Biomm’s technology enables the large scale production of recombinant human insulin complying with the standards and requirements of the World Health Organization, the US Food and Drug Administration and other regulatory authorities. The main steps of the process are described below:

• A DNA fragment containing instructions to express the insulin precursor (proinsulin) is introduced into a microorganism (E.coli).
• This microorganism grows in a fermenter and, under controlled conditions, is induced to express the desired protein;
• The proinsulin precipitates in the form of inclusion bodies inside the cells, which are subsequently disrupted.
• After being separated from the cell debris, the proinsulin is transformed into insulin and purified in several stages. First, the intramolecular bonds, mismatched disulfide bridges, are disrupted and, later on, in a renaturation step, they form properly.
• Afterwards, the renatured proinsulin is purified and converted into insulin, by enzymatic and chemical reactions and submitted to other purification steps such as ion-exchange, RP-HPLC and crystallization, leading to the insulin crystal which is then formulated.