Domestic CXOs are restricted in the US, while Fujifilm's CDMO gets the green light

On April 11th, Fujifilm announced a $1.2 billion investment in its large-scale cell culture CDMO business, aimed at further expanding its large biomanufacturing facility in Holly Springs, North Carolina, with total investment exceeding $3.2 billion.

This expansion adds significant large-scale production capacity to FUJIFILM Diosynth Biotechnologies' global network through its US and European manufacturing centers.

"This investment is an important step in accelerating the growth of our biopharmaceutical CDMO business," said Teiichi Goto, President and CEO of Fujifilm Corporation.

Toshihisa Iida, Vice President of Fujifilm Corporation and Chairman of Fujifilm Diosynth Biotechnologies, stated, "We are pleased to continue investing to enhance our cell culture production capabilities in North Carolina to meet the growing outsourcing needs of biopharmaceutical companies."

Governor Cooper of North Carolina commented, "The expansion of Fujifilm Diosynth Biotechnologies in Wake County creates new job opportunities, another example of the flourishing economic relationship between North Carolina and Japan. We appreciate their continued investment in our state."

While both are CXO companies, the differential treatment towards domestic companies like BGI Genomics and WuXi AppTec due to the recent US "Biosecurity Act" restrictions should not be overlooked.

However, through Fujifilm's investment, it's evident that there is still demand in the US for pharmaceutical outsourcing services. After restricting Chinese biotech companies and CXOs, the US urgently needs to find alternatives, and FUJIFILM Diosynth Biotechnologies under Fujifilm's umbrella is one of them.

Fujifilm is a well-known company, but what are the highlights of its biopharmaceutical subsidiaries?

Film production and pharmaceutical production both on the agenda

According to the official website, Fujifilm Diosynth Biotechnologies is a subsidiary of Fujifilm Corporation and a world-leading contract development and manufacturing organization (CDMO) partner, dedicated to the development and manufacturing of biologics, vaccines, cell and gene therapies, and oncolytic viruses.

FUJIFILM Diosynth Biotechnologies has over 30 years of experience in developing and manufacturing recombinant proteins, vaccines, monoclonal antibodies, large molecules, virus products, and medical countermeasures expressed in various microbial, mammalian, and host/virus systems.

Moreover, the company offers a comprehensive service list, from cell line development using its proprietary pAVEway? microbial and Apollo?X cell line systems to process development, analytical development, clinical, and FDA-approved commercial production.

The aforementioned expansion plan is a key component of FUJIFILM Diosynth Biotechnologies' Life Partner Strategy, aimed at establishing large-scale production capabilities in the United States and Europe to support the end-to-end needs of biopharmaceutical customers and provide supply chain resilience, ensuring seamless drug manufacturing integration regardless of location.

The plan involves investing in adding 8 20,000-liter mammalian cell culture bioreactors to its large cell culture facility in Holly Springs to further expand its production capacity.

This will increase the number of bioreactors at the site to 16 by 2028, making it one of the largest cell culture biopharmaceutical CDMO facilities in North America. The expansion also includes additional construction at the production site in North Carolina, increasing its area by 425,500 square feet to support future growth.

The facility is expected to be operational by 2025.

In recent years, a series of significant events in the field of cell therapy manufacturing by Fujifilm demonstrates its continued investment and expansion in this area:

• In December 2023, Fujifilm invested $200 million to enhance the cell therapy production capabilities of its subsidiary FUJIFILM Cellular Dynamics' new headquarters and FUJIFILM Diosynth Biotechnologies' California facility.
• On November 12, 2022, Fujifilm invested $188 million to establish a cell culture-based production facility in Research Triangle Park (RTP), North Carolina, further enhancing its manufacturing capabilities in the field of cell therapy.
• In June 2022, Fujifilm invested $1.6 billion to expand the cell culture manufacturing services of its CDMO subsidiary FUJIFILM Diosynth Biotechnologies.
• On April 12, 2022, ChimeronBio signed a manufacturing agreement with FUJIFILM Diosynth Biotechnologies to advance its RNA tumor candidate drug. This indicates Fujifilm's collaboration with partners in the field of cell therapy manufacturing and support for the development of emerging therapeutic approaches.
• On April 4, 2022, Fujifilm announced the acquisition of dedicated cell therapy manufacturing facilities from Atara Biotherapeutics for $100 million. This acquisition further strengthens Fujifilm's position in the field of cell therapy manufacturing, expanding its production capacity and service scope.
• In early 2021, Fujifilm invested $40 million to build a new facility in Boston, tripling its viral vector manufacturing capacity, and plans to start providing contract manufacturing services for gene therapy developers in 2023. This move demonstrates Fujifilm's expansion plans in the field of gene therapy and investment in enhancing production capacity.

Conclusion

The global CXO industry is indeed undergoing a series of adjustments and reshaping. In addition to Fujifilm injecting new production funds, companies like Lonza and Charles River are also making significant investments in expanding their biologics businesses, especially in mammalian cell culture production facilities.

Lonza has also made several significant moves this year, including the closure of its biotechnology plant in the Guangzhou Development District, China, and the acquisition of Roche's production facility in Vacaville, California. These actions aim to increase the company's commercial mammalian product output and expand its production capacity in the United States. This also indicates that this global top-tier CDMO company is adjusting its global production capacity layout.

What will be the result of these adjustments and reshaping? We will continue to keep an eye on it.