SK bioscience to expand vaccine manufacturing plant in South Korea
08 Mar 2024
VaccinePhase 2Clinical ResultPhase 3
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Source: Pharmaceutical Technology
SK bioscience CEO Jaeyong Ahn (fourth from left), Sanofi Korea Vaccines general manager and representative director Pascal Robin (fifth from left) and other distinguished guests at the ground-breaking ceremony for L HOUSE. Credit: SK bioscience.
SK bioscience has broken ground on a significant expansion of its vaccine manufacturing facility, L HOUSE in Andong, Gyeongsangbuk-do, South Korea, to enhance its product pipeline.
The expansion includes the addition of two floors to the current vaccine manufacturing unit, creating 4,200m² of new space.
The ground-breaking ceremony was attended by Gyeongsangbuk-do Governor Cheol-woo Lee, Andong City Mayor GiChang Kwon, Sanofi Korea Vaccines general manager and representative director Pascal Robin, and SK bioscience CEO Jaeyong Ahn.
The latest expansion plans boost SK bioscience’s manufacturing expertise for product supply across the globe.
The space will function as a manufacturing base for the next-generation pneumococcal conjugate vaccine candidate GBP410, developed by SK bioscience in collaboration with Sanofi.
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Both parties are investing in the unit’s expansion.
SK bioscience and Sanofi recently reported positive data from the Phase II clinical trials of GBP410, indicating its potential as a blockbuster vaccine.
The trial enrolled infants to assess the vaccine’s safety and immunogenicity.
The companies are now preparing for an international Phase III trial with an anticipated regulatory submission in 2027.
To ensure the rapid introduction of GBP410 into the worldwide market, SK bioscience plans to swiftly obtain current good manufacturing practice (cGMP) certification for the new facility.
L HOUSE received EU-GMP certification from the European Medicines Agency in 2021, making it the first domestic vaccine production unit to achieve this milestone.
Sanofi and SK bioscience aim to leverage the expanded manufacturing space to fast-track GBP410’s launch in key markets such as Europe, the US and South Korea.
SK bioscience also plans to enhance global competitiveness by establishing a cGMP-level manufacturing plant at Songdo’s research and product development centre.
This facility will act as a pilot plant for small-scale tests, crucial for collaborations with global partners and the introduction of new processes or products.
Ahn stated: “L HOUSE, which demonstrates global competitiveness in manufacturing capabilities, will firmly establish itself as a global vaccine hub through this expansion.
“We will make every effort to achieve successful development and supply of a vaccine with blockbuster potential.”
Last month, SK bioscience received prequalification (PQ) certification from the World Health Organization (WHO) for its typhoid conjugate vaccine, SKYTyphoid.
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