An innovation center and additional cGMP manufacturing capacity make up Fujifilm Corporation’s plans to bolster its gene therapy capabilities at its site in Texas.
It is no secret that the demand for gene therapy services is outstripping supply, with a shortage of viral vector capacity meaning contract development and manufacturing organizations (CDMOs) with manufacturing capabilities are rarely struggling to fill their space.
To keep up with industry demand, Fujifilm Diosynth Biotechnologies (FDB) – the CDMO of Fujifilm Corporation – has invested around 13 billion yen ($120 million) into its site in College Station, Texas. $55 million of the investment will be used to establish a Gene Therapy Innovation Center consisting of 6,000 square meters of laboratory space dedicated to gene therapy development. The new building will house process development space and equipment for culture, purification and analysis.
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“According to our internal research, the gene therapy market forecast for CDMOs is expected to grow to $1.7 billion by 2025,” a spokesperson from the CDMO told this publication. “As our partners rely on us to support their efforts in manufacturing gene therapies, we are consistently investing and expanding our knowledge and resources in this key area.”
FDB entered the gene therapy space in 2014 when it acquired Kalon Biotherapeutics, adding the College Station site and viral vector production capabilities.
“Since then, we’ve expanded our offerings and invested in the right talent and technologies to help our partners move swiftly beyond the clinical stage and into production. With a strong track record gene therapy manufacturing experience from Phase I to Phase III, we are confident in building upon our current expertise in this area,” we were told.
In 2018, the plant was expanded to support the fill & finish of Phase III and commercial products through the addition of a Vanrx Pharmasystems’ SA25 automated filler.
“Our main goals behind this [latest] expansion are to provide leading, future proofed end-to-end gene therapy solutions, from pre-clinical to commercial launch.”
GE equipment and growth
The investment will also see FDB up capacity in the clinical and commercial production of gene therapies, adding eight new single-use bioreactors in the 500 and 2,000 L scale.
“We will be using GE single-use technology,” the firm said. “This is consistent with our current platform and carries the benefits associated with single-use technology.”
Both the innovation center and the first stage of the manufacturing expansion is expected to be completed and operational in 2021.
The news is the latest expansion by FDB across the bioproduction space. At the beginning of the year, the firm ploughed $90 million into its mammalian and microbial manufacturing site in Morrisville, North Carolina and $21 million into a site in Wisconsin to make industrialize human induced pluripotent stem (iPS) cells for its cell therapy customers. Months later, the CDMO acquired a 90,000 L mammalian cell culture from Biogen in Hillerød, Denmark for $890 million.
“FDB is growing at a rapid pace and we will continue to do so in order to meet our customers’ production needs,” the firm told us.