Recombinant DNA technology, also known as genetic engineering, played a pivotal role in the production of human recombinant insulin. This innovative process involves combining genetic material from different sources to create a desired product. In the case of insulin, the human insulin gene is inserted into a host organism, such as bacteria or yeast, which then acts as a factory for producing insulin. Diabetes, also known as diabetes mellitus, is a chronic metabolic disorder characterized by high blood sugar levels. It happens when the body either does not produce enough insulin or is unable to effectively use the insulin it produces. Insulin is a hormone produced by the pancreas that helps regulate the amount of sugar (glucose) in the bloodstream and allows it to enter cells to be used as energy.
One of the significant advantages of human recombinant insulin over earlier forms of insulin is its decreased risk of allergic reactions. Before its introduction, insulin was derived from animal sources, primarily porcine (pig) or bovine (cow) pancreases. These animal-derived insulins often contained impurities and slight variations in structure that could trigger immune responses in some individuals. With the advent of it, synthesized to be identical to the insulin naturally produced by humans, the risk of allergic reactions diminished significantly.
Insulin has emerged as a significant player in the pharmaceutical industry, driven by the increasing prevalence of diabetes and the growing demand for safe and effective insulin therapies. It is a synthetic form of insulin produced using genetic engineering techniques, making it a game-changer in diabetes treatment. The global Human Recombinant Insulin Market is estimated to be valued at US$ 36,134.5 million in 2022 and is expected to exhibit a CAGR of 7.3% during the forecast period (2022-2030).
The production of human recombinant insulin begins with the isolation of the insulin gene from human DNA. Researchers identified the specific sequence of DNA responsible for coding insulin and inserted it into a circular piece of DNA called a plasmid. This plasmid is then introduced into a host organism, such as Escherichia coli (E. coli) bacteria or Saccharomyces cerevisiae (brewer’s yeast), which act as miniature insulin factories. Once inside the host organism, the plasmid containing the insulin gene replicates along with the organism’s own DNA. As the host organism grows and divides, it produces large quantities of insulin protein, which can then be harvested and purified. The purification process involves separating the insulin protein from the other cellular components of the host organism and removing any impurities to ensure a safe and pure final product.
Human Recombinant Insulin has several distinct advantages compared to its predecessors. Firstly, its production is scalable, allowing for the mass production of insulin to meet the growing demand worldwide. Additionally, recombinant insulin offers a consistent and predictable supply, reducing the risk of shortages or batch variations that were common with animal-derived insulins. It provides improved glycemic control for individuals with diabetes. The purity and consistency of this synthetic insulin enable more accurate dosing, ensuring that patients receive the appropriate amount of insulin to manage their blood sugar levels effectively. By closely mimicking the body’s natural insulin, recombinant insulin helps individuals with diabetes achieve better glucose regulation, reducing the risk of acute complications such as hypoglycemia or hyperglycemia.
Moreover, the development of human recombinant insulin paved the way for the advancement of insulin analogs. Insulin analogs are modified forms of insulin designed to mimic the body’s natural insulin secretion patterns more closely. These analogs have different pharmacokinetic properties, allowing for greater flexibility in dosing regimens. This has further improved the management of diabetes, providing patients with greater control over their blood sugar levels and enhancing their overall quality of life.
Since its introduction, human recombinant insulin has become the gold standard in diabetes treatment. It has revolutionized diabetes care, offering improved safety, efficacy, and accessibility compared to previous insulin formulations. The development of this synthetic insulin not only transformed the lives of individuals with diabetes but also spurred further advancements in biotechnology and genetic engineering. However, it is important to note that even with the availability, challenges still exist in diabetes management. The rising prevalence of diabetes, coupled with access and affordability issues, remains a global concern. Efforts must continue to ensure widespread availability and promote equitable access for all individuals in need.
