SK Bioscience Novavax Vaccine Manufacturing Facility Obtains EU-GMP Certification

SK Bioscience's 'L House Vaccine Center' in Andong-si, Gyeongbuk (Photo by SK Bioscience)

[Asia Economy Reporter Lee Chun-hee] SK Bioscience's Novavax vaccine manufacturing facility has confirmed its global-level vaccine production capabilities by receiving GMP (Good Manufacturing Practice) certification from the European Medicines Agency (EMA).

On the 25th, SK Bioscience announced that the Novavax COVID-19 vaccine production facility, processes, and quality systems operating at L House in Andong-si, Gyeongbuk Province, have additionally obtained EU-GMP certification approved by the EMA. SK Bioscience has a CDMO (Contract Development and Manufacturing Organization) contract for the Novavax vaccine and has been producing the vaccine under this agreement. Currently, SK Bioscience is the only domestic company responsible for the entire production process of the COVID-19 vaccine, from the bulk substance to the finished product.

This is the third time SK Bioscience's L House contract manufacturing (CMO) facility has obtained EU-GMP certification. Last year, SK Bioscience acquired EU-GMP certification for one AstraZeneca COVID-19 vaccine manufacturing facility and one of three Novavax COVID-19 vaccine manufacturing facilities. Following the recent approval of one additional Novavax vaccine manufacturing facility, SK Bioscience is also pursuing EU-GMP certification for the remaining facility. EMA on-site inspection is expected to take place as early as the first quarter.

Since November last year, SK Bioscience passed the EMA’s approximately two-month-long on-site inspection and document review process, obtaining this third EU-GMP certification. Based on its world-class capabilities with EU-GMP certification for three COVID-19 vaccine manufacturing facilities, SK Bioscience plans to accelerate the supply of Novavax COVID-19 vaccines.

Novavax COVID-19 vaccine 'Nuvaxovid Prefilled Syringe' is being produced at the L House factory of Andong SK Bioscience. (Photo by SK Bioscience)

SK Bioscience is the first domestic vaccine manufacturing facility to receive EU-GMP certification. EU-GMP certifies the entire vaccine production process, from raw material procurement to manufacturing, quality control, and shipment, based on strict standards. Alongside the U.S. Food and Drug Administration (FDA)’s cGMP, it is considered one of the highest-level certifications worldwide. A SK Bioscience official explained, "We are also preparing for cGMP certification," adding, "Since the Novavax vaccine is actively being approved in Europe, we prioritized obtaining EU-GMP first."

Recently, Novavax has received COVID-19 vaccine usage approvals from the EMA, the World Health Organization (WHO), India, Indonesia, the Philippines, France, Australia, and others. Domestically, on the 12th, the Ministry of Food and Drug Safety approved the product license for SK Bioscience’s CMO-produced Novavax vaccine 'Nuvaxovid Prefilled Syringe.' The government has signed a supply contract for 40 million doses of the Novavax vaccine.

SK Bioscience plans to further expand its CMO business with global vaccine companies based on the vaccine manufacturing and quality control capabilities proven through EU-GMP certification.

Jae-yong Ahn, CEO of SK Bioscience, said, “By consecutively securing the world’s most stringent certifications for the L House production facilities, we are being recognized for our global-level capabilities,” and added, “Based on our verified vaccine production and quality control abilities, we will continue to collaborate with global companies to expand our CMO business.”

This content was produced with the assistance of AI translation services.