Gland Pharma teams up with RDIF to manufacture 252 mn doses of Russia's Sputnik V COVID vaccine

Under the terms of the agreement, Gland Pharma said it will first undertake technology transfer of the drug substance to its manufacturing facilities. After successful technology transfer, Gland Pharma will then undertake manufacturing of drug substance and drug product filling into vials under aseptic conditions.

Viswanath Pilla
March 16, 2021 / 06:33 PM IST

(Image: Reuters)

 
 
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Drug maker Gland Pharma announced on Tuesday that it has entered a partnership with Russian Direct Investment Fund (RDIF) to manufacture and supply up to 252 million doses of Russia's Sputnik V coronavirus vaccine. The production will begin in the fourth quarter of 2021.

"Gland Pharma will be leveraging its manufacturing capabilities for the production of Sputnik V COVID-19 vaccine. The agreement will see Gland Pharma utilising its Drug Substance and Drug Product facilities at its sites in Hyderabad. The production is expected to commence from third quarter of 2021 for estimated delivery starting from fourth quarter of 2021," said Gland Pharma said in a statement.

Under the terms of the agreement, Gland Pharma said it will first undertake technology transfer of the drug substance to its manufacturing facilities. After successful technology transfer, Gland Pharma will then undertake manufacturing of drug substance and drug product filling into vials under aseptic conditions.

The Hyderabad-based injectable drug maker owned by China's Fosun Pharma said that its expertise in manufacturing sterile injectable at significant scale will support the stable supply of the vaccine.

The COVID-19 vaccine Sputnik V has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology. It became the world's first registered COVID-19 vaccine based on the human adenoviral vector platform.

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Dr Reddy'sLaboratories has also partnered with RDIF to do local clinical trials and manufacture of 125 patient doses of the Sputnik V vaccine. The company also sought emergency use authorisation approval last month. The drug regulator, however, asked the company to provide immunogenicity data. India's Hetero has also entered into a deal with RDIF to manufacture 100 million doses of the vaccine.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
TAGS: #Business #Companies #coronavirus #Health
first published: Mar 16, 2021 06:33 pm