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UNC exploring a North Carolina-based gene therapy biomanufacturing foundry 

North Carolina is on the front line of scientific and engineering research on viral vectors for gene therapy. A potential convergent science collaboration may make the state a hub for both R&D and manufacturing.

Challenge

Gene therapy products (GTPs) are revolutionizing medicine, and biopharmaceutical manufacturing is at a crossroad. But as the demand grows for new technologies and process designs that can achieve advanced manufacturing of these new therapeutic modalities, so does the need for an expanded, well-trained workforce to establish and operate those processes.

The GTP market is experiencing explosive growth and, by 2050, GTPs will predominantly rely on viral vectors to deliver genes for fighting cancer, central nervous system disorders, cardiovascular and neuromuscular diseases, and global pandemics. With 60 to 80 million patients affected by these diseases per year worldwide, the human impact is enormous. Accordingly, the biomanufacturing of viral vectors is expected to create thousands of jobs and generate global revenues of up to $5.9 billion per year by 2030. Innovations in viral vector manufacturing can reduce the cost of gene therapies and make them accessible to larger numbers of patients in need.

Solution

The UNC Institute for Convergent Science (ICS) is bringing together the scientific and translational expertise of faculty at the UNC Gene Therapy Center with the biomanufacturing and engineering talent of faculty at NC State University and UNC-Chapel Hill to explore the potential to establish a Gene Therapy Biomanufacturing Foundry. Based in North Carolina, the biomanufacturing foundry could enable advanced manufacturing of GTPs and develop tailored curricula to train the biomanufacturing workforce.

This initiative combines expertise and resources across North Carolina and will create novel methods and technologies for product-agnostic purification and real-time monitoring in viral vector bioprocessing. To this end, the ICS brings together:

  • Expertise in bioprocessing and biosensing technology in biomedical engineering (UNC-Chapel Hill and NC State) and chemical/biomolecular engineering (NC State University).
  • State-of-the-art manufacturing facilities (simulated GMP) of the UNC Gene Therapy Center and NC State University’s Biomanufacturing Training and Education Center (BETC).
  • Workforce training resources at BTEC and Alamance Community College.

This project includes broad participation by North Carolina-based companies operating in the fields of AAV manufacturing (BridgeBio) and bio-separation (LigaTrap Technology and Fuji Silysia). It also has the endorsement of global companies that manufacture gene therapy vectors (Merck KGaA and Johnson & Johnson) or deliver bioprocessing tools (MilliporeSigma).

Impact

The biomanufacturing foundry will embody the role of university research in building new intellectual property, revenue streams, and North Carolina-focused industrial opportunities to produce cures to diseases that are difficult or impossible to treat.  Outcomes of research at the foundry will enhance the University’s ability to further develop and validate GTPs in-house, increasing the academic assets and driving increased revenue into the UNC System. The project will develop training curricula for North Carolina’s workforce, to be offered at NC State University’s BETC and Alamance Community College.

North Carolina is at the front line of scientific and engineering research on viral vectors for gene therapy and aims to become the hub of both R&D and manufacturing. The licensing revenue generated by the UNC system’s intellectual property in GTPs provides a revenue stream that supports innovation, economic development and workforce training. This maximizes the state’s investment in higher education and fulfills the role of the universities as economic development engines serving the people of North Carolina.