Human Insulin & Biosimilars
Biocon is the first company to have successfully commercialized the large-scale manufacture of human insulin, using a proprietary methylotrophic yeast based technology. This resulted in the launch of our insulin brand, Insugen®, in 2004, representing our entry into the branded formulations market.
Biocon’s human insulin facility employs several sophisticated technologies and equipment used for the first time in India. 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 in Biocon’s research pipeline such as IN-105, the novel insulin conjugate for oral delivery and other insulin analogs. The expertise developed in protein processing, formulation and aseptic fill-finish is also leveraged for commercializing therapeutic peptides.
Biocon has also invested significantly in the development of other biosimilars such as granulocyte colony stimulating factor (GCSF), streptokinase, reteplase, human growth hormone, etc. using bacterial (E.coli) & yeast fermentations. These products are manufactured in a facility equipped to handle both intracellular & extracellular products and the entire upstream and downstream operations are carried out in clean rooms. The capability includes handling complex protein refolding unit operations for inclusion body based processes.