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These studies suggest that insulin can be synthesized through chemical methods, recombinant DNA technology, and transgenic plants, with biosimilar and biosynthetic insulins showing bioequivalence and similar biological activity to native insulin, despite production complexities.
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The discovery of insulin in 1921 marked a significant milestone in medical science, transforming diabetes treatment from merely keeping patients alive to significantly improving their quality of life. This breakthrough has paved the way for extensive research into insulin synthesis and its applications in both healthy and pathological conditions.
Insulin is a complex peptide hormone composed of 51 amino acids arranged in two chains connected by three disulfide bonds. The chemical synthesis of insulin has been a challenging task due to its intricate structure and the need for precise folding and bond formation. Over the years, various strategies have been developed to chemically assemble insulin, contributing significantly to peptide synthesis chemistry. These methods have enabled the production of numerous insulin analogues with optimized structural and functional features, achieving synthetic efficiency comparable to recombinant DNA methods.
Recombinant DNA technology revolutionized insulin production by enabling the synthesis of human insulin in bacterial and yeast cells. The first successful production of human insulin using this technology involved cloning the A and B chains of insulin in Escherichia coli, followed by purification and correct disulfide bond formation . This method has been refined over the years, leading to the large-scale production of biosynthetic human insulin (BHI), which is identical in function to native human insulin .
The increasing global demand for insulin, driven by the rising number of diabetic patients, has necessitated the exploration of alternative production methods. Current manufacturing technologies, primarily using E. coli and Saccharomyces cerevisiae, face limitations in production capacity and cost. Transgenic plants have emerged as a promising alternative, offering a cost-effective and high-capacity production system for insulin. These plant-based systems can produce biologically active proinsulin with long-term stability, suitable for both injectable and oral delivery.
The expiration of patents for many insulin formulations has opened the market to biosimilar insulins, produced by new players using modern biotechnological methods. While these biosimilars may have subtle differences in structure and purity compared to the original insulins, their clinical relevance and biological effects are key considerations for market approval in regulated regions like the EU and the United States.
The synthesis and production of insulin have evolved significantly since its discovery, with advancements in chemical synthesis and recombinant DNA technology playing crucial roles. The development of biosimilar insulins and alternative production methods, such as transgenic plants, continues to address the growing demand for this vital hormone. These innovations ensure that insulin remains accessible and affordable for millions of diabetic patients worldwide.
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