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Information @ a Glance

General
  • Insulin is often described as being either 'natural' ('animal') or 'human'. The sequence of amino acids (building blocks that make up the protein) is slightly different in insulins from different species. The insulin that humans make differs from that which pigs and cows make. Porcine insulin has one different amino acid and bovine insulin has three different amino acids.
  • Insulin is produced by beta cells in the pancreas and is the most important hormone in the body to regulate blood glucose levels. A partial or complete lack of insulin causes diabetes, which, untreated, is often fatal by the teenage years. Before insulin was discovered, diabetes was managed through diet, which allowed patients to survive, but generally for just a few years after diagnosis.

Manufacturing Process

  • Synthesizing human insulin is a multi-step biochemical process that depends on basic recombinant DNA techniques and an understanding of the insulin gene. Manufacturers manipulate the biological precursor to insulin so that it grows inside simple bacteria. While manufacturers each have their own variations, there are two basic methods to manufacture human insulin.
  • A leading manufacturer of life-saving products like heparin, gonadotrophins and insulin, produced from animal tissues using biochemistry pays special attention to the source of the materials to avoid contamination with pathogenic microorganisms or toxic substances. Their manufacturing processes have undergone virus validations - studies in which virus removal is proven - just in case a virus is present despite all precautions.

Applications & Technology

  • The dose of insulin used to obtain diabetic control was reduced by 7% in 108 patients treated solely with very pure porcine insulin from the start of insulin treatment when compared with 108 matched patients who had received conventional insulins. In 117 patients whose treatment had been changed from conventional bovine or bovine-porcine insulin to very pure porcine insulin the dose was reduced by 9%.
  • Insulin is synthesized as a larger precursor, preproinsulin , which is rapidly cleaved to proinsulin. The conversion of proinsulin to insulin is then a relatively slow process, which is thought to commence in the Golgi apparatus and continue into the maturing secretory granule.
  • These factors led researchers to consider synthesising Humulin by inserting the insulin gene into a suitable vector, the E. coli bacterial cell, to produce an insulin that is chemically identical to its naturally produced counterpart. This has been achieved using Recombinant DNA technology. This method  is a more reliable and sustainable method than extracting and purifying the abattoir by-product

Market

  • Canada led the world of biotechnology in 1921 when Banting and Best extracted a biologically active hormone from the pancreas of dogs. This Nobel Prize-winning work led to the isolation of insulin, which has been used for the treatment of Type 1 diabetes mellitus ever since. It is estimated that the present world capacity for cell culture production stands at 475,000 litres, 75 per cent of which is controlled by biopharmaceutical companies and the remainder by contract manufacturers.
  • Over 150 biopharmaceuticals have now been approved for human therapeutic use. This drives the annual global market for biopharmaceuticals to over $30 billion US 1,2. However, this success rate would not have been possible without the incorporation of animal cell cultures into the armoury of technologies for biomanufacture.

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