SK Bioscience vaccine plant gets EU approval

SK Bioscience's plant in Andong, North Gyeongsang Province / Courtesy of SK Bioscience

By Kim Bo-eun

SK's vaccine contract manufacturer said Monday that it received quality approval from European authorities for its plant that produces COVID-19 vaccines here.

Its Andong plant in North Gyeongsang Province is manufacturㅑㅜㅎ COVID-19 vaccines for U.K. company AstraZeneca on a contract basis, and it plans to do so for U.S. firm Novavax, once drug authorities approve the vaccine.

SK Bioscience said that the European Medicines Agency determined its Andong plant met its good manufacturing practice (GMP) standards. GMP is the minimum standard Europe requires medicine manufacturers to meet in their production processes.

The biopharmaceutical company received the European authority's approval in the contract manufacturing of AstraZeneca's COVID-19 vaccine on March 29. It also obtained approval for manufacturing the Novavax COVID-19 vaccine candidate on April 26. This case is the first where a local vaccine plant has been certified by European standards. SK Bioscience is seeking to receive the same approval from the U.S. Food & Drug Administration (USFDA).

The vaccine manufacturer plans to expand its Andong production plant to boost production capacity, as it aims to win more orders to develop and produce the vaccines of global firms.

SK Bioscience said its advanced technology-based manufacturing facilities and R&D personnel are optimized to produce vaccines and the processes involved in making them, such as cell cultivation, bacterial cultivation, gene recombination and protein conjugation. The company said that these optimized capabilities enable it to mass-produce even the newest vaccines immediately. It is also reviewing the extension of existing contracts, as client firms are seeking to increase their vaccine supplies.

"With the pandemic, the global vaccine demand is expected to increase explosively, and SK Bioscience is at the center of it," SK Bioscience CEO Ahn Jae-young was quoted as saying in a press release. "Based on our globally recognized technologies, we will accelerate our business expansion.”

SK Bioscience signed a contract to manufacture the drug substance and final product of the COVID-19 vaccine developed by AstraZeneca and Oxford University in July of last year. The company then sealed a deal with Novavax to develop and produce its COVID-19 vaccine in August 2020. The SK affiliate also signed a license contract with Novavax, earning the rights to produce and sell its COVID-19 vaccine candidate in Korea.

Novavax CEO Stanley Erck visited SK Bioscience's Andong plant last month, to check its vaccine production and to discuss related issues with the contract manufacturer. Erck also met with President Moon Jae-in to discuss the vaccine supply. Novavax's vaccine has yet to receive approval globally.