March 8, 2024
The space will function as a manufacturing base for the next-generation pneumococcal conjugate vaccine candidate GBP410
SK bioscience has initiated a significant expansion of its vaccine manufacturing facility, L HOUSE, in Andong, Gyeongsangbuk-do, South Korea, to enhance its product pipeline.
The expansion involves adding two floors to the current vaccine manufacturing unit, resulting in 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.
This latest expansion will bolster SK bioscience’s manufacturing capabilities for global product supply.
The additional space will serve as a manufacturing base for the next-generation pneumococcal conjugate vaccine candidate GBP410, developed by SK bioscience in collaboration with Sanofi.
Both SK bioscience and Sanofi are investing in this expansion.
Recently, SK bioscience and Sanofi reported positive results from the Phase II clinical trials of GBP410, underscoring its potential as a blockbuster vaccine.
The trial enrolled infants to evaluate 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 expedite GBP410’s market introduction, SK bioscience plans to quickly 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.
Additionally, SK bioscience plans to enhance global competitiveness by establishing a cGMP-level manufacturing plant at Songdo’s research and product development center.
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.
CEO 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."