Recombinant Human Insulin

Recombinant Human Insulin, often referred to as synthetic insulin, is a form of insulin that is produced in a laboratory. It’s created by inserting the human gene for insulin into a host organism, typically a bacterium or yeast, which then produces insulin for human use. This process, known as recombinant DNA technology, has revolutionized the production of insulin, making it more accessible and affordable for those with diabetes. The resulting product is structurally identical to the insulin produced by the human pancreas, and functions in the same way to regulate glucose levels in the blood. It’s a key example of how biotechnology can be applied to improve human health.

Transfer of the end-to-end technology available in GMP-like environment.
From a single product Insulin Precursor, produced from the yeast cells, three final products could be obtained: Recombinant Human Insulin, and long-acting insulins Detemir and Degludec.

Recombinant human Insulin is produced in Pichia pastoris using an expression vector pPIC9K (Cat. No. V175-20, Invitrogen, CA) driven by the AOX promoter and
induced by methanol.
Production: 10L fermentation (5 day methanol induction) yields around 30 g of Insulin
precursor.
The insulin precursor is purified from the culture supernatant followed by a trypsin-transpeptidation reaction and further cation exchange chromatography.
Final yield of the process is around 35%. The purity of the product is around 98%
as determined by HPLC analysis.

Diabetes Management: rHI is used to regulate the cellular uptake, utilization, and storage of glucose, amino acids, and fatty acids, and inhibits the breakdown of glycogen, protein, and fat1. It is a life-saving medicine for more than 420 million people living with diabetes worldwide.
Biomanufacturing: rHI is a key component in serum-free growth media for mammalian cells. It is used as a supplement in the cell culture media for several cell lines, such as CHO, HEK293 or Sf9, for the manufacturing of monoclonal antibodies, virus vaccines, or gene therapy products.