The states currently boasts 94 biopharma manufacturing sites employing 28,000 people: ranking it the third in the US for pharma manufacturing. In cell and gene therapy, the Research Triangle Region boasts everything needed to bring therapies from conception to commercialization. And looking forward, the established life science ecosystem is ready to bring emerging therapies to market.
Building a biotech hub
In the early 1980s, three of North Carolina’s largest industries – tobacco, textiles and furniture – were in decline.
“North Carolina leaders, from business to policymakers, recognized that genetic engineering and other new technologies coming out of bioscience research labs had enormous potential. They also knew agriculture and medicine – the state’s largest industries – were areas that new technology could transform,” Christopher Chung, CEO of The Economic Development Partnership of North Carolina (EDPNC), told BioPharma-Reporter.
“In 1984, the state’s elected and business leaders established the North Carolina Biotechnology Center (NCBiotech) in Research Triangle Park. The independent, non-profit corporation became the nation's first state-sponsored initiative in life sciences development with a goal to create high paying jobs, strengthen universities and encourage new company formation.”
Research Triangle Park is now the largest research park in the US with 7,000 acres housing more than 300 companies: not only in biopharma but also in wider science and technology sectors.
“Located in the heart of the state’s triangle of Raleigh, Durham and Chapel Hill, Research Triangle Park (RTP) is the world’s original research park and a major life sciences and tech magnet that has created a thriving life sciences ecosytem, which has since grown state-wide.”
Cell and gene therapies
Today, the life sciences sector generates more than $83.3bn in annual economic impact and nearly $2.2bn in state and local government tax revenues.
There are more than 790 life sciences companies in NC, ranging from entrepreneurial startups to multinational conglomerates including Eli Lilly, Pfizer, FUJIFILM Diosynth Biotechnologies, Labcorp, IQVIA, PPD clinical research services, Merck, Thermo Fisher, Novartis, Novo Nordisk, BASF, Biogen, Baxter among others.
This includes over 250 companies and more than 50,000 workers supporting biotechnology and pharmaceuticals industries alone: which has grown 25% since 2010.
The cell and gene therapy industry in particular has been spurred on by bringing together expertise in academia and investment.
The Research Triangle now has everything needed to bring gene and cell therapies to market: through from conception to commercialization. An early start in the industry has helped the sector, with the University of North Carolina at Chapel Hill one of the original birthplaces of gene therapy research and now home to the UNC School of Medicine Gene Therapy Center, founded in 1993 by pioneer R. Jude Samulski, PhD.
Most recently, Pifzer announced in December it would pump another $68.5m into a new facility in Durham to advance gene therapy capabilities.
Pfizer’s $800m investment to build three scalable, state-of-the-art gene therapy manufacturing facilities includes 300,000 square feet of capacity, one of the largest in-house gene therapy manufacturing facilities, to support multiple gene therapy medicines.
This includes a total bioreactor manufacturing capacity of 22,000 liters, (2,000 liters / bioreactor x 11 bioreactors) using single-use manufacturing technology, allowing more scalable expansion of manufacturing capacity over time. These investments have given Pfizer one of the largest production capacities for gene therapy vectors globally.
“North Carolina is a leading hub for cell- and gene-based therapies. Beginning with announcements from Pfizer and bluebird bio in 2017, companies promised to invest $1.1bn and create 1,600 jobs through 2020.
“The roster of related companies includes Audentes (an Astellas company), Beam Therapeutics, Biogen, Cellectis, Jaguar Gene Therapy, Kriya Therapeutics, Novartis Gene Therapies, Sio Gene Therapies, StrideBio and Taysha Gene Therapies. Home-grown entrepreneurial companies AskBio, Atsena Therapeutics, Locus Biosciences, Precision BioSciences and Stride Bio continue to push cell and gene therapies forward.”
Another strength for the state is the largest global concentration of contract research and testing organizations.
"The world's first clinical trials management company started on the UNC campus. Today it’s IQVIA, with 75,000 global employees in 100 countries. Other global leaders in this class of CRO with North Carolina headquarters include PPD, now part of Thermo Fisher Scientific, PRA Health Sciences, Parexel and Syneos Health. Labcorp leads the diagnostic and testing space from its headquarters in Burlington."
Building up skills
Skills shortages are a well-known problem for the industry, and North Carolina hopes to tackle this with its strong academic institutions such as Duke University, the University of North Carolina at Chapel Hill, North Carolina State University, East Carolina University and Wake Forest University
Furthermore, the state has mechanisms in place to connect research and academic with funding and business opportunities.
"NCBiotech works to connect companies with university researchers and introduce entrepreneurs to potential funders. Transformation even happens on an individual level as job seekers find opportunity in the life sciences field," explained Chung.
North Carolina is a leader in forming public/private partnerships to benefit the state’s economy via the life sciences, he adds. In December, a coalition led by NCBiotech and EDPNC was awarded $500,000 in the federal Build Back Better Regional Challenge award: thanks to a wide-ranging proposal entitled “Accelerating Life Science Manufacturing to Create Economic Resilience and Promote Equity in Distressed North Carolina Communities.
The Economic Development Partnership of North Carolina (EDPNC) is focused on recruiting new businesses to the state, supporting the needs of existing businesses, connecting exporters to global customers, and helping small business owners get their start.
It works closely with public- and private-sector partners at the state, regional and local levels.
As a nonprofit public-private partnership, the EDPNC operates under contract with the North Carolina Department of Commerce, while receiving additional financial support from the private sector. It is governed by an 18-member board of business and industry leaders.
"The Phase 1 award is helping academia, industry, state and local government, and other partners to work together to develop strategies that can expand, connect, scale, and promote the state’s life sciences manufacturing cluster."
In manufacturing, North Carolina has 58 community colleges providing training for careers in biopharma manufacturing including programs developed in collaboration with employers to train workers in specific skills.
“As innovative approaches and curative therapies emerge and bring new hope to patients with rare diseases, the state’s established life science ecosystem, including some of the world’s largest clinical research organizations, is well-positioned to move these life-changing therapies from concept to market.”