Stellis Biopharma gets CDSCO approval to manufacture and export Sputnik Light 

Strides Pharma Science Limited’s biotech division Stelis Biopharma has commissioned its large-scale, greenfield vaccine manufacturing facility at Bengaluru for producing and supplying 50 million doses of the Russian COVID-19 vaccine — Sputnik Light. The approval was granted after a successful inspection of the facility by the Central Drugs Standard Control Organisation (CDSCO). The biotech firm has also received an initial Export No-Objection Certificate (NOC) to export ~50 million doses of the Sputnik Light vaccine, according to an exchange filing.

Stelis has begun manufacturing the Sputnik Light vaccine at a commercial scale and is on track to commercialise the vaccine for global markets in Q4FY22. The biotech firm joined hands with Russia’s sovereign wealth fund —Russian Direct Investment Fund (RDIF) to produce and supply the vaccine. Besides this, the site can offer technologies to produce lentivirus, adenovirus and retrovirus products/vaccines with adherent and suspension-based processes.

The filing also states that the Stelis facility is one of the largest viral vector manufacturing sites to produce the Russian vaccine and is equipped with 40,000 litre drug substance bioreactor capacity at a 2,000 litre scale using single-use bioreactor technology, providing optimum flexibility and cost-effectiveness for any volume demand. Drug product block of the facility to produce ~720 million doses annually.

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