SK Bioscience Receives EU-GMP Certification for COVID-19 Vaccine Production Plant, Making it Korea’s First

Image Courtesy: SK Bioscience

South Korea is a huge player in global vaccine production. The country has signed CMO and CDMO deals with some of the top companies that are in the COVID-19 vaccine race.

Korea’s First EU-GMP for COVID-19 Vaccine Production Plant

On May 17th, Korea’s SK bioscience received the country’s first EU-good manufacturing practice (GMP) certification from the European Medicines Agency (EMA) for COVID-19 vaccine manufacturing.

The approved production plant is located at the Andong Plant L House and is used for producing Novavax’s NVX-CoV2373 and AstraZeneca’s AZD1222. The EU-GMP will provide SK bioscience access to exporting vaccines to the EU market, expanding the possible CMO and CDMO deals.

SK bioscience said that L House consists of advanced technology-based manufacturing facilities and R&D personnel optimized to carry out 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.

Preparation for cGMP Approval

After obtaining EMA’s nod, SK bioscience next aims for the current good manufacturing practices (cGMP) certificate from the USFDA and is currently preparing for approval.

“With the pandemic, the global vaccine demand is expected to increase explosively, and SK bioscience is at the center of it,” said Ahn Jae-Yong, CEO of SK bioscience. “Based on our globally recognized technologies, we will accelerate our business expansion.”

Related Article: Korea’s SK Group Acquires 70% Equity in French Gene Therapy CDMO

Author

Tyler Chen

"Never go to a doctor whose office plants have died."- Erma Bombeck