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‘It has been a tough journey, trying to ramp up production’, says CEO of firm that made India’s first mRNA Covid vaccine

The Drug Controller General of India recently approved phase 2/3 study protocols of HGCO19, developed by Gennova Biopharmaceuticals Limited, a subsidiary of Pune-based Emcure Pharmaceuticals Limited.

Written by Anuradha Mascarenhas | Pune |
Updated: August 27, 2021 7:17:50 am
pune, Gennova Pharmaceuticals, mRNA vaccine, pune news, covid-19, covid vaccine, indian express, indian express newsDr Sanjay Singh, CEO of Gennova Pharmaceuticals. (Express Photo)

Since the central government has set a production target of 60 million doses for the country’s first mRNA Covid-19 vaccine by the end of the year, Dr Sanjay Singh, CEO of Gennova Pharmaceuticals, said production is being ramped up.

“It has been a tough journey but this is a new platform and we have to innovate to find solutions. We are trying to put our best foot forward and ramp up production,” Singh told The Indian Express on Thursday.

He delivered a special address on ‘Innovate and Society’ as part of the 33rd foundation day celebrations of the National Centre for Cell Science (NCCS). Gennova Pharmaceuticals has developed India’s first mRNA Covid-19 vaccine.

The Drug Controller General of India recently approved phase 2/3 study protocols of HGCO19, developed by Gennova Biopharmaceuticals Limited, a subsidiary of Pune-based Emcure Pharmaceuticals Limited.

“The Department of Biotechnology of the Indian government has made a core investment with seed money of Rs 25 crore and Rs 100 crore for the phase 2/3 trial process that will commence soon,” Singh said.

Despite a high level of interest in the mRNA platform for Covid-19 vaccines, the firm had to face several challenges in terms of undertaking multiple toxicology tests and even making their own enzymes.

Singh said that they managed to innovate in terms of temperature control for the mRNA vaccine. This ruled out operationalising freezing temperatures for storage and distribution.

“Our own messenger RNA (mRNA)-based vaccine against Covid-19 can be stored at two to eight degrees Celsius, unlike our peers working on mRNA vaccine platforms, which need ultra-storage technology,” Singh said.

This is the first vaccine on this platform that has shown stability at temperatures between 2-8 degrees Celsius, he added.

An mRNA platform is important as it is easier to manufacture for a country like India. “But since this is a new platform for India, we had to go through two independent toxicology studies as required by regulatory authorities. This can be a tough challenge for a small company like Gennova,” Singh said.

“Also, if somebody has to grow the virus, then one needs a biosafety level 3 laboratory. For the mRNA vaccine, one does not require this facility as the technology is an advanced one. But since these are new technologies, several questions have to be answered,” he said.

Singh also said they would prefer to proceed step-by-step and roll out the vaccine first for adults. “We are aiming at two doses of the mRNA vaccine and till we have more safety data, we will go step-by-step.”

Dr Renu Swarup, secretary, DBT, Government of India, who also spoke at the programme, said the mRNA vaccine was an important milestone in fight against Covid-19 . She said that expectations from the scientific community have risen manifold.

“The country is geared to provide affordable and acceptable technology to the masses. However, now is the time for scientists who have so much potential to look at an exponential growth phase,” Swarup said.

She said that expectations have risen enormously and pointed to the challenges faced during the scaling of Covaxin vaccine development as access to vero cell lines was a limitation. “Expectations have increased manifold and we look at NCCS coming up with cutting edge technologies in cell sciences and gene therapies…research in microbial cell sciences is also moving to a new level,” Swarup said.

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