The new plant, construction of which began yesterday, will be run by CPL Biologicals (CPLB), Novavax’s joint venture (JV) with India’s largest privately-held drugmaker company Cadila Pharmaceuticals.
When operational in February, the 25,000 sqft facility will have capacity to make up to 60m doses of influenza vaccine a year using Novavax’s virus-like particle (VLP) manufacturing technology.
The virus-like particle (VLP) cell-culture technology, which mimics the structure of a wild type virus to elicit an immune response but is unable to replicate, cuts production time to a fraction of that required using traditional egg-based manufacturing methods.
In time, the manufacturing facility will also make vaccines for other indications being developed by CPLB, using the VLP platform.
A Novavax spokesperson told in-PharmaTechnologist that: "Our Indian JV... is important in many ways to Novavax. It is the realization of our regional strategy to provide in-border manufacturing capacity of influenza and other VLP vaccines."
She declined to comment on potential revenue generated by the project but added that: "suffice to say that we are firm believers in the value our CPLB joint venture and this new facility."
In a press statement, John Trizzino, senior VP of Novavax’ international and global alliances, who will also serve as interim CEO of the JV, explained that Cadila is providing 100 per cent of the financial support for the plant.
“We anticipate creating capacity for CPL Biologicals to sell influenza vaccines in India and at the same time become a potential supplier to Novavax for sale of vaccines in other markets where Novavax maintains commercial rights.”
VLP technology
Trizzino went on to say that the partnership model, coupled with the short time in which the plant will be made fully operational, demonstrates the efficiency and scalability of the VLP platform and the role it can play in address demand for influenza vaccine.
“Moreover the construction of this… facility is consistent with Novavax’ strategy to establish regional partnerships with…. manufacturing capabilities that allow our VLP influenza vaccines to be licensed, manufacturing and sold throughout the world.”
Novavax showcased the capability of its VLP technology with the opening of its first vaccine manufacturing plant in the US in May last year.
The 5,000 sq ft, $5m facility, in Rockville, Maryland, served as both a pilot plant for manufacture and as a promotional platform for the technology and for Novavax’ partnering plan. Recent events suggest that the approach is paying off.
In July for example, Novavax’s technology was selected by the Spanish government for the country’s first vaccine manufacturing facility in a collaboration between the Ministry of Health and Novavax licensee Rovi Pharmaceuticals.
In addition to Ravi and Cadila, Novavax also works with GE Healthcare on implementation of the VLP technology and is likely to sign other agreement as concerns about the lack of H1N1 vaccine continue to grow.