Since the advent of recombinant DNA techniques, scientists have been exploring microbial cell factories for production of bio-pharmaceuticals. Human insulin industry is one of the world’s largest bio-pharmaceutical sectors delivering the essential tool in treating millions with type 1 & 2 diabetes.

Scientists at VMSRF have indigenously developed technology for yeast based expression of recombinant human insulin using Saccharomyces cerivesiae. This had considerable advantages over the earlier bacterial expression, with respect to protein folding, recovery aspects, as well as purity.

Breakthrough in research was achieved when the expression system was changed to Pichia pastoris, a methylotropic yeast capable of growing at very high cell density. Since the productivity of recombinant protein is a function of cell count, this system had multi-fold improvement in yield and techno-commercial feasibility of the whole process. After initial success of cloning, stage wise optimization was done on the sequence of gene construct, methods of cloning & selection and finally on fermentation and down stream processing, for maximum productivity. In-process and final product quality assurance protocols were developed using HPLC analysis. Bioactivity of the purified insulin was evaluated in vitro assays & in vivo animal experiments.

The technology is IPR protected and now being jointly developed with Bangalore based Bigtec Pvt Ltd, where process scale-up, product and technology characterization & validation are in progress.