DATA & ANALYTICS

“ This fully-integrated approach offers significant advantages for our partners, including faster timelines, smoother tech transfers and, most importantly, the trust that comes from collaborating with the same production partner throughout the lifecycle of a drug.”

The scale of Fujifilm’ s investment underscores its commitment to this vision. The company has invested more than US $ 3.7bn in Fujifilm Biotechnologies to expand its CDMO capabilities and footprint in the US, with at least US $ 3.2bn specifically devoted to North Carolina operations.

The Holly Springs facility, with phase one operations coming online by the end of this year, spans nearly one million square feet and features eight 20,000-litre mammalian cell culture bioreactors for bulk drug substance production, with drug product capabilities to follow in mid-2026 and finished good capabilities shortly thereafter. A second phase expansion, planned for completion in early 2028, will add another eight 20,000-litre bioreactors, further expanding capacity to meet growing demand.

Investment specifically devoted to North Carolina operations

Addressing cell and gene therapy challenges The promise of personalised medicine through cell and gene therapy represents one of the most exciting frontiers in healthcare, offering potential cures for previously untreatable genetic disorders and cancers.

Yet this field faces significant hurdles, particularly around manufacturing scalability and cost. Unlike traditional small-molecule drugs or even conventional biologics, cell and gene therapies often require individualised manufacturing processes, dramatically increasing complexity and expense.

John acknowledges the current challenges:“ While the promise of gene and cell therapy remains strong, the industry has been impacted by the short-term challenge of reduced venture capital investment in early-stage therapies. Many of these programmes in the early phase pipeline have been paused due to the heavy cost burdens associated with manufacturing and running multiple, parallel clinical trials.”

This funding environment has prompted a strategic shift in the industry, with companies moving away from small-volume orphan disease indications towards larger clinical indications that can achieve commercial viability more quickly.

“ As such,” John goes on,“ cell and gene therapy companies are shifting their focus away from smaller volumes for orphan disease indications, for example, to larger clinical indications.”

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