[Photo provided by SK Bioscience]
Shares rallied Monday after South Korea’s SK Bioscience’s Andong base responsible for producing Covid-19 vaccines of AstraZeneca and Novavax earned Good Manufacturing Practices (GMP) certification from the European Union authority, making outputs from the facility eligible for shipments across Europe.
The Korean company said Monday its production facility and process and quality systems to manufacture the coronavirus jabs at its vaccine plant, L House, in Andong, Gyeongbuk Province won EU-GMP certification, which requires strict management standards for all processes from purchasing of raw materials to manufacturing, quality control, and shipment to ensure safe and effective pharmaceuticals.
Shares of SK Bioscience finished 9.3 percent up at 159,500 won ($140.5)
SK Bioscience passed on-site inspections and document reviews conducted by the EMA for about a month. A final certification was granted on Mar. 29 as a CMO for AZ’s Covid-19 vaccine and on Apr. 26 as a CDMO for Novavax.
Upon the certification, SK Bioscience’s vaccine output can be shipped to EU member countries. The company said it will apply for the FDA’s cGMP certification for U.S. export, while expanding cooperation with multinational companies in need of CMO and CDMO for various vaccines by expanding output from L House.
L House is equipped with technology and trained workers for mass production of various vaccines.
SK Bioscience has rolled out AZ’s Covid-19 vaccines since its contract to produce vaccine substances and products in July last year.
The company signed a CDMO deal with Novavax in August last year and introduced vaccine technology from the U.S. biotech firm in February.
By Minu Kim
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