To jump-start growth in the natural biotechnology sector, the North Carolina Biotechn...
The State of Biomanufacturing
Drive past a pond or lake in North Carolina in the summertime, and it will likely be lush with Lemna, a small, bright-green plant that lives on the water’s surface and grows so fast that it might well be considered the aquatic equivalent of kudzu. Lemna is better known by its common name, duckweed. But whatever you call it, don’t call it pond scum, or you’ll risk offending the people who revere the plant for its potential ability to produce life-enhancing medicines for the treatment of cancer, hepatitis, blocked arteries, rheumatoid arthritis and other afflictions.
Those people are namely the more than 50 employees of Biolex Inc., a biotechnology company in Pittsboro that genetically engineers duckweed to make protein-based medicines faster, cheaper and easier.
Duckweed is the fastest-growing plant known, reproduces easily, readily accepts new genes, and is capable of producing complex proteins that bacteria and yeast can’t easily make or that mammalian cells can make but only at great cost over a long period of time. These and other traits make duckweed an ideal production system for a wide range of recombinant proteins, including Biolex’s own and those developed by its partners and clients.
Another innovative contract manufacturer of therapeutic proteins is Durham-based KBI BioPharma. KBI uses conventional “stirred-tank” bioreactors to make proteins in microbial and mammalian cells but is also developing a more efficient system that uses a patented bioreactor technology called the Centrifugal Bioreactor (CBR). The CBR allows cells to be immobilized at very high densities without the use of membranes or other solid support or retention devices. The technology promises to give KBI’s customers more uniform product at a lower cost.
In addition to being innovators in the same business, Biolex and KBI share another common thread: early in their development, each company received critical assistance from the North Carolina Biotechnology Center. Biolex received a $100,000 Small Business Research Award from the Biotechnology Center in 2001 to demonstrate the production of alpha-interferon in duckweed. Also, through an earlier Institutional Development Grant to North Carolina State University, the Biotechnology Center helped NCSU recruit Dr. Anne-Marie Stomp, the plant molecular biologist who later launched Biolex. Meanwhile, KBI was recruited to North Carolina with the help of a $1 million loan and other assistance from the Biotechnology Center in 2003.
Why the focus on biomanufacturing? Because biomanufacturing – whether it be the production of drugs, vaccines, enzymes, amino acids or other biological products – is a fast-growing sector of biotechnology that brings high-paying manufacturing jobs to a state that is losing many of its traditional manufacturing jobs.
With about 50 companies and 20,000 employees engaged in biomanufacturing and the related manufacture of pharmaceuticals, diagnostics and medical devices, North Carolina already is a leader in this industry. Bringing even more of these companies and jobs to the state is one of the immediate priorities of New Jobs Across North Carolina: A Strategic Plan for Growing the Economy Statewide through Biotechnology, commissioned by Governor Mike Easley and developed by the Biotechnology Center.
Several initiatives recommended by the strategic plan are already under way. The Biotechnology Center and the N.C. Department of Commerce are implementing a new Retention, Expansion and Attraction Plan (REAP) to bring new biomanufacturing plants to North Carolina and to keep and grow the ones already here. The General Assembly has set up, but not yet funded, the N.C. Life Sciences Revenue Bond Authority, which would provide government-backed loan guarantees to help finance the construction of biomanufacturing plants. And Golden LEAF has invested $60 million of the state’s federal tobacco-settlement money in a new statewide program to train workers for biomanufacturing and pharmaceutical manufacturing jobs.
North Carolina State University in Raleigh will use its portion of the Golden LEAF money to build and equip a $36 million Biomanufacturing Training and Education Center (BTEC) scheduled to open in January 2007. Plans call for a 100,000-square-foot plant that will provide hands-on experience in a pilot scale, Good Manufacturing Practices (GMP) environment similar to an industrial setting. North Carolina Central University in Durham will receive $19.1 million for the Biomanufacturing Research Institute and Technology Enterprise (BRITE) to open in January 2007. BRITE will include a 65,000-square-foot research laboratory and classroom facility that will conduct research, teach and train at all levels in biotechnology and biomanufacturing. The North Carolina Community College System will receive $9.4 million for BioNetwork, a network of six centers statewide that will train workers in bioprocessing, pharmaceuticals and bio-agriculture and feed students into the BTEC and BRITE programs for additional training.
The training program is being implemented by the North Carolina Biomanufacturing and Pharmaceutical Training Consortium, a partnership of the University of North Carolina System, the N.C. Community College System, biomanufacturing companies, and the Biotechnology Center. The program will address training across all the relevant scientific, technical and engineering disciplines at all levels from Certificate or Associate Degree to Ph.D. The goal is to train 2,000 to 3,000 employees each year.
In addition to this training initiative, the Biotechnology Center has worked with industry and the North Carolina Community College System to develop the BioWork© course for training entry level bioprocess technicians in bioprocess, pharmaceutical, and chemical manufacturing.
“We’re determined that North Carolina will have the world’s best-trained workforce for biomanufacturing,” says Dr. Leslie Alexandre, president and CEO of the Biotechnology Center.
The state’s company-recruitment and workforce-training initiatives, coupled with strong research universities and a well-developed infrastructure for building and servicing biomanufacturing facilities, have put North Carolina on most companies’ “short list” of potential locations for new or expanded biomanufacturing plants.
KBI BioPharma, for example, chose North Carolina over six other states because of its supporting infrastructure for the biosciences, including the Biotechnology Center, excellent research universities and community colleges, specialized construction and engineering companies, available workers, and extensive workforce training programs, in addition to its high quality of life. “None of the other six (states) measured up when all of these factors were considered,” said Anthony Laughrey, president and CEO of KBI.
In recent years three other major biopharmaceutical manufacturers – Diosynth RTP, Biogen Idec and Merck & Co. – have committed to North Carolina, representing thousands of direct and indirect jobs and capital investments totaling hundreds of millions of dollars. Other biomanufacturing plants with established operations in North Carolina have expanded. They include Wyeth Vaccines, which operates one of the world’s largest vaccine facilities in Sanford, and Talecris Biotherapeutics (formerly Bayer), which operates the world’s largest blood-fractionation plant in Clayton. Several new biomanufacturing plants are also coming online in North Carolina. In 2004, Embrex dedicated a poultry-vaccine plant in Laurinburg and AlphaVax announced plans to build a human-vaccine plant in Durham.
North Carolina Biotechnology Center
15 T.W. Alexander Drive
Research Triangle Park, NC 27709
(919) 541-9366, www.ncbiotech.org