INCHEON, South Korea & ROCKVILLE, Maryland, USA — March 31, 2026
Samsung Biologics has officially completed the acquisition of a cGMP biologics manufacturing facility from GSK, marking a major milestone in its global expansion strategy and contract development and manufacturing (CDMO) capabilities. The acquisition establishes Samsung Biologics’ first manufacturing footprint in the United States, significantly strengthening its position as a global leader in biopharmaceutical manufacturing and supply chain innovation.
Strategic Expansion Strengthens Global Manufacturing Network
The acquired Rockville facility includes two cGMP-compliant manufacturing plants with a combined capacity of 60,000 liters of drug substance production, increasing Samsung Biologics’ total global manufacturing capacity to 845,000 liters. This expansion enhances the company’s ability to support both clinical and commercial-scale biologics manufacturing, enabling greater flexibility in meeting the needs of global biopharma clients.
By establishing a U.S.-based production hub, Samsung Biologics significantly improves its geographical diversification, allowing closer proximity to key pharmaceutical markets and clients. This move aligns with the growing industry emphasis on regionalized manufacturing and supply chain resilience, particularly in response to increasing global demand for biologics and advanced therapeutics.
cGMP Facility Enhances Biologics Production Capabilities
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The Rockville site is fully equipped with current Good Manufacturing Practice (cGMP) infrastructure, supporting high-quality production standards required for regulated biologic therapies. The facility is capable of manufacturing across multiple scales, ensuring seamless transition from early-stage clinical development to large-scale commercial production.
Samsung Biologics will continue to supply products previously manufactured at the site to GSK, ensuring operational continuity and regulatory compliance during the transition period. In addition, the company plans to expand the site’s capabilities through further investments in advanced technologies and capacity upgrades, reinforcing its long-term commitment to quality-driven manufacturing excellence and innovation.
The integration of more than 500 experienced employees from the Rockville site further strengthens Samsung Biologics’ operational expertise, enhancing its ability to deliver high-quality, scalable manufacturing solutions to global partners.
Advancing CDMO Leadership and Patient Access
This acquisition represents a critical step in Samsung Biologics’ strategy to expand its CDMO leadership by offering end-to-end services across drug development, manufacturing, and commercialization support. The addition of a U.S. facility enables the company to provide localized manufacturing solutions, improving responsiveness to client needs and accelerating timelines for drug production and delivery.
From a cGxP and regulatory perspective, the expansion highlights the importance of compliance, quality systems integration, and global regulatory alignment in maintaining consistent standards across manufacturing sites. The Rockville facility will play a key role in supporting the production of life-saving biologics, contributing to improved patient access and healthcare outcomes worldwide.
Industry Impact and Future Outlook
The acquisition reflects a broader trend in the pharmaceutical industry toward strategic manufacturing expansion and consolidation, particularly among CDMOs seeking to enhance capacity, geographic reach, and technological capabilities. As demand for biologics continues to grow, companies are increasingly investing in scalable, high-quality manufacturing infrastructure to remain competitive.
Samsung Biologics’ entry into the U.S. manufacturing landscape positions it as a globally integrated biopharma manufacturing powerhouse, capable of supporting a wide range of therapies across multiple markets. The company’s continued investment in the Rockville site underscores its commitment to innovation, regulatory excellence, and long-term growth, while ensuring that critical therapies reach patients efficiently and reliably.
Source: Samsung Biologics, GSK press release
