INCREASING PRODUCTION.

• Position: ROUND TABLE: LIFE SCIENCES

North Carolina's dedicated effort to the biotechnology industry stretches back almost 40 years, before the idea was even a twinkle in most states' eyes. Since then, it has embraced the industry's many sectors, including biomanufacturing. The industry continues to produce a seemingly continuous supply of announcements, including startups, expansions, investments and jobs. While a solid foundation of support is established, more is needed to sustain the industry and its benefits. Business North Carolina magazine and N.C. Biotechnology Center recently gathered a panel of biotech experts and leaders to frame biomanufacturing's past, present and future.

BTEC, Eli Lilly, NCBIO, N.C. Biotechnology Center, Smith Anderson and Seqirus sponsored the discussion at N.C. Biotechnology Center, which was moderated by Business North Carolina Publisher Ben Kinney. It was edited for brevity and clarity.

Photography by Bryan Regan

WHAT IS THE CURRENT STATE OF NORTH CAROLINA BIOMANUFACTURING?

EDGETON: North Carolina welcomed 34 life-sciences companies last year. They invested almost $4 billion and announced about 4,000 jobs. We currently have about 30 active projects. We've done really well in recent years, and there's no reason why that won't continue.

The industry's footprint is spreading. Drugmaker Eli Lilly, for example, recently announced it's building a $1 billion factory, which will employ about 600 people, in the Charlotte suburb of Concord. We'll see more investments and innovations in the Charlotte region, which is welcoming two medical schools and has access to plenty of capital. Every community that we talk to is doing something within the industry. Much of that is driven by post-pandemic activities. We have the opportunity for a significant grant through the federal Build Back Better Challenge Grant. We coordinated the application for 28 peers statewide, and we won $500,000 in Phase I. We submitted Phase II on March 15, and we hope to hear its result in mid-September. The state will see about $70 million, if it comes through. Most of that money will be used to diversify the industry's workforce and share its wealth and experience with communities that haven't experienced either. Workforce is the key to unlocking future growth in biomanufacturing. We're excited. It wouldn't happen without great partnerships.

GUNTER: It's an exciting time. We've seen tremendous growth. Supply chain and talent are NCBIO's manufacturing members' biggest concerns. They want to ensure there is an adequate supply of skilled workers as they expand in North Carolina. We want to help innovative companies, too. NCBIO represents the industry when it comes to legislative policies that make North Carolina a good place for companies to form and grow. We've had recent success at the General Assembly. The Life-Sciences Caucus is interested in what it can do to help the industry. Its members helped adjust some regulatory items last year. We also had an appropriations win when the General Assembly added recurring dollars to the One North Carolina Small Business Program, which will match federal funding awarded to companies for innovative research. We're always looking for ways to bring more capital to the state. We have biomanufacturers moving to North Carolina. Companies are working from product inception through the start of manufacturing. A large group of companies are moving into the commercialization stage, bringing products to the market. In the past, those companies may have sold that technology to a larger company.

ROBERTSON: Fujifilm Diosynth Biotechnologies is growing tremendously. It has acquired several sites since I joined the company four years ago. It is building a large facility for mammalian cell culture in Holly Springs that will create about 475 jobs over the next five years. A nearly 32,000-square-foot expansion was recently completed at our Research Triangle Park facility. It expands downstream capability and adds a receiving warehouse, which was something missing from the site for some time. And soon we'll break ground on an 83,000-square-foot expansion to our BioProcess Innovation Center, which is at RTR too. It will almost double capacity and add about 150 jobs by 2024. Growing demand for process characterization, quality control services, and analytical and process development put us in a place where we need to expand. The company also recently acquired a cell therapy facility in California and is establishing a new process development and manufacturing facility for viral vectors and advanced therapies in Boston.

HORNER: It has been a busy time for Seqirus. We're improving our process and yield, expanding capacity to match growing demand, especially for influenza vaccines, which is an effect of the COVID-19 pandemic. CDC requested more flu vaccines during the pandemic in hopes of keeping more people out of hospitals. We're developing an sa-MRNA flu vaccine, which is similar to the approach used to create the COVID-19 vaccines, in parallel with extending the use of our cell-based flu vaccine. The supply chain has been a challenge over the past 12 to 18 months, as it has been for many companies and individuals. There's not enough of some things that we need. So, it's constant conversations with suppliers, making sure they know when we need materials and confirming that they can deliver them.

MIKHAIL: COVID-19 did not impact us negatively. We doubled our size in the United States and tripled our size overseas in one year. We have about 700 employees, and we're expecting to grow to 1,000 during the first quarter of next year. Our contract development and manufacturing business has seen growing demand. Gene-therapy manufacturing is in demand. We recently opened a more than 380,000-square-foot commercial factory overseas, where most of our manufacturing is located. Our process development is in North Carolina. We plan to open a U.S.-based origin facility and companion CDMO factory. We're pushing many gene-therapy programs through the clinic, including ones...