Origin and application

Application

lnsulin is a key component in serum-free growth media for mammalian cells, used for the manufacturing of monoclonal antibodies, virus vaccines, gene therapy products and other biological drugs. It stimulates the proliferation of cells.

Origin of Recombinant lnsulin

The yeast organism used to produce our recombinant insulin does not contain genes or express antigens of livestock or poultry disease agents, and is neither stored nor grown in media containing animal raw material. It is considered to be virologically safe, and the risk of transferring BSE agents to the media or reagents in which Novo Nordisk Human Insulin is a component is negligible, since:

• No animal component is used in the manufacturing process
• A recombinant enzyme is used in the process
• The production strain for manufacture is yeast, which is not the natural host for mammalian viruses

Residual Solvents

lnsulin Human AF complies with ICH Q3C Note for Guidance on residual solvents. The solvents used are added earlier in the process and are removed during the following process steps, and the residual solvent levels comply with the limits established in ICH Q3C.

Solubility

lnsulin is a small (5,8 kDa) hydrophobic molecule and is easily dissolved in a buffer at relatively low pH, compared to the pI value of insulin (pI = iso electric point). At neutral pH, it will take longer to dissolve. The pI of the lnsulin molecule is 5,8.

Therefore it can be seen that when dissolving the lnsulin at low pH and adding it to a media at neutral pH (around pH 7,5), it precipitates for a short moment, due to the fact that pH is passing the pI value of lnsulin.

It is recommended to add dissolved insulin to the media while stirring.Instructions for dilution of Insulin Human AF can be provided upon request to Novo Nordisk Pharmatech.