SK bioscience Expands Manufacturing Capacity to Enhance Global Vaccine Supply
Friday, May 30, 2025
SK bioscience has completed a significant expansion of its vaccine production site, L HOUSE, in Andong, South Korea.
The development is part of the company’s efforts to strengthen its global vaccine manufacturing infrastructure and support broader access to vaccines worldwide.
The expansion follows official building use approval from the City of Andong, confirming that the updated facility meets safety and operational standards. The upgrade involved adding two new floors to the existing vaccine production area, creating around 4,200㎡ of additional space. This investment supports the commercial-scale production of GBP410, a 21-valent pneumococcal conjugate vaccine (PCV) candidate co-developed with a global pharmaceutical partner.
SK bioscience is now preparing to obtain certification from the United States Food and Drug Administration (FDA) for current Good Manufacturing Practices (cGMP). The certification will help position L HOUSE as a key player in the global vaccine supply chain. The site had already achieved EU-GMP certification from the European Medicines Agency in 2021, becoming the first Korean vaccine facility to do so.
GBP410, the first PCV candidate with over 20 serotypes to reach Phase 3 trials in young children, began global clinical trials in December of the previous year. The studies are taking place across multiple countries, including Australia, the United States, and South Korea. The trials involve over 7,700 healthy participants between 6 weeks and 17 years of age and assess the vaccine’s immunogenicity and safety over multiple doses.
Previous Phase 2 data showed that GBP410 was comparable in safety and effectiveness to existing vaccines, such as Prevnar 13. If successful, GBP410 could play a key role in reducing invasive pneumococcal disease (IPD), a condition that continues to affect large numbers of young children. According to the World Health Organization, Streptococcus pneumoniae causes around 300,000 deaths annually among children under five, making it a leading cause of vaccine-preventable deaths.
In late 2024, SK bioscience and its partner expanded their collaboration to include the joint development of next-generation PCVs targeting both children and adults. The goal is to create broader-spectrum vaccines that build on the protection offered by current options, further reinforcing their pipeline of pneumococcal vaccines.
With advanced production capabilities and international regulatory experience, SK bioscience aims to contribute to public health efforts on a global scale while solidifying its role as a major vaccine supplier.
Source: skbioscience.com
