Gennova is dedicated to the development, production, and commercialization of bio-therapeutics to address life-threatening diseases across various indications. In our journey of development to commercialization, we have provided products of high-quality standards at an affordable price to the patients.
Incorporating recombinant DNA technologies together with innovative bio-manufacturing practices, Gennova has created a cost-effective solution for manufacturing and commercializing bio-cardiovascular, neurology, nephrology and oncology markets. The company manufactures its recombinant products using microbial, mammalian and mRNA-based platforms and has developed deep expertise in perfusion-based continuous manufacturing technologies.
Mammalian Platform
Mammalian Platform
Gennova has designed mammalian production cell lines that can survive more than 90 days in a perfusion-based bioreactor system which allows for a continuous bio-manufacturing approach. This process outpaces the product generated in the fed-batch system, is highly economical, has low risk and losses in case of failure and has low levels of process related impurities.
The benefit of this approach is demonstrated with our commercialized products Vintor® and Elaxim®. Gennova launched Vintor® a biosimilar of erythropoietin (EPO) in the Indian market and has maintained the leadership in the market.
The innovation in bio-manufacturing allowed the company to provide tenecteplase, a life‑saving drug to the Indian market. It is important to note that because of innovation in the bio-manufacturing processes, Gennova increased its production yields of Elaxim® by more than 100% within the same facility. To date, Elaxim® has benefitted ~300,000 patients around the globe.
Microbial Platform
Microbial Platform
Gennova’s innovation around high cell density fermentation and genetic manipulations for its microbial products have successfully culminated in the development and commercialization of filgrastim and its long-lasting pegylated version PEG-filgrastim, for which Gennova holds pole position in the Indian market. Gennova Biopharmaceuticals is one of the leading manufacturer of GCSF (Xgrast®-300) and PEG-GCSF (PEGEX®) in India.
Continuing its efforts on innovative pegylation processes, Gennova was the first Indian company to develop generic pegaspargase, HAMSYL®, and launch it in 2014 for use in acute lymphoblastic lymphoma (ALL) an orphan indication.
mRNA Platform
mRNA Platform
mRNA is used to produce proteins as vaccines or therapeutics in the cell, by utilizing body’s own translation machinery. mRNA-based vaccines are the ideal choice because of their rapid developmental and production timeline. mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and is degraded by standard cellular mechanisms. They are highly efficacious because of their inherent capability of being translated into proteins. Additionally, mRNA vaccines are fully synthetic and do not require a host for growth. Therefore, they can be quickly manufactured in a cost effective manner under cGMP conditions to ensure their “availability” and “accessibility” for mass vaccination on a sustainable basis.
Gennova has developed an mRNA-based vaccine against COVID-19 – GEMCOVAC®-19, which overcomes the limitations associated with the currently approved mRNA vaccines.
GEMCOVAC®-19 is stable at 2 – 8 °C and can be considered superior in terms of deployment in India and other developing nations (especially LMICs) compared to other approved mRNA vaccines. In GEMCOVAC®-19, the mRNA is bound on the surface of the nano-lipid emulsion (as opposed to it being entrapped in other mRNA vaccines using NLPs), thereby easing manufacturability and minimizing losses and makes the process scalable and amenable for technology transfer.
