Life sciences handbook 2019

 In June 2019

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In recent years, North Carolina has emerged as a national and worldwide leader in the biotechnology and life-sciences sector. According to the North Carolina Biotechnology Center’s 2018 TEConomy report, the state’s pharmaceuticals sector is No. 3 in the nation, generating $56.4 billion in economic activity, supporting 132,507 jobs earning $9.6 billion in labor income, and generating $1.4 billion in state and local government revenue.

In the subcategory of biomanufacturing, North Carolina stands tall on a global scale. In 2018, at least 25 biomanufacturing companies were open for business in the state, directly employing 9,163 people. Agricultural feedstock and industrial biosciences generate $7.3 billion in economic activity and supports 14,061 jobs, according to the report.

Business North Carolina magazine profiles four companies in this robust sector: Glenmark Pharmaceuticals in Monroe, which makes a variety of fixed-dose pharmaceutical formulations; Humacyte Inc. in Durham, a local regenerative medicine startup that is creating human blood vessels using donor cells; Pairwise Plants of Durham, a company that harnesses the potential of genome editing to enhance the growth and sustainability of healthy food; and Thermo Fisher Scientific, a bioscience company that manufactures sterile injectables, tablets and capsules in its 1.5 million-square-foot facility in Greenville.

Agriculture Advances

Through gene editing, Pairwise Plants is carving out a niche in the growing ag-tech economy.

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Pairwise, a Durham-based gene editing and plant-technology startup, is leading the way in agriculture technology by using advanced tools to alter the DNA of plants, creating crops that grow year-round in any climate and produce better food.
By Teri Saylor
Imagine having fresh local blueberries in North Carolina year-round.
That’s the vision of Tom Adams, CEO of Pairwise, a Durham-based gene editing and plant-technology startup that focuses on engineering crops to extend their growing seasons and increase their availability.
“I love blueberries, and I dream of being able to get fresh, local blueberries every day,” he says.
The company has brought together leaders in agriculture and technology to develop new varieties of crops through gene editing.
Founded in March 2018 by scientists David Liu, J. Keith Joung and Feng Zhang, Pairwise established its headquarters in a 36,000-square-foot building on the Golden Belt campus in Durham. Pairwise also occupies 24,000 square feet of greenhouse space and 30,000 square feet of manufacturing space in Research Triangle Park.
“North Carolina, Durham and RTP are a great fit for us, and there is plenty of space for growth,” Adams says.
North Carolina is home to diverse agriculture with a variety of crops. It’s also an emerging technology hub in the life sciences and pharmaceutical industries, says Haven Baker, chief business officer for the company.
“Establishing our headquarters in Durham gives us access to a stellar talent pool from the Research Triangle Park and the state’s great university system,” he says.
According to the North Carolina Biotechnology Center, Pairwise adds to a growing agriculture technology cluster in Research Triangle Park, positioning the region to become an important player in the emerging industry.
Pairwise employs 67, but Adams hopes to have 90 employees by this August. Adams estimates half the company’s innovative plant scientists are from the area.
To do its work, Pairwise has licensed CRISPR, an enzyme capable of cutting strands of DNA, to make specific changes in crops that can’t be done with breeding, according to Adams.
“It is an exciting process, like using a pair of tweezers or scissors to very specifically modify RNA or DNA,” Baker says.
Pairwise also licensed a programmable base-editing technology pioneered by Liu that allows scientists to rewrite DNA.
Put simply, if CRISPR acts as scissors programmed to snip specific DNA sequences, then base editors are pencils with erasers, capable of directly changing one DNA letter into another.
“Using CRISPR and base editing, we now have the tools to engineer healthier foods and to make it easier for consumers to have access to a greater variety of healthy snacks,” Adams says.
Genetic engineering can also create crops that will adapt to climate change or grow year-round.
“Fifty or 60 years ago, blueberries were exclusively a Florida crop,” Adams says. “But thanks to breeding and technology, blueberries are migrating north. Today, South Carolina is the biggest producer of blueberries in the country.”
Though the company has been in business for just a short time, scientists are already busy working in the lab and starting plants in the greenhouse. They have a goal to start launching products through their precision-breeding program in five years.
“We are not talking about technology alone, but we want to create products consumers can benefit from and purchase in their neighborhood grocery store,” Adams says.

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Saving Lives

Humacyte perfects technology for growing blood vessels from donor cells.

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Humacyte’s lead product, Humacyl, is undergoing clinical trials for patients with renal failure, a longtime goal of the company. It is exploring using donor cells to create blood vessels for those who need them.
By Teri Saylor
Durham biotechnology firm Humacyte Inc. has spent more than a decade making a name for itself in regenerative medicine that enables scientists to grow bioengineered blood vessels. Now, the company, which has raised $480 million over the years, is looking to expand into other human tissues.
The company’s lead product, Humacyl, is undergoing clinical trials in patients with peripheral arterial disease and renal failure. Humacyte’s goal has been to create long-lasting access to veins or vein replacements for patients on dialysis. Engineered veins would prevent patients from having to use surrogate vessels from other parts of their body.
“Patients on dialysis must have good blood vessels in which needles are placed for the machine which cleans their blood,” Chief Operating Officer Heather Prichard says.
About 30 million American adults have chronic kidney disease, according to the National Kidney Foundation. Approximately 475,000 of these patients receive dialysis at least three times per week to replace kidney function.
In 2006, Humacyte was launched with a $150,000 research loan from the North Carolina Biotechnology Center. Founders were Laura Niklason, a former Duke University professor of anesthesia and biomedical engineering who now teaches at Yale University, and molecular biologist Juliana Blum. The company now has 130 employees. “Our growth is attributed to the fact that the science has come a long way, and the company is beginning to build toward commercial manufacturing,” says Prichard, who joined Humacyte in 2008.
Regenerative medicine usually relies on using a patient’s own cells to grow organs, and in cases where donor cells are used, rejection is a concern.
Humacyte’s processes use donor cells without the threat of rejection, according to Prichard. The vessels are created from donated human muscle cells placed on a small, scaffold-type structure. The tissues grow into a 3D DNA matrix that can be implanted into the patient. Clinical trials, which involve 450 patients worldwide, suggest the product has the potential to become a part of the body’s living tissue.
Humacyte’s product has not been approved by the U.S. Food and Drug Administration, but in 2017, it received one of the agency’s first Regenerative Medicine Advanced Therapy designations. This means the FDA will help expedite development of the technology for patients who need life-sustaining dialysis.
Plans call for seeking FDA approval for commercial applications next year, Prichard says. “If we are successful, we hope to expand over the next few years to meet market demand.”
Last year, the company secured a $150 million investment from Germany’s Fresenius Medical Care, the world’s largest dialysis company. That followed several funding rounds, including $75 million raised in March 2018 from 29 investors. Key funders include the California Institute for Regenerative Medicine, which has provided $24 million in grants and investments. Also, the U.S. Department of Defense signed a $3.4 million contract to use Humacyl to treat traumatic vascular injuries.
Recently, Humacyte moved into a building with 80,000 square feet of office, lab and manufacturing space. Plenty of growth opportunities exist, Prichard adds.
“Our technology platform can put the product into many areas,” she says. “We can use it for additional places in the body such as the esophagus and the trachea and ultimately use it to create organs.”

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Manufacturing Medicine

Glenmark Pharmaceuticals is making its mark in Union County.

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Global pharmaceutical company Glenmark opened its first manufacturing facility in the U.S. in Monroe just a few years ago. Specializing in products that treat dermatological and hormonal conditions as well as oncology drugs, Glenmark received FDA approval for its first North Carolina-manufactured drug last year.
By Teri Saylor
Glenmark Pharmaceuticals’ first U.S. manufacturing facility is conveniently located in Monroe, providing the company with a good economy, strong workforce and welcoming environment. The 50-year-old pharmaceutical company, headquartered in India, settled in Union County in September 2014, marking the first pharmaceutical manufacturing company to locate in the area in two decades.
Glenmark produces ingredients for generic drugs and has about 80 million prescriptions. This represents approximately 2% of the market share in the U.S., according to Robert Matsuk, president of Glenmark’s global and North American active pharmaceutical ingredients business.
The 100,000-square-foot manufacturing plant, located near the Charlotte-Monroe Executive Airport, employs about 160 people.
“Union County and the city of Monroe are great to work with, and it was important for us to be close to Charlotte,” Matsuk says. “We are pleased that the investment we’ve made in our facility will continue to create new, high-quality jobs in the Monroe community where we have a commitment to long-term growth and expansion.”
The publicly traded company was founded in Mumbai, India, in 1977 and launched its North American subsidiary in New Jersey in 2003. Last fiscal year, Glenmark reported annual revenue of $1.4 billion.
It operates 17 manufacturing facilities and five research and development centers worldwide with 800 scientists. Glenmark employs more than 12,000 people worldwide. Its North American headquarters and distribution centers are in New Jersey.
According to published reports, Monroe, Union County and North Carolina offered a combined $1 million in incentives when the manufacturing plant opened, which included a $625,500 discount on the building, a county economic-development grant of $340,000 and a state grant of $61,500 for community-college training for employees. Glenmark’s initial investment in Monroe was $17 million.
“We collaborate with South Piedmont Community College for training,” Matsuk says. “Often, we hire employees straight out of college, and while most of our senior management is from outside the region, a vast majority of our employees are local.”
Glenmark specializes in products that treat dermatological and hormonal conditions as well as oncology drugs. Typical customers for Glenmark’s generic-branded drugs are big pharma wholesalers and retail chains such as CVS and Walgreens.
A year ago, Glenmark received its first U.S. Food and Drug Administration approval to market its North Carolina-manufactured anti-malaria drug, which is a generic version of GlaxoSmithKline’s Malarone.
Last April, the company received FDA approval to market its generic version of Novo Nordisk’s Vagifem, a product designed to alleviate menopause symptoms.
The North Carolina Biotechnology Center’s 2018 TEConomy report shows that the state’s pharmaceutical sector is the nation’s third-largest, generating $56.4 billion in economic activity while supporting 132,507 jobs.
In Union County, Glenmark is doing its share to contribute to those numbers.
“Our investment in Monroe is a key priority for Glenmark, and contributing to the surrounding community through high-quality job creation and educational investments is a critical success factor as we expand our global manufacturing operations into the U.S.,” Matsuk said in a news release.

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Greenville Upgrades

Thermo Fisher Scientific’s plant is a boon for eastern North Carolina.

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A $74 million upgrade to Greenville’s 1.5 million-square-foot Thermo Fisher Scientific plant will increase the pharmaceutical manufacturer’s capacity through new equipment and technology.
By Teri Saylor
Thermo Fisher Scientific, one of the nation’s largest biotechnology products manufacturers, is expanding its capacity to produce prefilled syringes and vials thanks to a $74 million upgrade to its Greenville plant.
This expansion is part of a $150 million global investment in three fill-and-finish plants. It will allow the company to increase capacity through the purchase of new equipment and technology, according to Michelle Logan, senior director of operations.
Last August, Thermo Fisher completed its $7.2 billion acquisition of Patheon, the Durham-based company that formerly operated in the 1.5 million-square-foot facility alongside DSM Pharmaceuticals.
The combined organization delivers an end-to-end solution for clients, from initial drug formulation to clinical trials and then to commercial production, according to Mari Mansfield, a company spokeswoman.
It’s one of the world’s leading facilities for the manufacturing of aseptic, or sterilized, liquid fill, oral-dosage forms and lyophilized products. Lyophilization, also known as freeze-drying, allows materials to be shipped more efficiently and stored longer.
The investment won’t impact hiring, Mansfield adds, but she predicts growth in the future.
“We are now up to 1,500 employees at our Greenville location and are excited about this new investment,” she says. “We do foresee long-term growth here, and our plan is to drive talent acquisition over the next five-year window.”
Thermo Fisher employs 2,900 across the state. Worldwide, the company boasts 70,000 employees and more than $20 billion in annual revenue.
The Greenville plant manufactures 700 products and serves 400 customers, including some of the leading pharmaceutical and biotechnology companies, Mansfield says.
“We’ve worked on 48 of the top 100 selling medicines. We have launched 117 new drug approvals in the last decade, and we produce more than 20 billion solid doses and 250 million sterile doses a year,” she says.
Today, Thermo Fisher invests $215 million in payroll, temporary labor, capital expenditures and taxes in the state and spends $120 million with state vendors.
“Thermo Fisher is very successful here, and we have created a strong partnership with the state,” Logan says. “North Carolina, as a whole, is a desirable place to be, with access to talent and a diverse infrastructure. We have quality of life and economic stability.”
North Carolina also offers partnership opportunities with universities, community colleges and state agencies, which provide avenues for growth, development and jobs, she adds.
In 2016, North Carolina voters approved a $2 billion bond package to support statewide capital improvements, two-thirds of which will go to fund improvements in higher education, specifically STEM education, career readiness, medical sciences and business. Thermo Fisher is collaborating with the state in these efforts.
“During its time in North Carolina, Thermo Fisher has leveraged its partnerships to help support key development issues, including the Connect N.C. Bond Act, which will expand to include STEM programs on campuses across the state,” Mansfield says.
Logan, who has been involved in the company for most of the last 18 years, is excited to see growth continue in Greenville.
“We do a great job here. Greenville is a great place to live and fulfill our mission of producing products that are healthy, clean and safe,” she says. “The future is limitless.”

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