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.
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.
ACTIVE PHAMACEUTICAL INGREDIENTS (APIs)
BioGenomics has a state-of-the-art facility for manufacturing of bulk APIs. These APIs are of highest quality and meet compendia qualities (wherever applicable).
BULK PRODUCT FORMULATION
BioGenomics facility is equipped to supply bulk formulations of biosimilars so that these could be fill-finished at appropriate facilities.
FINISHED PRODUCT FORMULATIONBioGenomics facility has Aseptically Processed Injectable Formulations (APIF) facility in Puducherry, India for undertaking clinical trial production as well as commercial production of small volume parenteral products derived from biotech processes for local as well as export submissions / markets.
The key objectives behind the facility are as follows.The facility is designed for producing vials, prefilled syringes and cartridges on campaign basis.
The facility is designed for biotech derived products. This formulation portions is located adjacent to the main biotech API facility. The facility is designed with full flexibility to produce all the presentations of pipeline products.
With fully integrated ‘Bench to Manufacturing’ facilities, BioGenomics ensures a quick turnaround, adaptive technology and is capable of full-scale manufacturing.
BioGenomics is consistently able to meet and exceed all regulatory standards in its products, processes and facilities.
Biosimilars Commercialization Strategy
BioGenomics is actively seeking global partners for the development and commercialization of our biosimilars. Our strategy is to establish proof-of-concept in humans in Indian clinical trials and generate data to satisfy global regulatory and commercial standards in partnership or licensing agreements with strategic partners.
Please contact business.development[at]BioGenomics.co.in for further information.
Biosimilars Developmental and Regulatory Program