North Carolina: A Thriving Biopharma Manufacturing Hub
NCBiotech uses “biopharma manufacturing” to describe biopharmaceutical and small-molecule pharmaceutical manufacturers, plus manufacturers of industrial enzymes and R&D products
With nearly 34,000 employees at 108 biopharma manufacturing sites, North Carolina is home to one of the largest concentrations of biologics and pharmaceutical manufacturers in the world, a diverse workforce, and startup companies that are at the forefront of today's most innovative technologies. N.C.'s statewide network of industry-driven workforce solutions provides students and companies with hands-on training in state-of-the-art facilities.
North Carolina biopharma manufacturing sites produce an array of products, including small-molecule therapeutics, monoclonal antibodies, industrial enzymes, and vaccines. In recent years, N.C.'s biopharma manufacturing industry has expanded as novel technologies, including cell- and gene-based therapies, have moved from research laboratories to commercial manufacturing.
The state's extensive training programs deliver skilled talent to global leaders, including Baxter, Biogen, Lilly, Grifols, Merck, Novo Nordisk, Novonesis, Pfizer, CSL Seqirus, Thermo Fisher Scientific and more.
Biopharma Manufacturing Landscape in NC
Source: NCBiotech Business Intelligence & Analytics
Cell- and Gene-based Therapy Manufacturing
North Carolina has quickly established itself as a leading hub for cell- and gene-based therapies. As innovative approaches and curative therapies emerge and bring new hope to patients with rare diseases and cancer, North Carolina’s established life science ecosystem is well-positioned to move these life-changing therapies from idea to market.
The state’s cell- and gene-based therapy sector is supported by world-class research, a strong foundation in biopharma manufacturing, numerous resources, top talent, and an exceptional business climate.
Below are some companies across the state that are manufacturing cell and gene therapy products.
Sanford
Astellas Gene Therapies is establishing a $109.4 million, 209-employee gene therapy production facility in Lee County. Expansion phases are planned for the next two years. Hiring started in 2020 and will grow through 2026.
Raleigh
In 2019, Paris-based biotechnology company Cellectis announced plans to invest nearly $70 million and create 200 jobs in Raleigh, at what will become its first North American manufacturing facility.
Morrisville
FUJIFILM Diosynth Biotechnologies USA, a global contract development and manufacturing organization (CDMO), will expand its BioProcess Innovation Center in Research Triangle Park, creating 145 jobs by 2024. The 89,000-square-foot addition will double the company’s laboratory footprint.
Durham
Novartis Gene Therapies, formerly known as AveXis, intends to use its new Durham facility to manufacture ZOLGENSMA, its first FDA approved gene therapy to treat three types of spinal muscular atrophy, or SMA. SMA Type 1 is the leading genetic cause of infant mortality.
Sanford & Durham
Following Pfizer’s 2016 acquisition of Bamboo Therapeutics, its gene therapy footprint in North Carolina has continued to grow. Pfizer began to build out gene therapy manufacturing capacity at its Sanford vaccine production site in 2017, and has since announced plans to invest another $500M and create 300 more new jobs to strengthen its gene therapy capabilities. Additionally, a 60,000-square-foot building will be renovated to house Pfizer’s Advanced Therapy Medicinal Product facility in Durham.
Durham
Precision BioSciences recently opened its production facility for in-house manufacturing of its unique technologies. The facility is the first in-house cGMP-compliant manufacturing facility in the U.S. dedicated to genome-edited, off-the-shelf chimeric antigen receptor (CAR) T cell therapy products.
Industry Leaders Across the State
Statewide Training
A career in biopharma manufacturing is rewarding. These well-paying jobs contribute to the creation of products that positively impact lives around the globe. As biopharma manufacturing companies continue to expand operations in North Carolina, the need to fill a variety of roles remains critical.
Below are a few training institutions across the state that specialize in biopharma manufacturing training.
Additional Learning Opportunities
Whether you are looking to jumpstart your career out of high school or working professional seeking to update your skills, North Carolina has created a variety of opportunities to succeed in this sector.
The Biopharma Manufacturing Education Resources is a compilation of statewide training courses organized by education level and region.
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NC BioNetwork
BioNetwork is the N.C. Community College System’s life science training initiative that includes:
- BioWork Certificate Program - The BioWork certificate program is a 136-hour course that teaches the foundational skills needed to begin a career as a process technician for a biotechnology, pharmaceutical, or chemical manufacturing company. Process technicians are responsible for the production of chemical and pharmaceutical products.
- Open enrollment and customized courses and workshops for incumbent employees and transitional workers
- Hands-on activities for students and professional development for K-14 teachers
- Capstone Center - Industry-grade tools and a certified cleanroom suite mirror a pharmaceutical manufacturing facility. The Capstone Center is located in the Golden LEAF BTEC building on NC State's Centennial campus in Raleigh.
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Biomanufacturing Technology & Education Center (BTEC)
Biomanufacturing Technology & Education Center (BTEC) at North Carolina State University uses the latest biomanufacturing technologies to provide hands-on learning opportunities including:
- Undergraduate minor, Professional Science Master’s degrees, and both undergraduate- and graduate-level certificates
- Open enrollment and customized short courses for industry professionals
- Contract bioprocess and analytical services
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Biomanufacturing Research Institute and Technology Enterprise (BRITE)
Biomanufacturing Research Institute and Technology Enterprise (BRITE) at North Carolina Central University provides hands-on learning opportunities including:
- Undergraduate and graduate degree programs
- Internship and on-campus research experiences
- Outreach and community programs for students and teachers
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The North Carolina Pharmaceutical Services Network (PSN)
The North Carolina Pharmaceutical Services Network (PSN) is a collaboration between East Carolina University and Pitt Community College providing a continuum of training including:
- Oral Solid Dose short course for students and new and incumbent pharma employees
- Graduate level GMP courses
- Analytical services for government, academia, and industry
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The Eastern Region Pharma Center (ERPC) at ECU
A four-story, 141,500-square-foot interdisciplinary research facility houses bioprocess engineering labs, the Eastern Region Pharma Center, and the Department of Biology.
The facility supports programs in biotechnology, bioprocess engineering, biophysics, environmental engineering, and plant biology. It also features dedicated bioprocess engineering labs with bioreactor equipment simulating industry conditions.
ERPC’s goals include:
- Increase pharma awareness and workforce preparedness through its Pharma Pathways Initiative
- Increase the opportunities, capabilities, and productivity of associate and bachelor’s degree graduates
- Increase ECU’s readiness to re-skill, up-skill, and new-skill incumbent employees
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National Center for the Biotechnology Workforce
The National Center for the Biotechnology Workforce is a Forsyth Technical Community College and NC Community College System program that prepares workers for in-demand jobs in advanced technologies to help maintain U.S. competitiveness in a global economy.
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NCBioImpact
NCBioImpact combines the resources of North Carolina's university and community college systems to meet the growing demands of the biotechnology and pharmaceutical industries. The training programs partner closely with NCBiotech, NCBIO, the Department of Commerce and industry to form a unique academic, industry and government collaborative.
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Biomanufacturing and Process Development (BPD)
BPD’s mission is to provide a forum for process development and manufacturing scientists and engineers to discuss bioprocessing issues. The group meets approximately eight to ten times a year with speakers from academia, industry, technology vendor experts, and regulatory experts. This is one of the 20-plus Exchange Groups that are supported statewide by NCBiotech.
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BioPharma Crescent
The BioPharma Crescent is a five-county region located in Eastern North Carolina, about halfway between Raleigh and the Atlantic Ocean. The region is home to major biopharma manufacturers such as Grifols, Novo Nordisk, ThermoFisher Scientific, Pfizer and more. Colleges, universities, and a biopharma-specific training network provides local businesses with a highly educated and well-trained workforce.
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National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry.
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NCLifeSci
NCLifeSci is the trade association for North Carolina’s life science industry. Members include companies and research institutions working in the pharmaceutical, medical device, diagnostic, clinical research and agricultural biotechnology sectors, as well as firms and nonprofits that provide support services to life science companies.
NCLifeSci coordinates regular meetings of the Biotech Manufacturers Forum (BMF) to help late-clinical and commercial-phase biopharma manufacturing companies and related firms, including vendors and service providers, share information and address common concerns.
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North Carolina Association for Biomedical Research (NCABR)
NCABR plays a leading role in North Carolina and the nation by providing objective, timely and authoritative information to students, educators, government representatives, the media, members of the research community and the general public.
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Build Back Better Coalition
A statewide coalition of public and private partner organizations and institutions, led by the North Carolina Biotechnology Center, received a Phase 2 award totaling nearly $25 million from the U.S. Economic Development Administration’s Build Back Better Regional Challenge. This award is strengthening North Carolina’s robust life sciences manufacturing workforce by funding the following programs:
- Workforce diversification
- Expanded training access and faculty recruitment
- Community engagement
