The certification approves the production and processing line and quality system of SK bioscience’s Andong plant, which produces COVID-19 vaccines developed by AstraZeneca Plc and Novavax Inc
South Korea’s SK bioscience has said that its COVID-19 vaccine facility had received European Union Good Manufacturing Practices (GMP) certification, paving the way for exports to the bloc.
The certification approves the production and processing line and quality system of SK bioscience’s Andong plant, which produces COVID-19 vaccines developed by AstraZeneca Plc and Novavax Inc. It will enable SK to export vaccines to the European markets.
SK bioscience is also looking to obtain the Current Good Manufacturing Practice (CGMP) regulations enforced by the US Food and Drug Administration (FDA), it said in a statement.
It has been supplying the AstraZeneca vaccine it has produced to the domestic market and the global vaccine sharing facility COVAX.
SK bioscience also has a license agreement with Novavax to produce 40 million COVID-19 vaccine doses for South Korea as well as a contract development and manufacturing deal for global supply.
“The global vaccine demand is expected to surge explosively driven by the pandemic … Based on the globally recognised high-level technology, we will accelerate our business expansion,” Ahn Jae-yong, CEO, SK bioscience, said in a statement.