Expansions in biomanufacturing (biologic drug substances) continues to be an active area of investment by CDMOs/CMOs. Which companies are expanding? DCAT Value Chain Insights rounds up the latest developments.

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Large-scale expansions
Several companies are proceeding with large-scale biomanufacturing expansions as outlined below.

Lonza is investing CHF 500 million ($571 million) at its site in Vacaville, California, to increase its large-scale mammalian manufacturing capacity for commercial products and products in late-stage development. Lonza acquired the site in late 2024 from Roche’s Genentech for $1.2 billion. The site has total capacity of 332,000 L across 19 bioreactors. 

Fujifilm Diosynth Biotechnologies is advancing two large-scale biomanufacturing expansions. The company is proceeding with continued investment at its site in Hillerød, Denmark. The first investment of $928 million added six 20,000-L bioreactors, effectively doubling its commercial monoclonal antibody production capacity. This new capacity became operational in November 2024. An additional $1.6-billion expansion at the site is scheduled to be operational in 2026.

The company is also expanding its site in Holly Springs, North Carolina, with an initial $2-billion investment in an end-to-end large-scale cell-culture biomanufacturing facility, which will include eight 20,000-L bioreactors to be operational by the summer of 2025, and an additional $1.2-billion expansion for 8 x 20,000 L mammalian cell-culture bioreactors to be operational by 2028. The company is also investing in small-to-mid-scale capacity at its sites in Billingham, the UK, and Toyama, Japan. 

Samsung Biologics launched its Bio Campus II, with the first plant in that biocampus and its fifth biomanufacturing facility overall, becoming operational this month  (April 2025) at its site in Songdo, Incheon, South Korea. Plans for a second plant in Bio Campus II and the company’s sixth overall are under review by the company, which if approved, would expand the company’s total biomanufacturing capacity to 964,000 liters. 

Last year (2024), Lotte Biologics broke ground on its inaugural plant at its Songdo Bio Campus in Incheon International City, South Korea, the first plant of a $3.3-billion biocampus that the company is establishing. Lotte Biologics entered the CDMO market with the acquisition of a commercial-scale biomanufacturing facility in Syracuse, New York, from Bristol-Myers Squibb in January 2023. The new facility is part of a previously announced $3.3-billion expansion plan to build three biomanufacturing plants at a new biocampus in South Korea by 2030 that will provide total production capacity of 360,000 liters, with each plant having 120,00 liters of production capacity. The new biocampus spans 202,285 square meters. In January (January 2025), the company reported that the first plant at its Songdo Bio Campus, which represents an investment of $1 billion, is slated to to commence full-scale commercial production by 2027.

Thermo Fisher is bringing eight new bioreactors on line in 2025 (4 x 5,000-L single-use bioreactors in Lengnau, Switzerland, and 4 x 2,000-L single-use bioreactors in St. Louis, Missouri). It is also bringing on line an expanded CHO-K1 cell-line offering and its Rapid Development Framework, used to accelerate development and manufacturing of cell and gene therapies, for broad-range viral vectors and cell therapies. 

AGC Biologics is proceeding with a new JPY 50-billion ($350-million) biomanufacturing facility in Yokohama, Japan. with GMP operations beginning in 2027. The new facility will offer support from initial process development work for early-phase projects to late-phase and commercial production. It will support mammalian expression, cell therapy, and messenger RNA (mRNA) drug products. In addition, last June (June 2024), the company completed a new $200-million biomanufacturing building at its Copenhagen, Denmark, campus. The building doubled the site’s single-use bioreactor capacity for mammalian services and allowed it to produce 150 more batches of drug product each year.

WuXi Biologics is set to commence operations at a new Singapore facility in late 2025, starting with an inaugural site tour scheduled for September 24, 2025. Representing a $1.4-billion investment, the facility spans 13.5 hectares (135,000 square meters) in Tuas Biomedical Park and adds 120,000 L of bioreactor capacity to support biologics manufacturing at both clinical and commercial scales. The Singapore site joins WuXi Biologics’ global network, which currently operates in four other countries. The facility will become operational in phases, with WuXi XDC serving as the first tenant. WuXi XDC is a subsidiary specializing in antibody-drug conjugates and bioconjugates.