The company declined to disclose the exact location of the facility, although stated it would be built within the vicinity of an existing Fujifilm site. Fujifilm is reported to have a total of 25 sites across the US.

Scheduled to start operating in the spring of 2025, the facility will house eight 20,000-liter bioreactors, with the potential to add a further 24 reactors of the same size, depending on market demand. As well as drug substance manufacture, the site will also provide commercial-scale, automated fill-finish and assembly, packaging and labelling services.

“The US is the world's biggest market for biopharmaceuticals. I am pleased that through this large investment in the USA we are able to support the development and manufacturing of new drugs that can help fulfill unmet medical needs,” said Fujifilm president Kenji Sukeno.

Fujifilm has set a goal of achieving annual revenue of 200 billion yen for its bio-CDMO business by the fiscal year ending March 2025. Beyond the fiscal year ending March 2026, the Tokyo-headquartered group expects this latest investment to boost the annual growth rate of its bio-CDMO business to 20%, greatly exceeding market projections.

Last June, Fujifilm announced it would double large-scale cell culture manufacturing capacity and add commercial-scale drug substance production at Hillerød, Denmark, at a cost of $928 million. The extra capacities are due online in 2023.

New viral vector plant to cost $20 million

In separate news, the company has also announced its intention to spend $40 million on a new viral vector and advanced therapy process development and manufacturing facility in the greater Boston area, Massachusetts, USA.

The site – Fujifilm Diosynth Biotechnologies’ third for viral vector CDMO services – will begin process development operations in the fall of 2021. Contract manufacturing services for early phase clinical trials will be available from fall 2023.

Martin Meeson, CEO of Fujifilm Diosynth Biotechnologies, said the company is locating the additional capabilities in greater Boston because the area has a high concentration of biopharmaceutical companies and academia working on advanced therapies.

Since establishing its first viral vector manufacturing facility in 2014 at its site in College Station, Texas, USA, Fujifilm has continued to invest in viral vectors, which are used in gene therapy to treat or prevent disease.

In October last year, the company said it was adding viral vector process development and GMP manufacturing services at its site in Billingham, northeast UK. The process development laboratories will be online from spring this year with the GMP manufacturing capabilities expected to be available from fall 2021.

Takatoshi Ishikawa, senior executive vice president, general manager of Fujifilm’s Bio-CDMO division, said the initial investment “will lay the groundwork to further grow our manufacturing services for gene therapies in Europe.”

Author: Elaine Burridge, Freelance Journalist