RESEARCH TRIANGLE PARK – North Carolina wins.
FUJIFILM Corporation today ended a high-stakes economic development drama by announcing that Holly Springs, N.C., is officially its choice for siting a huge $2 billion biomanufacturing site.
The decision will add 725 more jobs to the region’s globally leading cell- and gene-therapy manufacturing workforce with an average salary just under $100,000 a year. Upon completion, the company says it will be the largest end-to-end biologics production facility in the world. It’s also the largest single life sciences investments in the state’s four-decade history of growing the sector.
It caps a search process publicly announced in early January that spanned the United States to accelerate the growth of the Japanese conglomerate’s biopharmaceutical contract development and manufacturing (CDMO) business.
A rendering of the future Holly Springs facility as provided by Fujifilm.
CDMO refers to companies offering services to pharmaceutical companies such as cell-line and process development, stability testing, the development and manufacturing of clinical-trial drugs as well as commercial drug manufacturing.
North Carolina’s strengths
FUJIFILM’s story of end-to-end development is right at home in North Carolina, where partners across many organizations collaborate to take ideas from university research to startup company, through the rocky road of product development to manufacturing and distributing the final product. FDB’s gene therapy production capacity joins a cluster of companies making their cell- and gene-therapy products here. Since 2017, 10 companies announced $1.4 billion in facilities investments in North Carolina.
https://wraltechwire.com/2021/03/18/fujifilm-picks-triangle-for-1-5b-drug-product-manufacturing-facility-hundreds-of-jobs/
North Carolina is known globally as a magnet for biopharmaceutical manufacturing. In August 2015 the Danish giant Novo Nordisk announced a five-year plan to invest up to $1.7 billion and create approximately 700 jobs at a new biomanufacturing facility in Johnston County, doubling its then-existing workforce in the state. In October 2020 BioAgilytix, one of North Carolina’s fastest-growing home-grown life sciences companies, unveiled plans to add 878 new employees to its workforce of 425, with a $61.5 million investment in its global Durham headquarters. The privately held company provides contract services to pharmaceutical and biotech companies internationally.
To help grow North Carolina’s globally recognized biomanufacturing workforce, NCBiotech recently launched a unique recruitment program called Bio Jobs Hub, especially targeting people without advanced degrees who may not realize they could qualify for excellent career opportunities in the field.
Statewide, North Carolina currently has 775 life sciences companies employing more than 67,000 people. The state is globally recognized for its workforce training system, ranging from specialized courses for graduating high school students through world-class universities providing graduate programs in cutting-edge scientific disciplines.
Fujifilm Diosynth
The state is not only the birthplace and global epicenter of the contract research and testing industry, but also a renowned hub of biomanufacturing, with 130 companies employing 27,000 people, including national leadership in the kind of biological product manufacturing done by FDB. Today’s announcement is expected to increase North Carolina’s visibility as a leading site for moving technology from its inception as an idea through every phase of development and into the marketplace.
The Fujifilm North Carolina connection
FUJIFILM has set a target to achieve an annual revenue of some $200 billion for its Bio CDMO business by fiscal year ending March 2025. Beyond the fiscal year ending March 2026, the company expects this latest investment to boost the annual growth rate of its Bio CDMO business to 20%, greatly exceeding market projections.
FUJIFILM Diosynth Biotechnologies (FDB), a Morrisville-based subsidiary of the FUJIFILM Corporation, of Tokyo, will operate the new facility. FDB is an industry-leading CDMO with other locations in College Station, Texas; Teesside, England; Hillerød, Denmark; and a soon-to-open facility in the Boston suburb of Watertown.
When the parent company announced plans for the new facility early this year, it said it would locate the new FDB facility in the vicinity of an existing U.S. FUJIFILM site, though not necessarily near its FDB biotech facilities. That left some 25 communities nationwide vying for the factory with a range of financial incentives and other competitive pitches.
“Identifying a place to locate a biomanufacturing project of this magnitude hinges on the availability of highly trained people, a top-notch business climate, and a hyper-collaborative ecosystem, all within a strong, diverse life sciences cluster. And that place is North Carolina,” said Bill Bullock, senior vice president of economic development and statewide operations with the North Carolina Biotechnology Center. NCBiotech provided technical and other support to the state’s recruitment team.
“Holly Springs in particular is a model community in how to develop and implement a long-term strategy to attract life science jobs and investment, going back to Novartis’ decision to locate its vaccine campus there in 2006.”
The Novartis Vaccines facility was sold to Seqirus, which produces flu vaccines from cell culture at the Holly Springs factory.
The partnership recruiting process
Partners collaborating on the recruitment project, besides NCBiotech, include the General Assembly, the Economic Development Partnership of North Carolina, the North Carolina Department of Commerce, Wake County Economic Development, the Town of Holly Springs, Wake Tech and the North Carolina Community College System/BioNetwork, North Carolina State University and its Golden LEAF Biomanufacturing Training and Education Center, and North Carolina Centra University and its Biomanufacturing Research Institute and Technology Enterprise.
In its January announcement, the company said when its new facility begins operations in the spring of 2025 it will conduct large-scale cell culture manufacturing of bulk drug substance using eight 20,000-liter (5,283-gallon) bioreactors for growing mammalian cells. Plans for the site included the potential to expand and add up to 24 more of those bioreactors, based on market demand.
In addition to drug substance manufacture, the facility will also provide commercial-scale, fully automated fill-finish and assembly of a variety of syringes, and equipment for automatic packaging and labeling.
“The United States is the world’s biggest market for biopharmaceuticals. I am pleased that through this large investment in the U.S.A we are able to support the development and manufacturing of new drugs that can help fulfill unmet medical needs”, said Kenji Sukeno, president of FUJIFILM Corporation. “FUJIFILM will continue to promote human health and support the progress of the healthcare industry by using our cutting-edge technology and advanced facilities to provide a stable supply of high-quality biopharmaceuticals.”
FUJIFILM is actively investing to enhance and grow its end-to-end service offerings across all of its biologics CDMO sites, which the company has named its “Bio CDMO division.” In June 2020, it invested $928 million in FDB’s Denmark site to double its large-scale cell culture manufacturing capacity and add commercial-scale drug product production capabilities.
“We are leveraging our strengths in process development and manufacturing for a wide range of biopharmaceuticals such as antibodies, recombinant proteins, gene therapies and vaccines,” said Martin Meeson, Morrisville-based CEO of FDB. “We are uniquely placed to support our customer supply chain needs providing end-to-end services from small- to large-scale bulk drug substance production, through to fill-finish and final packing.”
The 450+ employees at the company’s expanding Morrisville facility produce more than 60 products. In July 2020 it partnered with Novavax to help produce that company’s COVID-19 vaccine, which is awaiting final marketing approval from the U.S. Food and Drug Administration.
About FUJIFILM Corp.
FUJIFILM Corporation is an operating company of FUJIFILM Holdings Corporation. It brings cutting-edge solutions to a broad range of global industries including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar.
About FUJIFILM Diosynth Biotechnologies
FDB has over 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 X cell-line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FDB is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.
