CDMOs/CMOs: A Roundup of the Latest Expansions in BiomanufacturingBy
Several CDMOs/CMOs are proceeding with large-scale investments in new biomanufacturing facilities as biologic drug-substance manufacturing continues to be an active area of investment among CDMOs/CMOs. What companies are expanding production capacity?
A roundup of expansion activity
Below is a roundup of recent and ongoing biomanufacturing expansions by large CDMOs/CMOs. For purposes of this article, the roundup includes expansions in traditional biologics; new modalities such as cell and gene therapies are not included.
Samsung Biologics. Samsung Biologics is investing KRW 1.9 trillion ($1.46 billion) for a new biomanufacturing facility in South Korea, which will be the first plant of the company’s second Bio Campus and its fifth biomanufacturing plant overall. The company will invest over KRW 1.9 trillion ($1.46 billion) in the new facility and break ground in the first half of this year (2023) with the aim to commence operations in 2025. Located near the company’s current site in Songdo, South Korea, the new facility will be the fifth plant in the company’s biomanufacturing network and will be the first facility of the company’s second Bio Campus. The new facility will encompass an area of 96,000 m2 with capacity of 180,000 liters. Samsung Biologics purchased 360,000 m2 of land in July 2022 for its second Bio Campus, which will house additional large-scale plants and an open innovation center. Overall, the company will be investing KRW 7.5 trillion ($5.8 billion) in its second Bio Campus.
Upon the full completion of the new facility (Plant 5), Samsung Biologics will have total biomanufacturing capacity of 784,000 liters. The company’s first Bio Campus has four biomanufacturing plants. The company’s existing Plants 1 through 3 are under near-full utilization and its Plant 4, which started partial operations in October 2022, is expected to commence full operations by mid-year 2023 to give the company total capacity at its first Bio Campus of 604,000 liters.
Fujifilm Diosynth Biotechnologies. Fujifilm Diosynth Biotechnologies is investing $2-billion for a large-scale cell-culture biomanufacturing facility in Holly Springs, North Carolina. The company had announced the investment in January 2021. The facility is expected to be operational by the spring of 2025.
The company is also investing a combined $1.6 billion to expand manufacturing at its sites in Hillerød, Denmark, and College Station, Texas. The company is expanding to support large-scale cGMP fed-batch production by adding 8 x 20,000-L bioreactors and two downstream processing streams in its Hillerød, Denmark, facility to provide a total of 20 x 20,000-L bioreactors for drug-substance production as well as drug-product and finished goods services. Fujifilm Diosynth acquired the facility from Biogen in 2019 for approximately $890 million. The company is also adding a new cGMP production facility at its site in College Station, Texas, which will be operational by 2024, and which will double the company’s advanced therapy and vaccine manufacturing capacity in the US.
Last month (April 2023), Fujifilm Diosynth Biotechnologies announced that it had acquired 41 acres of land adjacent to its existing biomanufacturing campus in Research Triangle Park (RTP), North Carolina, to bring the total campus size to just under 119 acres to provide the company room to grow for future capacity for manufacturing and development of biologics.
The company’s RTP campus is comprised of three main buildings, which include: over 170,000 square feet dedicated to GMP manufacturing of biologics; 151,000 square feet of process and analytical development laboratories, of which 89,000 square feet is part of a current expansion; and approximately 60,000 square feet of administration space. The company is currently expanding with the addition of a new BioProcess Innovation Center, which will double the site’s laboratory space and capacity to support process characterization programs. The expanded laboratories will be fully operational in the spring of 2024.
Lonza. Lonza is proceeding with biomanufacturing expansions in the US, Switzerland, and Singapore. The company is investing approximately CHF 850 million ($935 million) to add two mammalian drug-substance manufacturing facilities at its sites in Visp, Switzerland, and Portsmouth, New Hampshire. The expansion in Visp will add a new 27,500-square-meter large-scale mammalian drug-substance manufacturing facility. The facility is expected to be completed in 2024 with an investment of approximately CHF 650 million ($715 million). The expansion will complement the company’s existing large-scale biomanufacturing global network at its sites in Tuas, Singapore; Porriño, Spain; and Portsmouth, New Hampshire.
In Portsmouth, New Hampshire, the company is adding a new biomanufacturing facility for small-to-mid-volume production. The CHF 200-million ($220-million) facility will add capacity for up to eight 2,000-L single-use bioreactors to support Phase III clinical and commercial small- to mid-volume products. The facility is expected to be completed in 2023, and will complement the company’s existing single-use network at sites in Hayward, California; Slough, UK; Tuas, Singapore; and Visp.
Thermo Fisher Scientific. Thermo Fisher recently opened an 86,000-square-foot cGMP facility in Hangzhou, China, an integrated biologics drug-substance and sterile drug-product manufacturing site. The company is also expanding capabilities at its site in St. Louis, Missouri, to support manufacturing and production growth from 2,000 L to 5,000 L with the adoption of new technologies that enable higher yield. A new 58,000-square-foot expansion is slated to be operational in 2023. Also, a new 1.5-million-square-foot biologics manufacturing facility for commercial-scale, large-volume manufacturing in Lengnau, Switzerland became operational in 2022. Additionally, the company added mRNA synthesis capabilities at its site in Monza, Italy, to produce drug substance for vaccines and therapies.
WuXi Biologics. In November 2022, WuXi Biologics launched an integrated contract research, development and manufacturing (CRDMO) center in Fengxian, Shanghai, China. The 1.6-million-square-foot Integrated Biologics CRDMO Center is built with global cGMP standards and can accommodate more than 3,000 employees. The grand opening included research, development, one drug-substance manufacturing facility, and two drug-product facilities for clinical manufacturing at various scales and volumes. Once fully operational, it will be able to provide services from early discovery to commercial manufacturing, all within the center. Additionally, in China, the company released a 48,000-L commercial-scale GMP drug-substance manufacturing facility in Hebei, China in October 2022.
In addition, the company is also investing at sites in the US and Europe. The company launched its first manufacturing facility in the US in Cranbury, New Jersey. The site has 150,000 square feet of space with full development and clinical drug-substance and drug-product cGMP manufacturing capabilities. Drug-substance Phase I expansion was GMP-released in August 2022 with an initial capacity of 4,000 L, which upon completing Phase II, will grow to 6,000 L, using single-use technology. The drug-product facility will be ready for GMP formulation and fill-finish in 2024. In September 2022, the company announced that its 189,500-square-foot site in Worcester, Massachusetts, which is currently under construction, topped-off the steel of this commercial biomanufacturing facility. The company’s site in Dundalk, Ireland, was GMP-released in the fourth quarter of 2022, and received its first GMP Certificate from the Ireland Health Products Regulatory Authority.
Overall, the company has a total estimated capacity of 580,000 L for drug-substance biopharmaceutical production planned by 2026 in the US, Ireland, Germany, Singapore, and China, and over 10 drug-product facilities supporting various presentations (liquid and lyophilization fills, vials, and prefilled syringes).
Catalent. In 2022, Catalent announced a multi-year $350-million investment at its facility in Bloomington, Indiana,to expand biologics drug-substance and drug-product manufacturing capabilities. The expansion includes the installation of new 2,000-liter single-use bioreactors and expanded downstream processing capabilities for drug substances, with batches of up to 4,000-liters using single-use technology, or 5,000-liters using existing stainless-steel bioreactors. Also included are new quality control laboratories and packaging space with additional high-speed, automated cartoning and auto-injector device assembly capabilities.
Also in 2022, Catalent acquired from the Vaccine Manufacturing and Innovation Centre UK Limited a biologics development and manufacturing facility near Oxford, UK. Catalent is investing up to $160 million to complete the building of the facility and equip it with capabilities for the development and manufacture of biologic therapies and vaccines, including mRNA, proteins, and other advanced modalities. In July 2021), Catalent announced that it will begin the first phase of a planned $100-million expansion at its facility in Anagni, Italy, to add biologics drug-substance manufacturing.