What How Why

Gennova develops, produces, and commercializes bio-therapeutics and vaccines to address life-threatening diseases across various indications.

To date, Gennova has commercialized seven bio-therapeutics; 5 biosimilars, one generic, and one pioneering – ‘first in the world’ product across cardiovascular, neurology, nephrology, and oncology segments.

In the cardiovascular segment, Gennova launched the third-generation thrombolytic tenecteplase in 2007, under the brand name Elaxim® for acute myocardial infarction (AMI). For a decade since its launch, Gennova was the only manufacturer to commercialize a biosimilar version of tenecteplase in India successfully. To date, Elaxim® has been delivered to > 350,000 patients worldwide with published pharmaco-vigilance data available for 15,222 patients in 2013 and additional 7,668 patients in 2017.

Gennova is one of the key players in the nephrology sector. In 2007, Gennova was the 14^th Indian manufacturer to launch biosimilar of erythropoietin under the brand name Vintor®, and today Gennova holds a significant market share for this product.

Gennova has four products in the oncology sector – Emgrast-M® (sargramostim), Xgrast® (filgrastim), PEGEX® (pegylated filgrastim), and HAMSYL® (PEGylated L-Asparaginase). Gennova is the only Indian manufacturer to make biosimilar sargramostim. In 2014, Gennova was the first company to launch generic Pegaspargase (HAMSYL®) in India for use in acute lymphoblastic lymphoma (ALL), an orphan indication, at a competitive cost. Since its launch, it has benefited more than 3,000 patients.

Shedding off the biosimilar manufacturer tag, Gennova launched its first novel product in the neurology sector. Till August 2016, alteplase – a second-generation thrombolytic was the only approved treatment for acute ischemic stroke (AIS). In recent clinical trials conducted by Gennova, it has expanded the use of its tenecteplase for the indication of AIS. Gennova’s Tenectase® is a pioneering product, where first time globally, a 3rd generation thrombolytic was approved for stroke. Tenectase® was included in the list of drugs for emergency care for stroke management in the ‘Guideline for Prevention and Management of Stroke,’ issued by the Ministry of Health and Family Welfare, Govt. of India

Gennova manufactures its recombinant products using bacterial, yeast, and mammalian-based expression platforms.

Incorporating recombinant DNA technologies together with innovative bio-manufacturing practices, Gennova has created an efficient solution for manufacturing and successfully commercializing bio-therapeutics across cardiovascular, neurology, nephrology, and oncology markets.

The company manufactures its recombinant products using bacterial, yeast, and mammalian-based expression platforms and has developed deep expertise in perfusion-based continuous manufacturing technologies.

To boost the next-generation manufacturing technologies for bio-therapeutics production and the development of parallel innovating tools to reach patients, Gennova strives to improve and innovate continuously to respond effectively to healthcare challenges.

The state-of-the-art facilities, R & D capabilities, and knowledgebase development have empowered Gennova to take a product from bench to bedside/gene to market. Gennova has a team of experienced and capable scientists and technocrats who have developed capabilities across scientific, manufacturing, regulatory, clinical, and business arenas that have made it successful in the Indian market.

Through bio-manufacturing innovation, Gennova has successfully developed and standardized packed-bed perfusion technology in the upstream processing of full-scale commercial bio-manufacturing to produce tenecteplase. As the equipment footprint is dramatically smaller because of this innovative technological process, the required manufacturing facility’s size and the related capital costs were significantly reduced.

Carrying on its innovative efforts, Gennova moved towards continuous manufacturing by integrating the perfusion-based bio-reactor in the upstream to the periodic counter-current chromatography (PCC) in the downstream for next-generation manufacturing of its pipeline bio-therapeutics. This will further reduce manufacturing costs and increase the overall yield and process efficiency to compete in the market. Gennova has proven, not once but twice, that it can be market leaders by launching quality products at competitive prices.

To constantly ensure the quality, safety, efficiency, and higher-yield of bio-therapeutics, various mathematical process modeling approaches must be applied to control the process parameters; however, for longer-period control, it requires data-driven cognitive process models based on past manufacturing runs. With the help of artificial intelligence (AI) tools, Gennova has successfully utilized data from past manufacturing runs to establish neural network models to control and predict new-campaign manufacturing runs’ performance. Moreover, Gennova intends to employ machine learning (ML) algorithms to develop next-generation, data-driven automated bio-manufacturing processes to minimize manufacturing deviations to meet regulatory compliance and gain economical-benefits.

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. 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.

Innovation is central to Gennova’s continued success. This innovation comes from both its internal attributes, capabilities, external collaborations and synergistic partnerships.

Gennova is transforming healthcare by creating efficient and effective solutions for manufacturing and successfully commercializing bio-therapeutics across cardiovascular, neurology, nephrology, and oncology segments.

Through innovation-driven bio-manufacturing, Gennova became the first biotechnology company in India to launch the biosimilar of the third-generation thrombolytic protein, Tenecteplase, addressing the unmet need in cardiovascular diseases. Carrying on with its innovation to transform healthcare, Gennova launched Tenectase®, a pioneering work, where first time globally, a third-generation thrombolytic was approved for the indication of Acute Ischemic Stroke (AIS).

This innovation was recognized by the Department of Biotechnology (DBT), Govt. of India for the ‘Biotech product, process development and commercialization award 2019’. Additionally, this ‘Make in India’ product has found its way in the list of drugs for emergency care for stroke management in the guideline – ‘Prevention and Management of Stroke,’ issued by the Ministry of Health and Family Welfare, Govt. of India.

Gennova launched HAMSYL™ (Pegaspargase) in 2014 for use in acute lymphoblastic lymphoma (ALL), an orphan indication at the request of the Tata Memorial Hospital, Mumbai, India. This is an essential medicine not registered in India and outrageously priced, and was unaffordable to children with ALL. We launched it at one-third the price of the innovator, and our efforts have culminated in its inclusion under price control by National Pharmaceutical Pricing Authority (NPPA).

Gennova’s socio-economic responsibility has propelled it to establish itself it Global Health Initiative program, under which Gennova has established itself as a preferred research and cGMP manufacturing partner in the area of vaccine development to address some of the world’s most challenging diseases, particularly for the developing world like malaria, Leishmania, flu, etc. In this field, Gennova has national and international collaborations, e.g., University of Delhi South Campus (UDSC), PATH Malaria Vaccine Initiative (MVI), European Commission (under FP7 and Horizon 2020), Infectious Disease Research Institute (IDRI), National Institutes of Health (NIH), Johns Hopkins University (JHU), The London School of Hygiene & Tropical Medicine (LSHTM) and The Walter and Eliza Hall Institute (WEHI).

Recently, Gennova, in partnership with the US-FDA, McGill University, Ohio State University, Nekken Institute of Tropical Medicine, NIH, and JHU, has entered into a collaboration to develop and manufacture clinical-grade material of the genetically modified live attenuated Leishmania vaccine candidate, funded by the Global Health Innovative Technology Funds (GHIT), Japan. The program represents two important milestones for Gennova; having a collaborative vaccine program with the US-FDA is a significant testimony to Gennova’s capabilities and attributes and involves the formulation and manufacturing of a live attenuated vaccine to Gennova’s other vaccine programs, which focuses on recombinant-based products.

Gennova is currently working towards a therapeutic intervention and an mRNA-based vaccine against COVID-19. Gennova’s mRNA vaccine has already demonstrated safety, immunogenicity, neutralization antibody activity in the rodent and non-human primate models. Gennova has completed the clinical trials and awaiting regulatory approval.