Executive Summary
Master of and Master of Science in Biomanufacturing
Biomanufacturing is the application of fundamental biotechnology and engineering principles to produce
human medicines, foods, fuels and novel materials. However commercial application of this knowledge
will not be successful without leaders also trained in safety, regulatory compliance and sound business
decisions. The Master of Biomanufacturing and Master of Science in Biomanufacturing
(both degrees will be designated BIOM) will bridge this intellectual gap and create the first
U.S. cross-disciplinary Professional Science Master’s degrees (PSM) in Biomanufacturing
integrating hands-on technical, scientific, research, and selected life science business and
project management skills.
BTEC currently does not offer a degree. Many undergraduate or post-baccalaureate
students who take BTEC courses have expressed interest in obtaining a graduate degree in
biomanufacturing. This is particularly attractive to engineering undergraduates who have
completed the biomanufacturing concentration courses at BTEC as a component of their
undergraduate degree in Chemical and Biomolecular Engineering. These CBE graduates
will now have the option to apply to and receive a graduate engineering degree in
biomanufacturing.
The BIOM is not a dual degree program – it is a unique cross-disciplinary degree. This degree will be
supported by a recently awarded 3-year $699,998 NSF DGE grant, State and industry resources and the
advanced academic laboratory and lecture courses of the new Golden LEAF Biomanufacturing Training
and Education Center (BTEC) located on the Centennial Campus of North Carolina State University
(NCSU).
The BIOM program will be offered collaboratively by faculty in three colleges (CALS, COE, COM) which
include the Departments of Microbiology; Food, Bioprocess and Nutritional Science, the Biotechnology
Program, the Biomanufacturing Training and Education Center (BTEC), the Chemical and Biomolecular
Engineering Department, and the College of Management’s Jenkins Graduate School of Management Life
Science MBA Program. All of these groups along with the NCSU Graduate School jointly submitted the
proposal to the National Science Foundation in November, 2009 and have contributed letters of support.
BIOM will offer both a non-thesis Master of Biomanufacturing (Option B) and a thesis Master of Science
in Biomanufacturing degree options. The curriculum is an integrated multidisciplinary program
consisting of lecture plus 8-week hands-on laboratory courses which are already established at BTEC for
training students in bench-scale, intermediate-scale (30 liter) and large-scale (300 liter) cGMP operations
using state-of-the-art industrial biomanufacturing equipment. The BIOM curriculum includes FDA
regulatory compliance combined with bioscience-focused MBA courses taught by the NCSU Jenkins
Graduate School of Management. Industry professionals from North Carolina and faculty from the
Colleges of Engineering, Agricultural and Life Sciences, and Management will teach graduate courses in
upstream fermentation, microbial biotechnology, downstream purification, protein formulation,
bioanalytical testing methods, FDA compliance, ethics, accounting, management of risk and technical
communication. Courses in professional skills, industrial internships, industry case studies, strategic and
ethical decision-making, project management and a research experience will be required. All graduate
courses to start the BIOM have already been approved with the exception of BEC 590 Industry Practicum
in Biomanufacturing, a new biomanufacturing industry case studies course.
This program will be administered at BTEC by Professors Michael C. Flickinger and BTEC Director Ruben
G. Carbonell (including an NSF funded Program Manager FTE) through the NCSU College of
Engineering. Professor Flickinger will serve as the Director of Graduate Program (DGP). Professor
Flickinger will coordinate the COE BIOM engineering PSM with Professor Paul Hamilton (Dept. of
Microbiology), Director of the CALS life science Masters of Microbial Biotechnology (MMB) PSM program
to avoid curriculum duplication and competition with local industry collaborators.
The BIOM will be
coordinated with other NCSU PSM programs by Dr. Lisbeth Borbye, Assistant Dean for Professional
Education, the Graduate School. The existing BTEC Industry Advisory Board will assist with curriculum
relevance, provide industry internships and feedback/metrics on BIOM graduate success.
BIOM Objectives:








Create the first cross-disciplinary advanced biomanufacturing + project management graduate
degree program in the U.S. leveraging the new BTEC facility;
Create both a non-thesis MR (Option B) and a MS thesis-option degree taught using the
biomanufacturing facilities at BTEC and including selected MBA courses;
Leverage NSF Division of Graduate Education funding recently awarded to BTEC which will
support this new degree program for the first 3 years. The initial full-time student enrollment
(years 1-3) will be determined by NSF support;
Graduate a total of ten full-time BIOM students in three years, 5 will graduate in year 2, and 5 the
third year (supported by the NSF grant), with emphasis on increasing participation of students
from underrepresented groups.
Establish sustainability of this program, and recruit an additional 5 or more full-time students
starting in year 3 that will not be supported by NSF funds and would graduate beginning in 2014
or 2015.
Educate, train, and mentor all students on how to integrate scientific, analytical, and hands-on
technical expertise in biomanufacturing with bioscience MBA business management, project
management, FDA regulatory compliance, communication and other professional skills;
Educate, train, and mentor all students on how to apply classroom and manufacturing scale
laboratory learning from the BTEC facility in real-life work environments through structured
industry-driven case studies, industry internships, and industry-focused research experiences.
Create a pathway to train biomanufacturing leaders and facility managers. Individual BIOM
graduate students who wish to become biomanufacturing facility managers will be encouraged to
pursue the Jenkins Graduate School of Management Life Science MBA Program offered by the
College of Management;
The creation of Science Master, and Professional Science Master Programs that emphasize
interdisciplinary science, engineering and business training, strong curriculum and performance guidance
from an industrial advisory board (IAB), as well as an industry-relevant research experiences are a key
part of the University of North Carolina’s strategic plan entitled “UNC Tomorrow”. Biomanufacturing is a
thriving industry in North Carolina. North Carolina ranks third nationwide for bioprocess manufacturing.
More than 50 companies manufacturing biologics, biopharmaceuticals and diagnostics operate here.
Biogen Idec, GlaxoSmithKline, Novozymes, Pfizer (formerly Wyeth), Pfizer Animal Health, and Talecris
operate some of the largest and most unique facilities in North Carolina. The North Carolina
Biotechnology Center’s strategic plan predicts creation of an additional 125,000 biomanufacturing-related
jobs in North Carolina by 2023.
BIOM is an industry-focused College of Engineering (COE) manufacturing degree which includes
advanced training in industrial equipment and facility design, project management, FDA quality by design
(QbD), and management of manufacturing operations as well as FDA regulatory compliance. This new
degree program will differ from the existing CALS life science Master of Microbial Biotechnology (MMB)
PSM program by emphasis on industrial biomanufacturing taught in the BTEC simulated GMP facilities
with hands-on laboratory courses, its emphasis on process engineering, FDA regulatory compliance, and
project management. The BEC 590 Industry Practicum in Biomanufacturing course to be created for
BIOM differs from the MB590 Case Studies in Microbial Biotechnology course currently required by the
MMB degree program. BEC 590 will only be taught once each year during the fall semester; in most
semesters focusing on in-house industry case studies using the BTEC facility. BEC 590 will focus on
engineering, operations management and business aspects related to industrial biomanufacturing and the
majority of students will be graduate engineers. BEC 590 will include concepts of professional skills
training, as does MB 590. Emphasis in BEC 590 will be on FDA cGMP regulations for biomanufacturing
facilities, quality by design (QbD) in biopharmaceutical processes, process validation, scale-up/scaledown, formulation, and project management for bulk biopharmaceutical manufacture.
The
biomanufacturing, regulatory compliance, architecture and engineering design companies that will
participate in BEC 590 will likely differ from those that contribute life science problems to MB 590
students. Member companies of the BTEC Industry Advisory Board (IAB) that have contributed lifescience focused industry case studies to the MB 590 students may also chose to contribute engineering
case studies problems to BIOM students using the BEC 590 course.
Creation of the BIOM PSM degrees is critically needed to address state skilled manpower needs, NC State
University, with funding from the Golden LEAF Foundation and the State of North Carolina, established
the $36 million Golden LEAF Biomanufacturing Training and Education Center (BTEC) in 2007. This
investment by Golden LEAF was strengthened by donation of over $14 million in new biomanufacturing
equipment from local biomanufacturing companies – a total investment of >$50 million
exclusively for teaching biomanufacturing. No other state in the United States has made
this scale of investment to create a simulated GMP biomanufacturing teaching facility
containing state-of-the-art industrial-scale equipment. BIOM will leverage this investment
to grant the first graduate biomanufacturing degrees in the U.S. As a unique cross-disciplinary
instructional center, BTEC provides education and hands-on training opportunities to develop skilled
professionals for the biomanufacturing industry and create the best-trained, most industry-focused
workforce possible. The 82,500 sq. ft. BTEC building contains approximately 63,000 sq. ft. of laboratory
training space, which simulates a biomanufacturing plant capable of producing, purifying, and
formulating biopharmaceutical products and packaging them in a sterile environment. Classroom and
laboratory space to support training and education occupies an additional 9,000 sq. ft., while the
remaining 13,000 sq. ft. is dedicated to administrative, process utilities and building support space. The
BTEC facility currently trains over 900 under graduate, graduate students from other disciplines, and
non-degree professionals as prospective and current employees per year. BTEC currently does not
offer a degree. Many undergraduate or post-baccalaureate students who take BTEC
courses have expressed interest in obtaining a graduate degree in biomanufacturing. This
is particularly attractive to engineering undergraduates who have completed the
biomanufacturing concentration courses at BTEC as a component of their undergraduate
degree in Chemical and Biomolecular Engineering. These CBE graduates will now have the
option to apply to and receive a graduate engineering degree in biomanufacturing.
BTEC is also part of a North Carolina statewide NCBioImpact consortium. NCBioImpact was created to
recruit, train and retain workers in the biomanufacturing industry. This public/private partnership is
comprised of the North Carolina Biotechnology Center (NCBC), the North Carolina Biotechnology
Industry Organization (NCBIO), BTEC, the Biomanufacturing Research Institute and Technology
Enterprise (BRITE) at North Carolina Central University, and the North Carolina Community College’s
BioNetwork. Through this vast network, BIOM students will have access to an array of state-of-the-art
educational resources, industry professionals, and internship or industry-focused research experiences
and develop networking skills for finding employment opportunities with local employers.
NC State has agreed to develop a sustainability plan beyond NSF grant support based on student tuition.
The BTEC IAB will provide curriculum guidance, contribute industry case studies for the BEC 590 course,
and will also be actively involved in program evaluation by providing the metrics of the success of BIOM
students once they are employed in the biomanufacturing workforce.