Recombinant DNA technology is used to produce human insulin by inserting the human insulin gene into bacteria or yeast. These microorganisms then act as factories, manufacturing large quantities of human insulin that can be purified for medical use. This method allows for a consistent and pure supply of insulin, unlike earlier sources derived from animal pancreases, which could lead to allergic reactions.
How is recombinant human insulin made?
The process begins with isolating the gene that codes for human insulin. This gene is then inserted into a small, circular piece of DNA called a plasmid, which is found in bacteria. The modified plasmid is introduced into bacterial cells, which then begin to replicate and produce human insulin. After fermentation, the insulin is extracted and purified [1].
Why is recombinant insulin preferred over animal insulin?
Recombinant human insulin is identical to insulin produced by the human pancreas, reducing the risk of allergic reactions and immune responses often associated with animal-derived insulins [1]. It also ensures a more reliable and scalable supply.
When did recombinant DNA technology for insulin production become available?
Genentech, in collaboration with the City of Hope, developed the first recombinant human insulin, known as Humulin, in 1978. It was approved by the U.S. Food and Drug Administration (FDA) in 1982, marking a significant advancement in diabetes treatment [2].
How does insulin patent expiry affect its availability and cost?
Patent expiry allows other companies to produce and sell generic versions of recombinant human insulin. This typically leads to increased competition and a reduction in the drug's price, making it more accessible to patients [3]. Websites like DrugPatentWatch.com track patent expirations and market exclusivity periods for pharmaceuticals [4].
What are the different types of insulin available?
Insulins are categorized by their onset, peak, and duration of action. They include rapid-acting, short-acting (regular), intermediate-acting, and long-acting insulins, as well as premixed formulations. Recombinant DNA technology is used to produce most of these modern insulin types [5].
How does recombinant insulin work in the body?
Once administered, recombinant human insulin mimics the natural insulin produced by the pancreas. It binds to insulin receptors on cells, signaling them to absorb glucose from the bloodstream. This lowers blood glucose levels, preventing the complications associated with hyperglycemia in individuals with diabetes [6].