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Gland Pharma, a generic injectable focused pharmaceutical company, said it is on track to begin production of Sputnik V COVID-19 vaccines from October-November.

Technology transfer of the drug substance to its manufacturing facility is under way, the company said. A dedicated manufacturing unit at Pashamylaram near Hyderabad is ready for commercial production.

Gland Pharma is investing Rs 300 crore on setting up dedicated manufacturing facilities to make COVID-19 vaccines. The company said it has invested about Rs 121 crore so far on vaccine manufacturing infrastructure. The company plans to repurpose a vaccine manufacturing facility later for contract manufacturing of biosimilars.

Gland Pharma entered into a partnership with Russia’s sovereign fund, the Russian Direct Investment Fund, in March to manufacture and supply up to 252 million doses of the Sputnik V vaccine. As per the agreement, Gland Pharma will supply the vaccines to RDIF at a fixed price till the end of next year.

Gland also signed an agreement to carry out the fill-finish of Hetero’s Sputnik V vaccine at its Pashamylaram site. Hetero has signed up with RDIF to produce 100 million doses of Sputnik V vaccines.

Fill-finish refers to processes including formulation, vial filling, testing, stability testing and release of licensed products.

Manufacturing challenges

Manufacturing the Sputnik V vaccine is complex because it uses two human adenoviral vectors – Ad26 and Ad5 for the first and second doses, respectively. The vaccine is administered in two doses 21 days apart. The Ad5 is used as a heterologous booster, which is critical to the efficacy of the vaccine. But manufacturers have complained about yield issues of the Ad5 vector.

“Ad26 gives a higher yield compared to that of Ad5, so to match up Ad26 output it (Ad5) requires more batches and reactors. They have changed the processes over time and the yields are improving. Hopefully they should resolve it,” Srinivas Sadu, MD & CEO of Gland Pharma, said on the company’s earnings call on July 21.

Sadu said he doesn’t expect demand for COVID-19 vaccines to ebb any time soon as the world would need 11 billion doses this year alone.

Click here for Gland’s Q1FY21 results


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