Moscow: South Korea’s SK bioscience has obtained the European Goof Manufacturing Practice (GMP) certification which could open path for the export of COVID-19 vaccines to the EU.
“SK bioscience, which has become a global hub for COVID-19 vaccine production, has obtained an international certification recognizing its excellent vaccine production capabilities,” the company said in a statement.
This is the first time that a South Korean vaccine production process has acquired EU-GMP status.
SK bioscience gained access to final certification for the production of AstraZeneca vaccines on March 29 and for Novavax vaccine candidate’s manufacturing facilities on April 26.
The certification will allow South Korean factory made vaccines to enter the EU market and the country is currently planning to prepare for the current Good Manufacturing Practice (cGMP) certification, which needs approval by the United States Food and Drug Administration (FDA).
“With the pandemic, the global vaccine demand is expected to increase explosively, and SK bioscience is at the center of it … Based on our globally recognized technologies, we will accelerate our business expansion,” SK bioscience CEO Ahn Jae-yong said.
In July last year a CMO contract was signed by SK bioscience which allowed the company to manufacture the drug substance and the final product of the AstraZeneca COVID-19 vaccines. In August last year a CDMO contract was signed which allows SK bioscience to develop and produce Novavax’s vaccine.
The GMP is a certification system which applies strict management standards to all steps of manufacturing of pharmaceutical products. EU-GMP is one of the world’s leading certification systems alongside the cGMP from the US.
SK bioscience is currently in the process of reviewing more contracts and extensions, as well as developing the production schedule of its own COVID-19 vaccine.’