The first South Korean vaccine manufacturing facility to achieve EU-GMP certification from the European Medicines Agency (EMA) is being expanded to support global supply of a pneumococcal conjugate vaccine.
Overall, the goal of expanded facility is to strengthen [SK biosciences] manufacturing capabilities for global supply [of the pneumococcal conjugate vaccine candidate GBP410]”
SK bioscience has announced its manufacturing plant L HOUSE, in Andong, Gyeongsangbuk-do, South Korea, is set to have a facility expansion. The new space will be provide a production base for the next-generation pneumococcal conjugate vaccine candidate GBP410 (SP0202), jointly developed by SK bioscience and Sanofi.
Overall, the goal of expanded facility is to strengthen its manufacturing capabilities for global supply, SK bioscience stated. Two floors will be added to the facility’s existing vaccine manufacturing department. This will generate approximately 4,200m2 of new space, SK bioscience explained. The firm shared that following the facility expansion, it plans to obtain current good manufacturing practice (cGMP) certification for the new facility.
Promise of the pneumococcal conjugate vaccine
SK bioscience and Sanofi announced positive results from the Phase II clinical trials of the GBP410 vaccine in infants, in June 2023. The data from the studies suggested that the vaccine has “blockbuster potential”, according to SK bioscience. A global Phase III clinical trial is being planned, with an expected regulatory submission in 2027.
Prior to this new facility expansion, SK bioscience highlighted that in 2021, L HOUSE was the first domestic vaccine manufacturing facility to achieve EU-GMP certification from the European Medicines Agency (EMA).
Harnessing market potential following the facility expansion
The pneumococcal vaccine market is predicted to value $10.3 billion by 2028, based on data from Evaluate Pharma.
[The] expanded manufacturing facility [is planned to support] introduction of the pneumococcal conjugate vaccine into the worldwide market”
SK bioscience shared that together with Sanofi, the company plans to take advantage of the expanded manufacturing facility to advance the successful introduction of the pneumococcal conjugate vaccine into the worldwide market, including US, Europe, and South Korea.
Following the facility expansion, L HOUSE will “firmly establish itself as a global vaccine hub… We will make every effort to achieve successful development and supply of a vaccine with blockbuster potential,” Jaeyong Ahn, CEO of SK bioscience shared.
According to the World Health Organization (WHO) around one million children are infected with Streptococcus pneumoniae (the pneumococcus) every year, SK bioscience noted.
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