Biotechnology Round Table March 2013

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 Minding their business

Biotechnology is changing North Carolina manufacturing, including what it makes, what it needs and how it is seen.

North Carolina has always been known for manufacturing. But in addition to bedroom suites and linen, its workers are now making vaccines and pharmaceuticals. In 2011, biomanufacturing employed more than 18,000 people at more than 50 companies in the state. The industry is strong and has a bright future, growing even through the recession. But with this growth comes needs — from resources to talent. A panel of experts recently gathered to discuss how biomanufacturing fits into the state’s economy and what is needed to nurture its work, which touches almost everyone who receives medical care. Participating were John Balchunas, director of workforce development at Research Triangle Park-based North Carolina Biotechnology Center; William Bullock, vice president of bioscience industrial development at North Carolina Biotechnology Center; Bruce Kaylos, program manager for Research Triangle Park-based NCBIO Biotech Manufacturers Forum; James Rebbeor, principal process development scientist at Barcelona, Spain-based Grifols Inc.’s Raleigh office; Jonathan Sexton, associate professor in N.C. Central University’s Department of Pharmaceutical Sciences and faculty member at the Biomanufacturing Research Institute and Technology Enterprise; and Michael Wanner, executive vice president of operations for Research Triangle Park-based Medicago USA Inc., a subsidiary of Quebec, Canada-based Medicago Inc. The North Carolina Biotechnology Center sponsored and hosted the discussion, and its president and CEO, E. Norris Tolson, was the moderator. The following transcript has been edited for brevity and clarity.

What’s the status of biomanufacturing in North Carolina?

Kaylos: Over the last 10 or 12 years, biomanufacturing companies in the state have matured. They use diverse technologies — nanotechnology, for example, is becoming a part of biotechnology — that need a high level of expertise. How we accommodate new technology is the next challenge to staying at the top of the industry.

Wanner: I see a stronger industry today compared with two years ago when Medicago came to the state. Our sector of the economy is rebounding, and it is an encouraging environment right now.

Sexton: We see, especially from some of our industrial partners, a changing landscape in terms of what technologies need to be reflected in the workforce. We are adapting our curriculum to meet that need.

What suggestions would you share with the governor’s new economic adviser to grow biomanufacturing in the state?

Rebbeor: State government needs to make a visible commitment to biotechnology and declare North Carolina the center of biomanufacturing excellence in North America. It needs financial contributions and a commitment from every resource and department in Raleigh, whether it’s education or infrastructure.

Wanner: Money must be invested in biomanufacturing. If the state has the vision to see where the economy is moving in terms of better jobs, it should certainly support biotechnology. The state has made steps in that direction. Even at a local level, when we built our building, the county was aggressive and cooperative about getting it done. You have to have a mechanism to make this happen, and you need to sustain it.

Tolson: North Carolina says it has the fastest-growing biotech cluster in the U.S., and it has been for a while. We strongly believe that at the biotechnology center because North Carolina consistently has invested in life-science development, and we’ve got the growth to show for it. It’s not an accident that we got to be No. 3 in the country in biotechnology.

What is the potential for contract manufacturing in North Carolina?

Kaylos: As time goes on, it will be more difficult for startup biotechnology companies to do everything in-house. Research dollars go further if companies can subscribe to services, and there are several companies in the state that provide them. Does it make sense while talking about infrastructure possibilities to suggest a deal between companies? I think so, and it’s already happening. Research Triangle Park neighbors Biogen Idec and Eisai have come together, matching manufacturing capacity and a product. Now both companies are benefiting without having to put more bricks and mortar in the ground. We’ve got to show we’re willing to share like that to keep costs down and efficiency up. 

Does the manufacturing of biosimilars — made from cellular material, they are biotechnology’s equivalent to generic drugs, though much harder to produce — offer an opportunity for North Carolina?

Bullock: There’s an opportunity to expand the market for biologics manufacturing in North Carolina. It could be a good thing because you have an enhanced focus on cost, yet we still have the same requirements for quality and an educated workforce.

Wanner: Medicago has biosimilars in its product pipeline so we expect to be making them here. That would definitely be an expansion of our product portfolio. But the regulatory side of biosimilars needs to be clearer so that we know what it will cost to get them to market.

Kaylos: The university and community-college system will need to help companies navigate regulatory complexities. The Biotechnology and Training Education Center is working on a fifth round of training for U.S Food and Drug Administration folks because it’s a great environment in which to learn. The same will hold true for developing new industry because many of those folks come from universities and are not familiar with running the regulatory gauntlet. If you have knowledgeable people helping them refine their process and helping them present a case to the FDA, you can expedite development compared with folks traversing their own learning curve.

What kind of resources do biomanufacturers need to be successful in North Carolina?

Sexton: From a workforce perspective, companies need access to talent. That’s one reason behind NCBioImpact, which is a partnership between the university system and the community-college system that helps schools stay informed of biomanufacturing needs and respond appropriately. Community colleges can create programs for workers to move into manufacturing whereas universities can create programs for engineers. Either way, students need realistic projects that provide experience to be successful in the industry. Typical bachelor’s degree and training programs are heavy on theory and light on hands-on work. Our students spend 18 hours each week during their senior year on independent hypothesis-driven projects. For example, we have partnerships with companies, such as Biogen Idec, where a master’s degree student works for a little while and brings the seed of a problem back to the university. We elaborate on it and hopefully deliver something valuable back to the company. That framework can be used from high schools to Ph.D. programs. It prepares students to be immediately effective in the workplace after graduation, many times at the company that was involved in their project.

Bullock: There are infrastructure needs as well, not the least of which are water supplies and wastewater-treatment capabilities. If we can get out in front of these and match unique resources and infrastructure with the state’s world-class training initiative, which can be customized to particular businesses, we will have a leg up on the competition in terms of recruiting new biotechnology companies.

Rebbeor: Infrastructure is a constant constraint to developing products or scaling up manufacturing. Water supplies are important to us. Electricity is a big deal, too, because power outages have a large impact on our manufacturing. We are growing and anticipate those needs to continue with the expansion at our Clayton manufacturing plant. Educational institutions provide resources for new companies but so do existing companies. I know exactly when a new company is coming because my employees leave for positions there. The intellectual piece that universities can provide is critical especially for smaller or newer companies that typically don’t have many resources.

Wanner: Medicago needed that exact situation to ramp up from zero to 75 employees almost overnight. Knowing that experienced people were here to fill key roles helped bring the company to North Carolina and achieve its initial goals quickly. But there are positions that are currently underserved, such as mechanical, quality assurance and quality control. These are not the sexiest positions, but they are needed in every company. They are good jobs that pay well.

Balchunas: Biomanufacturing is not like information technology or health care where job requirements demand credentials and degrees. Biomanufacturing jobs require experience. A degree is an entry point to a biomanufacturing career, but growth is largely based on experience. The act of hiring employees away from existing companies helped drive the creation of NCBioImpact, which aims, in part, to make hiring easier by increasing the number of candidates. You’re never going to stop companies from raiding each other because a new company’s most experienced and capable employees will almost always come from an established company. The community colleges’ ability to do custom training is important too. They are the ones brokering those relationships with the companies, and that’s one thing that sets this state apart from others. An additional strength is its willingness to collaborate. Industry is always at the table to talk about its needs with universities and community colleges. Getting one big company there — let alone all of them, especially competitors — is rare.

Kaylos: As product lines diversify, companies won’t always be able to wait four years, or even two years, for someone with a degree. They are going to need workers with a blend of customized training and on-the-job experience. During the recession, universities did a great job of understanding that it’s not all about four-year degrees. They are combining specialty courses to form minors and master’s degree programs. We need more of that moving forward. There is an opportunity on the Ph.D. level to identify and solve key theoretical problems and undertake sponsored research and activities at centers of expertise. BTEC and N.C. Central University’s Biomanufacturing Research Institute and Technology Enterprise are working on this, and it’s key to bringing new companies to the state. If universities and community colleges are the fuel injectors for the engine of the economy, you can turn around and say to a prospective company that we’ve got a group that works on these types of problems — let’s put the two of you together and solve your challenges.

How can the benefits of biomanufacturing be best shared with high-school students, college students and communities?

Sexton: In addition to bringing students on-site, companies and universities have to take their message of available jobs and exciting work all the way from high schools to elementary schools. One of the most amazing things I’ve seen at a plant is a water-for-injection system, which prepares water for biomanufacturing processes. Its sheer size and complexity can excite and inspire students at any level, and that can help us grow our own workforce.

Wanner: Medicago is open about what it does and hosts many tours. We had former Gov. Beverly Perdue’s grandson come through on a tour, and he seemed pretty wide-eyed. I think you’ve got to put that out there and let the kids see what’s available for their future.

Tolson: In many places around North Carolina, science is a dirty word and kids are scared of it. I’m involved in a program that brings teachers into manufacturing settings for three-week externships. They go back to the classroom and explain real-life science to students.

Rebbeor: I presented Grifols’ Making Science Make Sense program to third-graders in Clayton. I did simple, fun experiments such as thin-layer chromatography. They didn’t understand what it was until I told them, but they thought how the colors separated was cool. For the company, it was wonderful that these children went home and said, “I met a guy from Grifols today, and he did something cool.” It made science practical, understandable and enjoyable. That’s critical and easy to do, but it takes commitment, enthusiasm and leadership from communities and companies.

Balchunas: It’s key that biomanufacturing is an attractive career option to high-school students and their parents, who may know nothing about it or have negative connotations about manufacturing in general. To the Clayton community, Grifols’ manufacturing plant there looks like any other. They need to know about the great things going on inside those walls.

What are some biomanufacturing advances taking place in the state that will get people excited?

Wanner: Medicago uses a unique process to make proteins and vaccines with the help of tobacco plants. They are efficient tools to make vaccines rapidly and less expensively, and that can change how people are vaccinated. I’ll give you an example of the rabies vaccine. People who travel overseas, especially to India or the Far East, are advised to get the vaccination because the incidence rate is higher in those parts of the world. By lowering the cost of the vaccine, which currently runs about $1,000 for each person vaccinated, more people would get it. The military also would be interested in a less expensive rabies vaccine for its troops.

Rebbeor: We are currently part of a clinical trial that’s using an aerosolized protein to treat cystic fibrosis. That’s the first time Grifols has aerosolized any of its treatments for use with an inhaler and a nebulizer. Previously, only intravenous infusions were used, which have limitations when treating younger, chronically sick or older populations. There have been great results with it, and we hope to apply what has been learned to some of our other products. There is the constant driver of patients who have needs to meet. Technology and goodwill have come together to meet those needs, and I am proud that we can enable that.

Sexton: When students visit, I show them simple things, such as centrifuges, which they’ve seen on the television series CSI and to them look like fun. If we can convey that what we do really is fun, they may want to do it as a career. They email me afterward, as do their parents, from the far reaches of North Carolina to say thanks. They are so excited and appreciative that they go home with a positive attitude that can end up changing their lives. Enabling our kids to do that is a powerful thing.

Tolson: We’re really talking about enlarging opportunities for life sciences in North Carolina: The opportunity to grow not only the state but also young individuals who are looking for an education and a career.

This article originally appeared in the March 2013 issue of Business North Carolina magazine.