SK Bioscience has completed the expansion of its Andong L House vaccine plant, securing large-scale production capacity for its 21-valent pneumococcal conjugate vaccine (PCV).
The company announced on the 29th that it had received final occupancy approval from the city of Andong following the completion of the expansion project, which began in March last year.
With this, SK Bioscience has added production capacity for GBP410, a 21-valent pneumococcal vaccine candidate co-developed with global pharmaceutical company Sanofi. The expansion increased the existing vaccine production building from one floor to three, adding approximately 4,200 square meters of new space. The investment cost was jointly funded by both companies.
Following the completion, SK Bioscience plans to quickly proceed with equipment installation and pursue Current Good Manufacturing Practice (cGMP) certification, a prerequisite for entering the U.S. market. cGMP is among the strictest global manufacturing standards. L House had already proven its global competitiveness in 2021 by becoming the first domestic vaccine plant to receive EU-GMP certification from the European Medicines Agency (EMA).
GBP410 is currently undergoing Phase 3 clinical trials in Australia, the U.S., Korea, and other countries. The trial includes approximately 7,700 infants, children, and adolescents aged six weeks to 17 years. Participants will receive up to four doses of the vaccine, and the study will compare GBP410's immunogenicity and safety to those of existing pneumococcal vaccines. In Phase 2 trials, GBP410 demonstrated comparable immunogenicity and safety to control vaccines.
GBP410 is the first vaccine candidate in pediatric Phase 3 trials to cover more than 20 pneumococcal serotypes. It is expected to significantly reduce the incidence of invasive pneumococcal disease (IPD), a serious health issue among children. According to the World Health Organization (WHO), pneumonia causes about 700,000 deaths annually in children under five, with roughly 300,000 due to pneumococcal disease.
“This expansion further solidifies Andong L House’s status as a global vaccine hub with proven world-class production capabilities,” said Ahn Jae-yong, CEO of SK Bioscience. “We will contribute to global public health and position ourselves as Korea’s leading vaccine specialist through the successful development and supply of our pneumococcal vaccine.”
