recombinant insulin and its analogues have significantly improved diabetes management by providing greater safety, consistency, and flexibility in treatment. Additionally, innovations such as insulin pens and advanced delivery systems have enhanced patient adherence. Overall, the development of recombinant insulin represents a major milestone in biotechnology and has fundamentally reshaped modern diabetes therapy.