Abzena Plans $213M, 325-Employee NC Biopharmaceutical Manufacturing Site

Abzena logo
.

Abzena, a global British contract development and manufacturing organization (CDMO), has announced a $213 million plan to join the fast-growing North Carolina biomanufacturing ecosystem.

The privately held manufacturer of cell-based biologics for academic research labs and pharmaceutical companies said today it plans to build a new factory in the Lee County city of Sanford, creating 325 new jobs paying an average of more than $63,300 a year.

CDMO refers to companies offering services to pharmaceutical companies such as cell-line and process development, stability testing, the development and manufacturing of clinical-trial drugs as well as commercial drug manufacturing. Other high-profile CDMOs in North Carolina include FUJIFILM Diosynth Biotechnologies and Alcami Corp., both in Morrisville, Thermo Fisher Scientific in Greenville, Tergus Pharma and KBI Biopharma, both in Durham, Sterling Pharma USA in Cary, Cambrex Corp. in High Point and Raybow USA in Brevard.

Bioreactor at an existing Abzena facility
Small bioreactor at an existing Abzena facility. -- Abzena photos

Abzena said the North Carolina facility will be its sixth site, adding to its existing headquarters in Cambridge, England and facilities in San Diego and Bristol, Pennsylvania. 

“Abzena recognized North Carolina as a leader in biotechnology and knew this was the right place to develop and manufacture new medicines and grow their business,” said Governor Roy Cooper in a news release announcing the project.

Abzena chose to locate the new facility in North Carolina after also considering Philadelphia, Austin, Tulsa, Trenton, Greenville S.C., and San Diego.

The company said the North Carolina facility is a response to customer demand across a wide range of therapeutic areas. It said the new cGMP site will primarily make mammalian biologics for customers involved in Phase 3 clinical trials and those already involved in commercial sales.

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the U.S. Food and Drug Administration. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

In an earlier statement Abzena said the site “will be equipped to handle existing and new advances in manufacturing, such as continuous manufacturing and perfusion, with manufacturing commencing in mid-2022.” Perfusion is a manufacturing technique for increasing the output of cells in a bioreactor.

Biologics are products derived from living organisms through the process called biomanufacturing. Biologic drugs such as vaccines and anti-diabetes therapies are relatively large, complex molecules that are difficult to manufacture compared to chemically derived compounds typically referred to as “small molecules.”

Biomanufacturing is a multi-step process typically involving mammalian cell culture or microbial fermentation. Most recombinant protein pharmaceuticals are produced in mammalian cells, though many are also produced in microbial cells such as bacteria and yeast.

The first biologic product was Eli Lilly and Company's Humulin, the first human insulin for diabetes treatment, created using recombinant DNA technology. It was approved by the U.S. Food and Drug Administration in 1982. Today, Humulin and the human insulin produced by Novo Nordisk in North Carolina are still among the world’s most important biologics. Significantly, Lilly is currently building a pharmaceutical manufacturing facility in North Carolina’s Research Triangle Park.

CEO Jonathan Goldman
CEO Jonathan Goldman.

In fact, North Carolina has become a global leader in biologics development, including cell and gene therapies. The state has developed an ecosystem that includes dynamic academic institutions, a uniquely trained workforce and a business climate that has proven especially attractive to life sciences and technology companies.

"North Carolina's global leadership in biomanufacturing makes our state a natural fit for Abzena,” said Katie Stember, Ph.D., associate director of life science economic development at the North Carolina Biotechnology Center. NCBiotech helped provide technical support for Abzena’s recruitment to the state.

“This proposed Sanford CDMO facility will increase capacity for Phase 3 clinical trials and commercial manufacturing, providing key resources to enable companies in North Carolina and around the world to produce a wide range of products” explained Stember.

Sanford is also home to two other pharmaceutical facilites that brought major announcements recently – Pfizer and Audentes.

President Kimball Hall
President and COO Kimball Hall

Jonathan Goldman, M.D., CEO of Abzena, said, “We are delighted to support our partners and the patients they serve with this investment in cGMP biologics manufacturing. This builds on the successful launch of our second cGMP facility in San Diego in 2020. We are pleased to provide integrated asset development with a full suite of in-house services from discovery through clinical and commercial phases without the need for technology transfer.”

Kimball Hall, president and COO added, “The expansion in manufacturing capacity allows us to scale with our expanding customer needs. Our team is very experienced in high-quality clinical and commercial manufacturing of mammalian drug substance. We have used this experience to incorporate the most technologically advanced solutions in the design of the new site and are excited to welcome existing and new partners to work with us.”

Abzena will receive $7.7 million in Job Development Investment Grants from the state, contingent upon the company meeting investment and employment benchmarks. It's also in line for $632,000 in community college workforce training support and some $11.5 million in support from Lee County and the city of Sanford. The project is expected to result in $1.6 billion in gross domestic product for the state, providing $45.3 million in net state revenue over the first 12 years, through 2033.

“Innovative companies set a high bar for excellence, and with today’s decision, North Carolina once again meets and exceeds those standards,” said North Carolina Commerce Secretary Machelle Baker Sanders. “We welcome Abzena to the state’s growing life science industry cluster. As a former executive in this industry myself, it’s great to see how North Carolina is leading the way in the product lifecycle for new medicines that will improve and save lives.”

Partnering with NCBiotech and the North Carolina Department of Commerce and the Economic Development Partnership of N.C. on this recruitment project were the North Carolina General Assembly, the North Carolina Community College System,, the Office of Senator Thom Tillis, Duke Energy, the City of Sanford, Lee County, and the Sanford Area Growth Alliance.

For questions or more information, contact:
Jim Shamp
Director of Public Relations

Corporate Communications

919-549-8889 | jim_shamp@ncbiotech.org

Tue, 04/13/2021 - 13:00