Biosimilars Program

BioGenomics has a very active biosimilars development program. Our recombinant DNA based technology platform can be adapted to a wide range of biopharmaceuticals. The first phase of the Biosimilars Development Program at BioGenomics has generated a pipeline of eight biosimilars. The second development phase is due to produce seven more products.

The entire process development is conducted completely in-house. At BioGenomics, a typical time frame for product development - from concept to scale-up is six months or shorter. BioGenomics is the first Indian company to successfully develop an indigenous Recombinant Human Insulin Program that relies entirely on proprietary clones/cell lines/technology for its drug development program in biosimilars.

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Our microbial-platform-based biosimilars program has been successfully scaled up at Puducherry, where our state-of-the-art manufacturing facility for E.coli based biopharmaceuticals is located. The platform technology for each of the biosimilars typically begins with fermentation, where there is over expression of the desired target protein. The cells are harvested and lysed to release expressed recombinant protein in the form of inclusion bodies. The inclusion bodies are washed, solubilized and folded. These solubilized folded inclusion bodies containing primarily, the target protein, is purified using column chromatographies, enzymatic conversions, and lyophilizations.

Our expertise in developing recombinant proteins ranges from synthesizing the coding sequence, using our indigenous process, formulation and aseptic fill-finish. BioGenomics has completed the development of recombinant Human Insulin and it analogs (long acting and short acting), Granulocyte Colony Stimulating Factor and its PEGylated forms, Interferon-2a and its PEGylated version amongst various other products.