RESEARCH TRIANGLE PARK – Another major biopharmaceutical manufacturing expansion is being planted in North Carolina soil.

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDB) has broken ground on a $54 million, 31,778-square-foot expansion of its biomanufacturing facilities in Morrisville. The investment in its contract development and manufacturing organization (CDMO) business is part of a $90 million Fujifilm Corporation commitment to meet growing customer demand for biopharmaceuticals.

The expansion will increase cell culture manufacturing capacity by about 25 percent and microbial capacity by about 50 percent at the firm’s campus at 101 J. Morris Commons Lane in Morrisville. It will include the addition of 2,000-liter single-use cell culture manufacturing trains, cell culture purification suites and new microbial recovery suites.

Fujifilm Diosynth image

Fujifilm Diosynth

FDB will also attach a receiving warehouse to the opposite side of its existing building, though final dimensions of that project are still being determined.

The company expects the increased production capacity will be ready for contract Good Manufacturing Practices (cGMP) production by mid-2021, about a year later than initially announced a year ago. The company said it will determine hiring needs as it gets closer to opening the new addition, but it expects to add to its existing 450-person payroll at the site.

“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, FUJIFILM Diosynth Biotechnologies, U.S.A., Inc.The company is focused on the development and manufacture of recombinant biopharmaceuticals including proteins, advanced therapies, and monoclonal antibodies.

“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 for the company, at the ground-breaking ceremony.

Representatives of the North Carolina Biotechnology Center were among invited guests at the recent groundbreaking event. Supporters from other local organizations included partners from the Economic Development Partnership of North Carolina, The RTP Foundation, North Carolina Biosciences Organization, and the Morrisville Chamber of Commerce, among others.

In 2016 the company opened a 62,000-square-foot facility on its Morrisville campus for its bioprocess R&D groups. That building, called the BioProcess Innovation Center, houses the company’s process and analytical R&D, process sciences and stability groups.

Fujifilm, like dozens of other major pharmaceutical and biomanufacturing companies, has been attracted to North Carolina because of the state’s workforce training programs targeting their specialized life science requirements. It has transformed the state into a global life science leader.

The parent company, FUJIFILM Holdings Corp. of Tokyo, is a global conglomerate with chemical, mechanical, optical, electronic and imaging technologies that are used in healthcare, graphic systems, materials, optical devices, digital imaging and document products.

FUJIFILM Diosynth Biotechnologies also has locations in College Station, Texas, Teesside, UK,  and Hillerod, Denmark. The company has more than 30 years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems.

The company offers a comprehensive list of services from cell line development using its proprietary pAVEway microbial and Apollo cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing.

FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.

(C) N.C. Biotech Center