A consortium led by GL Rapha to produce Sputnik V, Russia's Covid-19 vaccine, is nearing its composition.

GL Rapha-led Sputnik V CMO consortium has added new member Jetema to begin producing the Russian vaccines soon.
GL Rapha-led Sputnik V CMO consortium has added new member Jetema to begin producing the Russian vaccines soon.

Following ISU Abxis and Hankook Korus Pharm, Jetema has received technology transfer to finish preparations for manufacture as a member of the consortium.

As GL Rapha has announced that it could start production in Korea as soon as Russia's Ministry of Health and Social Development approves the companies’ good manufacturing practice (GMP), attention is drawn to whether Korean companies will play the role of a production base for Russia's Covid-19 vaccine.

Jetema said Wednesday it had signed a third-party technology transfer contract concerning the production of the Sputnik V vaccine's undiluted solution with Human Vaccine LCC, a subsidiary of Russian Direct Investment Fund (RDIF), and GL Rapha responsible for Sputnik V production in Korea.

Jetema’s contract signing has increased the number of companies that concluded a technology transfer agreement to produce Sputnik V undiluted solution in the GL Rapha-led Sputnik V contract manufacturing organization (CMO) consortium to three, including GL Rapha's subsidiaries, Hankook Korus Pharm, and ISU Abxis.

Jetema said it had decided to advance to the CMO business of undiluted Covid-19 vaccine in May and conducted working-group discussions with Hankook Korus Pharm for technology transfer since June.

Under the contract, Jetema will cultivate and refine the adenovirus of Sputnik V vaccines. The company emphasized that it can produce the vaccine based on its existing botulinum toxin strain culture and purification technology.

The company also said that the 10 billion won ($8.7 million) investment into new plant and equipment, unveiled in its public notice on May 7, was also for the company’s participation in the CMO consortium.

"The main purpose of the manufacturing capacity expansion through the investment is to produce the vaccine stock solution," a company official said. “However, as the company has yet to reach the stage of starting the production of the E-type botulinum toxin strain as originally announced, it will decide later whether to expand capacity additionally through a review later.”

Jetema also said it had introduced a 1,000-liter bioreactor in a separate space within its plant in Wonju, Gangwon Province, and plans to complete a 5,000-L production facility early next year.

GL Rapha said that Jetema's participation in Sputnik V CMO would help accelerate the production of Sputnik V.

"It is true that Jetema is a new member of our Sputnik V consortium, and we continue to cooperate with existing consortium participants such as Binex," a GL Rapha official told Korea Biomedical Review. "Among the companies participating in the consortium, there was only one change – the exit of Humedix."

GL Rapha is awaiting GMP approval from the Russian health authorities as the main production is possible only after Hankook Korus Pharm's plant wins the go-ahead.

"The main production schedule of the Sputnik V consortium hangs on the GMP approval," the company official said. "Since RDIF and GL Rapha first signed a CMO contract, and the rest of the consortium participating companies signed a subcontract with GL Rapha, we believe that there is no need for separate permission."

The company has submitted the documents required for GMP approval and expects to receive the GMP approval in August, he added.

Copyright © KBR Unauthorized reproduction, redistribution prohibited