CDMO's site becomes the first vaccine production facility in South Korea to obtain EU GMP certification, allowing it to ship to Europe

South Korean CDMO SK Bioscience, which is manufacturing COVID-9 vaccines for both AstraZeneca and Novavax has received European Union Good Manufacturing Practice (EU GMP) certification for its Andong L House site.

The European Medicines Agency (EMA) certification, which approves the production facilities, processes, and quality systems for both AstraZeneca and Novavax COVID-19 vaccines being manufactured there, allows the CDMO to export vaccines to Europe.

The company said it is now making preparations to gain cGMP certification from the US Food and Drug Administration. Once it has successfully met that objective, SK Bioscience said it then plans to expand L House to accommodate growing demand by global companies for contract manufacturing services.

L House’s manufacturing facilities and R&D personnel are geared up for vaccine production, including activities such as cell cultivation, bacterial cultivation, gene recombination, and protein conjugation, so that even the newest vaccines can immediately enter mass production.

Last July, SK Bioscience agreed to manufacture the drug substance and the final product of the COVID-19 vaccine developed by AstraZeneca and Oxford University in the UK. This followed a Letter of Intent signed between SK Bioscience, AstraZeneca and South Korea's Ministry of Health and Welfare to accelerate vaccine manufacturing to help stem the pandemic in Korea and abroad.

In August last year, the company signed a CDMO contract to develop and produce Novavax’s COVID-19 vaccine. Earlier this year (February), SK Bioscience secured the rights to produce and sell Novavax's COVID-19 vaccine candidate, NVX-CoV2373, in South Korea.

SK Bioscience CEO Ahn Jae-yong said “the global vaccine demand is expected to increase explosively” and “we will accelerate our business expansion”.