Golden LEAF Biomanufacturing Training and Education Center

The Golden LEAF Biomanufacturing Training and Education Center (BTEC) is a multidisciplinary instructional center at North Carolina State University

North Carolina State University

North Carolina State University at Raleigh is a public, coeducational, extensive research university located in Raleigh, North Carolina, United States. Commonly known as NC State, the university is part of the University of North Carolina system and is a land, sea, and space grant institution...

that provides education and training to develop skilled professionals for the biomanufacturing industry. Biomanufacturing refers to the use of living organisms or other biological material to produce commercially viable products. Examples include therapeutic proteins, monoclonal antibodies

Monoclonal antibodies

Monoclonal antibodies are monospecific antibodies that are the same because they are made by identical immune cells that are all clones of a unique parent cell....

, and vaccine

Vaccine

A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...

s for medical use; amino acids and enzymes for food manufacturing; and bio fuels and biochemicals for industrial applications. BTEC provides hands-on education and training in bioprocessing concepts and biomanufacturing methods that comply with cGMP

Good Manufacturing Practice

"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...

(current Good Manufacturing Practice), a set regulations published by the United States Food and Drug Administration (FDA)

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

.

BTEC reports administratively through the university's College of Engineering

North Carolina State University College of Engineering

North Carolina State University's College of Engineering is the flagship college of engineering in the state of North Carolina and the largest college in the University in terms of enrollment, followed by CHASS, with 9 core departments and 3 affiliated departments offering 18 bachelor's, 17...

and is guided by an advisory board made up of representatives from the biomanufacturing industry and other organizations interested in biotechnology and biomanufacturing.

In 2003, North Carolina's Golden LEAF Foundation

Golden LEAF Foundation

The Golden LEAF Foundation is a nonprofit corporation based in Rocky Mount, North Carolina in the United States, that was created in 1999 to receive half of the funds coming to North Carolina from the master settlement agreement with cigarette manufacturers. The foundation is now devoted to...

provided almost $39 million to build BTEC, as part of a larger grant to establish a statewide public-private partnership now called NCBioImpact. The state of North Carolina provided funds for process equipment and supports the operation of the facility. The NCBioImpact partnership now includes BTEC, BRITE (Biomanufacturing Research Institute and Technology Enterprise) at North Carolina Central University

North Carolina Central University

North Carolina Central University is a public historically black university in the University of North Carolina system, located in Durham, North Carolina, offering programs at the baccalaureate, master’s, professional and doctoral levels....

, North Carolina BioNetwork of the North Carolina Community College System

North Carolina Community College System

The North Carolina Community College System is a statewide network of fifty-eight public community colleges. Each college has a distinct governance system and policies. In total, the system enrolls over 800,000 students, and is the third largest community college system in the nation...

, NCBIO (North Carolina Biosciences Organization), the North Carolina Biotechnology Center

North Carolina Biotechnology Center

The North Carolina Biotechnology Center is a private, non-profit organization located in Research Triangle Park, North Carolina. Founded in 1984 by the North Carolina General Assembly, it was the first state-sponsored biotechnology initiative in the nation, merging the interests of the academic...

, and the Golden LEAF Foundation. It was created to provide workforce training and development for the biotechnology industry, thereby fostering the growth of this economic sector in the state. According to the North Carolina Biotechnology Center, North Carolina is home to 528 biotechnology companies that provide 57,000 jobs and $1.92 billion in taxes for state and local government. Employment in the industry has grown 4.1% from 2008 to 2010, when other industries shed thousands of jobs. In recent years some of the world's largest pharmaceutical companies, e.g. Novartis and Merck, have located and/or expanded manufacturing operations in North Carolina.

Facilities and equipment

BTEC opened in fall 2007 and was the first facility dedicated to biomanufacturing training. BTEC is 82,500 gross square feet and contains 63,000-gross square feet of laboratories, which range from small or bench scale to large-scale suites that simulate a biomanufacturing pilot plant capable of producing biopharmaceutical

Biopharmaceutical

Biopharmaceuticals are medical drugs produced using biotechnology. They include proteins , nucleic acids and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic...

products. Equipment in these spaces includes the following:

Bioreactors, glass and stainless steel (2L - 300L) and disposable (10L - 250L)
Automation systems with distributed control architecture
Downstream recovery and purification equipment, and
Analytical instrumentation

In addition, the BTEC facility is home to the North Carolina Community College System's BioNetwork Capstone Center, which operates an aseptic processing/filling suite and several bench-scale labs.

University programs

BTEC delivers undergraduate and graduate courses to North Carolina State University students. Academic programs include the following:

undergraduate certificate
undergraduate minor
post-baccalaureate certificate
graduate minor
a master's program offering two Professional Science Master's degrees, a Master of Science in Biomanufacturing (MS) and a Master of Biomanufacturing (MR)

Curriculum was created with extensive input from industry professionals, and most courses include substantial hands-on laboratory work. Most BTEC courses are offered in a half-semester (eight-week) format, which enables students to complete a series of courses in one academic year.

Job training

BTEC collaborates with industry partners to design, develop and deliver courses that provide professionals working for biomanufacturing companies, equipment vendors, or regulatory agencies with continuing education opportunities. Open-enrollment courses are offered throughout the year and are available to all interested parties. BTEC also regularly delivers courses customized to meet a client's specific needs for training.

BTEC provides biomanufacturing training specified in contracts of grants to provide training for government agencies. In 2007, the FDA

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

awarded BTEC a 5-year contract to develop and deliver biomanufacturing training for FDA inspectors. In 2010, BTEC received a grant for almost $900,000 from Biomedical Advanced Research and Development Authority

Biomedical Advanced Research and Development Authority

The Biomedical Advanced Research and Development Authority , within the Office of the Assistant Secretary for Preparedness and Response in the U.S...

(BARDA), part of the United States Department of Health and Human Services

United States Department of Health and Human Services

The United States Department of Health and Human Services is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America"...

. With funding from this grant, a team of instructors from BTEC, Duke University

Duke University

Duke University is a private research university located in Durham, North Carolina, United States. Founded by Methodists and Quakers in the present day town of Trinity in 1838, the school moved to Durham in 1892. In 1924, tobacco industrialist James B...

, and industry provide a three-week course on influenza vaccine manufacturing. Trainees were selected by institutions participating in a U.S. government-sponsored program to build vaccine production capacity among countries with developing economies. Countries represented included Egypt, India, Indonesia, Mexico, Romania, Serbia, Russia, South Korea, Thailand, and Vietnam.

Bioprocess and analytical services

When laboratories are not being used for training, BTEC uses them to perform a variety of services for scientists from industry, government, and academia. Projects involve technology development, process improvement/scale-up, analytical testing, and preparation of material for preclinical studies. These services allow scientists to advance their research projects toward commercialization. In turn, these advancements stimulate the North Carolina economy.

Location

BTEC is located on the Centennial Campus

North Carolina State University Centennial Campus

Centennial Campus is a research park and educational campus owned and operated by North Carolina State University in Raleigh, North Carolina, USA. Composed of two locations, the property provides office and lab space for corporate, governmental and not-for-profit entities, in addition to providing...

of North Carolina State University

North Carolina State University

in Raleigh, North Carolina

North Carolina

North Carolina is a state located in the southeastern United States. The state borders South Carolina and Georgia to the south, Tennessee to the west and Virginia to the north. North Carolina contains 100 counties. Its capital is Raleigh, and its largest city is Charlotte...

, USA. The campus is approximately 15 miles east of Research Triangle Park

Research Triangle Park

The Research Triangle Park is a research park in the United States. It is located near Durham, Raleigh, and Chapel Hill, in the Research Triangle region of North Carolina...

and Raleigh-Durham International Airport

Raleigh-Durham International Airport

Raleigh-Durham International Airport is a public international airport located 4.5 miles northeast of the town of Morrisville in suburban Wake County, North Carolina, United States. The airport covers and operates three runways, providing direct service to 40 domestic and international...

External links

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