Fujifilm Diosynth Biotechnologies (FDB) broke ground to signal the start of its expansion project on its North Carolina facility for cell culture and microbial capacity. The 31,778-sq-ft addition will increase cell culture manufacturing by approx. 25% and microbial capacity by approx. 50% through the installation of new recovery and purification suites. according to company officials.
“This expansion is a reflection of Fujifilm’s continued commitment to grow its bio-CDMO business and FDB, to provide our clients with not only the skills, but also the infrastructure that will nimbly deliver their products to the clinic and beyond,” said Martin Meeson, president and COO.
“This project will enable us to further increase our capacity to efficiently meet current and future customer demands in a modern facility,” added Stephenie Robertson, senior director of operations.
The company expects that the increased production capacity will be ready for cGMP manufacture by mid-2021.
FDB also reported that it has begun the planned capacity expansion of its flexible biomanufacturing facility at its College Station, TX. The facility, which is designed to support late phase and commercial manufacturing of gene therapies and other advanced therapies, complements the development and early phase manufacturing capabilities provided by the company from the National Centre for Therapeutic Manufacture, also located in College Station, explains a company official.
The expansion project will include the addition of cell culture and high throughput manufacturing suites. The expanded facility will house multiple 500L and 2000L bioreactors to support the production of gene therapy products that have high production demands. This $35M expansion is part of the previously announced capital investment of approximately 13 billion yen (approx. $120 million) in the gene therapy field by Fujifilm Corp.
“The capacity increase to our flexible manufacturing facility will allow us to support the growing demand for commercial-ready, high volume production of gene therapy products, many of which are in development to treat rare diseases,” said Gerry Farrell, COO, Fujifilm Diosynth Biotechnologies, Texas.
The expansion of the flexible biomanufacturing facility is targeted for completion by fall this year.