Insulins & Analogs
Biocon’s Pichia pastoris platform for expression of recombinant protein is our proprietary technology, which is applied in the rh-insulin and insulin analog product lines. We were the first company in the world to have successfully commercialized the large-scale manufacture of human insulin, using this proprietary 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 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
Our 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.
Our portfolio also includes Basalog One™, our state-of-the-art Insulin Glargine disposable pen, which we launched in India in FY16 and in Japan in early FY17. The pen has been designed in collaboration with Becton Dickinson & Co., a leading global medical devices company and is specially customised for Biocon.
We set up a 100,000 square feet world class devices assembly facility in Bangalore in FY16. Equipped with the latest Swiss technology and approved by the Japanese regulator, PMDA, this facility is producing products that meet the highest quality and safety standards.
Biocon's Insulins Facility in Malaysia
Biocon has set up Asia’s largest integrated insulins manufacturing facility in Malaysia at an investment of over US$ 250 Mn which is the highest overseas investment in the Malaysian biotech sector till date. Biocon Malaysia currently employs a team of over 400 people at this state-of-the-art facility. This is Biocon’s first overseas biopharma manufacturing and research facility.
The facility manufactures the Drug Substance for Biocon’s range of rh-insulin and insulin analogs as well as Drug Products in vials and cartridges. It has received the cGMP certification from the National Pharmaceutical Control Bureau (NPCB), Malaysia in 2015. The rh-Insulin formulations manufactured at this facility have been approved by the Drug Control Authority, Ministry of Health, Malaysia. The product registrations in various emerging markets and regulated markets for rh-insulin and insulin analogs are in progress.