Technology experts from the Russian Direct Investment Fund (RDIF) recently visited Prestige Biopharma, a Korean contract manufacturing organization, to observe the pilot production of Sputnik Light, a Covid-19 vaccine developed in Russia.
Industry watchers are paying attention to whether the Korean consortium, consisting of Huons Global and other companies, including Prestige Biopharma, could start mass-producing the Russian vaccine from September.
On Monday, Prestige Biopharma said six technology experts, including RDIF technology advisor Dmitry Kulish, visited the company’s vaccine center in Osong, North Chungcheong Province.
The Russian officials will stay in Korea for about two months to wrap up the technology transfer of the Sputnik vaccine and prepare mass production with the Korean company, Prestige Biopharma said.
In September, technology experts from Prestige Biopharma plan to visit Russia.
Prestige Biopharma imported cell lines and viruses from Russia for pilot production of Sputnik Light in June.
Once the technology transfer is complete, Prestige Biopharma’s affiliated company Prestige Biologics will start manufacturing prototypes of the Russian vaccine with two 200-liter incubators at the first factory of Prestige Biologics.
From September, the company will start manufacturing Sputnik Light with a 2,000-liter incubator, Prestige Biopharma said.
“The recent visit by Russian officials is for technology transfer and pilot production,” an official at Prestige Biopharma said. “We aim to start production in earnest in September. If our schedule goes as planned, we will complete the technology transfer and pilot production this month.”
The Russian officials’ visit shed light on two Korean consortiums for the production of Russian Covid-19 vaccines.
One is led by Huons Global, the parent company of Huons, and the other, Hankook Korus.
The Huons Global consortium consists of Huons Global, Prestige Biopharma, Humedics, and Boran Pharma.
The Hankook Korus consortium consists of seven companies, including Hankook Korus, Jetema, Binex, Boryung Biopharma, ISU Abxis, CKD Bio, and Quratis, and the state-run Andong Animal Cell Culture Substantiation Center.
Huons Global said its consortium would be able to produce 20-30 million doses of Sputnik V or Light monthly until the end of this year, and over 100 million doses monthly from next year.
Huons secured the exclusive rights to the local approval and sale of Sputnik V and Sputnik Light. The company will seek domestic approval and emergency use approval for Sputnik Light simultaneously to win the nod as soon as possible, it said.
On April 29, Huons applied for preliminary review and submitted to the Ministry of Food and Drug Safety non-clinical data such as toxicity/efficacy test results.
“The technology transfer of Sputnik to the CMOs participating in the consortium is still ongoing,” an official at Huons said.
“We’re at the food and drug safety ministry’ preliminary review stage, and we haven’t applied for approval for Sputnik Light officially.”
When the government demands submission of data for Sputnik approval, the company will do so, he added.
The Korean government has not announced any plan to introduce the Sputnik V Covid-19 vaccine.
The vaccine obtained the nod in 61 countries, including Russia, except for the U.S. and Europe. The European Medicines Agency started a preliminary review on March 4, and the WHO has been reviewing the application for Emergency Use Listing (EUL) since October last year.