COVID-19 vaccine (Representative image)
Emcure, the parent company of Gennova Biopharmaceuticals that's developing messenger RNA (mRNA) COVID-19 vaccine, said it is working on backward integration of its jab to reduce dependence on key imported raw materials, reagents and enzymes that go into the manufacturing.
"A lot of these key starting materials that go into the mRNA vaccine - Modernas and Pfizers of the world - rely on a lot of European and US suppliers. We saw that as a potential bottleneck," Vikas Thapar, President, Corporate Development & Strategy at Emcure, told Moneycontrol.
"Gennova is trying to do backward integration, solve some of these key raw materials, reagents and enzymes that go into the manufacturing. We believe that by the time we are in a position to scale up, we hopefully would have addressed a lot of critical issues," Thapar said.
He expressed concern about export restrictions by the US, the key source of vaccine raw materials, especially mRNA vaccines. The US has invoked the US Defence Production Act to preserve vaccine raw materials for its own companies.
"I mean, those types of restrictions continue to be a worry, like key components that go into manufacturing, raw materials," Thapar said.
Gennova, which is developing a potential indigenous mRNA COVID-19 vaccine called HGCO19, has initiated the enrolment of volunteers for Phase I and II clinical trials for its mRNA vaccine candidate. The vaccine has successfully completed animal trials and the clinical trials are expected to be completed in the next two-three months.
The biotech company from Pune has collaborated with Seattle-based HDT Biotech Corporation, which will supply adjuvant that boosts the efficacy of the vaccine.
"The Phase I clinical trial should begin anytime soon. The animal toxicity and safety studies that we conducted as part of preclinical studies have produced desired results," Thapar said.
Gennova has received seed funding from the Department of Biotechnology.
Emcure is working on ways and means to set up manufacturing capacities for its mRNA vaccine. According to Crisil Ratings, Gennova, which has planned a capex of Rs 250 crore for facility expansion, is expected to be funded by a Rs 70-crore government grant and Rs 135 crore debt, while the remaining will come from internal accrual.
Thapar, the son-in-law of Satish Mehta, Founder and Chairman of Emcure, one of India’s largest privately held pharmaceutical companies, explained how building an indigenous mRNA vaccine comes with its own set of challenges.
"The execution or what happens behind the scene is so critical. Being able to source the equipment (is a major challenge). In some cases, the smallest of the equipment can run down an entire operation. We source equipment from all over the world. That is something we are trying to address as best as we can,” Thapar said.
According to him, they had ``been lucky that a lot of the equipment was already there, and we are able to repurpose it. In some cases- the equipment arrives - the installation and validation are a challenge; we also use outside consultants for a variety of tasks. Because of the pandemic, in some cases we are doing validations remotely over onsite.”
Thapar pointed out that they had the ``inhouse expertise to tackle these challenges."
The President, Corporate Development and Strategy at Emcure, said that Gennova is open to working with partners on augmenting capacity of its own COVID-19 vaccine and of others.
"We are focusing on our own mRNA vaccine. The fill and finish of mRNA vaccine is done at Emcure's sterile manufacturing facility. If we get a go ahead (approval from regulator) for our mRNA vaccine...we could augment capacity by offering somebody else handling our own product in India and other markets," Thapar said.
He said that in ``many markets outside India, the tie-ups would more probably be in terms of licensing our products to others, not so much on the manufacturing," adding that ``if the company has spare installed capacity it may evaluate the option of producing other COVID-19 vaccines.”
Thapar says that work on the mRNA vaccine at Gennova had begun as soon as the COVID-19 pandemic struck the world.
"mRNA is a platform that has existed over the last one decade. There are other global companies working on the mRNA platform. Dr Sanjay Singh (CEO of Gennova Biopharmaceuticals) along with his team, were able to quickly see if we could apply this technology towards developing a COVID-19 vaccine,” he explained.
Singh, with three decades of experience in vaccines and biopharmaceuticals, has been roped by Emcure to set up the biotech subsidiary.
Prior to starting Gennova in 2006, he worked as a Head of Antigen Development Section of Malaria Vaccine Development Branch at the National Institute of Health, USA.