Biocon's human insulin facility employs several sophisticated technologies and equipment . The human insulin manufacturing process begins by fermenting a methylotrophic yeast wherein expression is controlled by the rate of dosing alcohol. The cells are harvested using a continuous centrifuge and the product-containing liquid is processed by large-scale chromatography, bioconversion and crystallization. The lyophilized bulk product is obtained after multiple purification steps involving high pressure chromatography which can separate closely eluting impurities. The final processing steps are carried out in high quality, electropolished, steam sterilizable equipment in a controlled environment with restricted entry through multiple airlocks. The entire process is largely automated and monitored continuously in a central control room by trained personnel.
Investments made in the human insulin facility can support other products such as in Biocon’s insulin analogs. The expertise developed in protein processing, formulation and aseptic fill-finish is also leveraged for commercializing therapeutic peptides.
Insulin Delivery Devices
Biocon generic insulin business is complemented by a comprehensive delivery device basket. Biocon offers re-usable injector devices branded INSUPEN® and INSUPEN® EZ, developed along with Haselmeier, to patients.