btec_annual_report_2010

Golden LEAF Biomanufacturing Training and Education Center

2010Annual Report

2 | Golden LEAF Biomanufacturing Training and Education Center

All of us at the Golden LEAF Biomanufacturing Training and Education Center (BTEC) are pleased to present this annual report, covering the period from fall 2009 through summer 2010.

This has been a strong period of growth for BTEC. We have seen growth in our undergraduate enroll-ment, and we have introduced new graduate courses that will culminate in a graduate certificate and master’s degrees in biomanufacturing. Of particular note was the development of “boot camps” that were held in the summer of 2010 to provide hands-on training to community college students on BTEC’s large-scale bioprocessing equipment. We have also seen a significant increase in the number of incumbent workers taking training courses at our facility, as well as a rise in the number of corpora-tions and other groups that come to us seeking help in bioprocess development and other services.

Even though the 2009-2010 fiscal year brought additional budget cuts from the state, we were successful in regaining some of these resources through our industrial short courses and process services activi-ties. This is a trend that is likely to continue through the 2010-2011 fiscal year.

In cooperation with our major partners in NCBioImpact, we continue to serve the Department of Commerce and other agencies in the state interested in economic growth by helping to highlight the state’s capabilities for unique education and training opportunities for a well-educated workforce in biomanufacturing. The unique facilities and curriculum provided by BTEC continue to be a great inducement for new industries considering coming to the state, as well as a tool for retaining companies currently in the state.

Significant national and international partnerships with agencies such as the Food and Drug Admin-istration (FDA), the Society of Biological Engineers (SBE), the Alsace BioValley in France, and many others, are helping us with our overarching goal to become the leading biomanufacturing training and education center in the nation and the world.

It is impossible to capture all of our activities and capabilities in a short report such as this, so we encourage you to visit our website (www.btec.ncsu.edu) to obtain additional information. We welcome your telephone calls and visits to our facilities. We look forward to discussing with you the many ways that BTEC can be of service to students, industry and the state. We are always looking for new partners and new activities to help expand our portfolio of services.

Ruben G. Carbonell Director, BTEC

About BTEC .......................................................3

Curriculum and enrollment ............................4

Facilities and equipment ................................7

Outreach to students and industry ..............8

Economic development activities ..............12

Finances ...........................................................13

Faculty and staff .............................................14

Advisory board ................................................15

Greetings from the director

Contents

2010 Annual Report | 3

The Golden LEAF Biomanufacturing Training and Education Center (BTEC) is a unique, cross-disciplinary instructional center that provides educational and training opportunities to develop skilled professionals for the biomanufacturing industry. It also provides bioproces develop-ment and analytical services to a wide range of customers from academia and industry.

Founded to help establish, attract and expand biomanufacturing in North Carolina and thus drive innovation and job creation, BTEC is located on North Carolina State University’s Centennial Campus in Raleigh. It operates under the auspices of the university’s College of Engineering (COE). The 82,500-gross-square-foot center, the largest of its kind in the U.S. and the world, features more than $12.5 million of industry-standard equip-ment and a simulated cGMP* pilot plant facility capable of producing biopharmaceutical products and packaging them in a sterile environment. Undergraduates, graduate students, and working professionals come to BTEC for hands-on learning with the latest biomanufacturing technologies.

* current Good Manufacturing Practice

BTEC partnershipsBTEC is member of NCBioImpact, a statewide public/private consortium whose purpose is to recruit, train, and retain workers for the state’s biomanufacturing industry. Other members include the North Carolina Community College System BioNetwork, the Biomanufacturing Research Institute and Technology Enterprise (BRITE) at North Carolina Central Univer-sity, the North Carolina Biotechnology Center (NCBC), the North Carolina Biosciences Organization (NCBIO), and the Golden LEAF Foundation, which provided almost $39 million to design and construct the BTEC facility. In addition to funding provided by Golden LEAF, NCBioImpact projects have received support from industry partners, which have provided services, equipment and monetary donations. The initiative receives operating funds from the state’s General Assembly.

BTEC also partners with schools and colleges within NC State to achieve its mission. These include the COE Department of Biomedical Engineering and Department of Chemical and Biomolecular Engineering, the College of Agriculture and Life Sciences (CALS) Depart-ment of Food, Bioprocessing and Nutrition Sciences and Department of Microbiology; and the College of Management Jenkins Graduate School of Management.

Strategic initiativesSeven strategic initiatives established by BTEC leadership guide both BTEC’s present activities and plans for the future.

Biomanufacturing

typically refers to

the production of

biopharmaceuticals,

that is, medical drugs

produced by biotech-

nology. Biotechnology

uses living organisms

or their components,

such as cells, tissue

and plasma.

About BTEC

Educate NC State undergraduate and graduate students in various aspects of biomanufacturing, including cell growth and expression in bioreactors, recovery, purification, analysis, and characterization.

Enhance the skills of biomanufacturing industry employees and professionals from other industries wishing to enter biomanufacturing.

Sponsor courses and events that will draw national and international subject matter experts to BTEC to educate external audiences nationally and internationally.

Maintain the BTEC facility as a state-of-the-art facility and increase capacity and functionality to draw additional students and development projects.

Collaborate with biotechnology, pharmaceutical, and supply companies to develop new technologies.

Educate K-12 students and teachers and college freshmen and sophomores on career opportunities in biomanufacturing and the opportunities provided by BTEC.

Provide leadership to the biotechnology and biomanufacturing community to help support and grow the industry, to ensure that BTEC programs are on the leading edge of processing technology, and to maintain support for BTEC from the state.

1

2

3

4

5

6

7


Curriculum and enrollment

Undergraduate and graduate programs

1Strategic initiatives

Since its inception, BTEC has developed and offered the following degree and certificate programs:

• An undergraduate biomanufacturing minor

• An undergraduate certificate in biomanufacturing, and

• A post-baccalaureate certificate in biomanufacturing

Now added to this list are the first graduate degrees in biomanufacturing in the U.S. Funded by a National Science Foundation award of $699,998 over three years, BTEC has created a Professional Science Masters (PSM) program in Biomanufacturing. Two Professional Science Master’s degrees provide advanced training in both life science and business. A Master of Biomanufacturing (non-thesis) and a Master of Science in Biomanufacturing (thesis option) are offered; both degrees are designated BIOM. Taught by faculty from the Colleges of Engineering, Agriculture and Life Sciences, and Management, the BIOM curriculum is an integrated multi-disciplinary program and includes hands-on advanced laboratory courses, regulatory compliance courses, and bioscience-focused MBA courses. Students in the program engage in industry case studies, participate in an internship, and complete a research experience. Final approval to award the degrees is expected during the 2010-2011 academic year.

To help establish the master’s program, a portion of the NSF funding is underwriting tuition and fees and allowing stipends to be paid to two cohorts of five students over the first three years. Tuition, fees and annual stipends of $15,000 are provided for five students in year one, 10 students in year two, and five students in year three. The first students in this new program began classes in August 2010. The application deadline for fall 2011 is February 1.

In addition to the PSM program, a graduate minor and two certificates are now in the planning stages. To facilitate the development of BTEC’s burgeoning graduate program, 12 BTEC courses originally offered as 400-level courses were approved to be offered for graduate credit. Students may now register for either a 400- or 500-level section of these courses.

BTEC courses continue to be an integral part of two undergraduate degree options: the Bachelor of Science in Chemical Engineering – Biomanufacturing Sciences Concentration, which is offered by the College of

Engineering, and the Bachelor of Science in Bioprocessing Science, which is offered by the College of Agriculture and Life Sciences. These degree options rely on BTEC courses to provide critical hands-on experience in biomanufacturing.

Enrollment and graduation figuresThe table below summarizes enrollment in undergraduate and graduate courses during 2009-2010.

Enrollment continues to increase toward the target of at least 250 undergraduate and graduate students enrolled in BTEC courses each semester. The graph below shows the growth in total course enrollments since classes began in the facility.

Other numbers to note:

• 23 students graduated with a biomanufacturing minor in 2009-2010. Their number, an increase of more than 100% over the previous academic year, was split almost evenly between the College of Engineering (all Chemical Engineering majors) and the College of Agriculture and Life Sciences, with one graduate from the College of Physical and Mathematical Sciences.

• 3 post-baccalaureate studies (PBS) students received the first post-baccalaureate certificate in biomanufacturing during the 2009-2010 academic year.

Level

Fall 2009 Spring 2010

No. of courses

Enroll-ment

No. of courses

Enroll-ment

Undergraduate 12 195 14 201

Graduate 4 16 8 25

Total 16 211 22 226

2 3

2009-2010 Course enrollment

BTEC course enrollments

0

50

100

150

200

250

Spring 2010

Fall 2009

Spring 2009

Fall 2008

Spring 2008

Fall 2007

48

106136

215 211 226


Professional development programsDuring 2009-2010, BTEC provided customized training courses to local companies; expanded offerings of open-enrollment professional development courses; and renewed its contract to provide a blended online/on-site training program to the FDA. In addition, vendors have continued to use BTEC facilities and equipment to offer courses to industry personnel; through August 2010, four different firms had offered seven different courses.

Intended primarily for working professionals, BTEC’s professional development courses do not earn academic credit but often receive continuing education units (CEUs).

Custom coursesThrough its customized courses, BTEC provided training to 59 industry professionals from local, national and global companies. Courses offered included:

• Biomanufacturing Boot Camp

• Hands-on Biomanufacturing

• Hands-on Automated Bioprocessing, and

• Cell Culture and Downstream Bioprocessing

BTEC also designed and began teaching a three-course series—on cell culture, downstream bioprocessing, and single-use disposables —that is offered to engineers who work for a large biomanufacturing company at various U.S. manufacturing sites.

Open-enrollment professional development coursesBTEC continues to collaborate with industry partners to design and develop learning experiences that enhance the knowledge and skills of biotech-nology and biomanufacturing professionals. The 2010 slate of open-enrollment professional develop-ment courses was expanded to eight, some of which were offered multiple times. Combined enroll-ment through July for these courses was 42, which included 9 students from BRITE, the Biomanufac-turing Research Institute and Technology Enter-prise at NC Central University.

In addition to these courses, a short course on Navigating the European Regulatory System was presented July 19-21 by Dr. Pierre Leveau, head of the Quality, Safety & Environmental Unit at the European Directorate for the Quality of Medicines and HealthCare (EDQM) in Stras-bourg, France, and Dr. Decebal Bora, currently the director of regulatory affairs at ActoGeniX in Ghent, Belgium. This course is the first offered as part of a collaboration between BTEC and the University of Strasbourg. The agreement between the two institutions calls for the development of a unique set of training opportunities for the pharmaceutical/biopharmaceutical industry, including shared certificate programs and an exchange program for students, interns and faculty. Nine participants attended this course, including two students from BRITE.

FDA training contractIn September 2009, the FDA exercised the second of four possible option years in its training contract with BTEC, and in February 2010, the second cohort of FDA pharmaceutical inspec-tors and field personnel completed the training program. The third FDA cohort has begun, and trainees completed the second course in the series in August 2010. The four courses that comprise the program are Upstream Biopro-cessing, Downstream Bioprocessing, Quality Control/Analytical, and Aseptic Processing.

During the summer of 2010, BTEC staff assisted with three Biomanu-facturing Boot Camp courses presented by BioNetwork’s Capstone Center, which is located on the BTEC premises. The week-long courses provided training to 21 participants from seven different community colleges across the state. Students either were completing the second year of an associate’s degree in biotechnology or had recently graduated. The boot camp provided a hands-on cGMP experi-ence that included a large-scale fermentation process, key operations in downstream processing, and clean room opera-tions. Student feedback was very positive, particularly regarding the hands-on activities with industry-standard equipment. Bruce Kaylos, program manager of the NCBIO Biotech Manufac-turers Forum, lauded the project, saying, “I believe that with this new program we have crossed a new threshold in job-ready training for the biotechnology workforce.”

BTEC assists BioNetwork Capstone Center with boot camp for NC community college students


BTEC has become an increasingly popular venue for academic and industry conferences, meetings and lectures. BTEC sponsored several seminars during the year and continues to co-sponsor the David F. Ollis Lecture Series with the Department of Chemical and Biomolecular Engineering. In collaboration with ABB, Inc. and the NCCCS BioNetwork Validation Academy,

BTEC also participated in the Second Annual Excitement Series, held on October 8, 2009, to intro-duce students and industry professionals to Process Analytical Technology (PAT). In addition, BTEC hosted a number of other events and meetings. A few of the events that took place during the past year are highlighted below:

• The Second Annual North Carolina Biotech-nology Center Bioprocessing and Process Development Symposium was hosted by BTEC September 24, 2009, and 125 participants attended. Guest speakers included Professor David C. James, Department of Chemical Engineering, University of Sheffield, Sheffield, UK; Professor Susan Sharfstein, Department of Chemical and Biomolecular Engineering and Biology, Rensselaer Polytechnic Insti-tute, Troy, New York; Kelly R. Wiltberger, Biogen-Idec, Research Triangle Park, North Carolina; Sigma Mostafa, Diosynth Biotechnology, Research Triangle Park.

• The 2009 Biofilm Conference was held at BTEC on November 10. Guest speakers included representatives from NC State, industry, and the FDA. Workshop presenters included BTEC’s Gary Gilleskie,

Associate Director, Operations, and Nat Hentz, Assistant Director, Analytical Lab.

• Thomas W. Peterson, Ph.D., head of the Engineering Directorate, National Science Foundation, presented a seminar entitled Engineering Our Future: The Role of the National Science Foundation at BTEC on November 19, 2009.

• The Southeast chapter of the Parenteral Drug Association held its spring conference at BTEC on April 13, 2010. The theme of the meeting was Emerging Regulatory and Compliance Topics.

• The College of Engineering Biotextiles, Bioma-terials and Biomanufacturing Seminar was held at BTEC April 26, 2010. Director Ruben Carbonell moderated oral presentations and an industry roundtable, while Professor Michael C. Flickinger presented a talk and poster on What is Biomanufacturing for industry and academic participants.

• The Third Annual David F. Ollis Lecture in Biochemical Engineering, Body-On-A-Chip: Using Biochemical Engineering Ideas For In Vitro Evaluation of Drugs was presented on May 3, 2010, by Professor Michael L. Schuler, James and Marsh McCormick Chair, Depart-ment of Biomedical Engineering, School of Chemical and Biomolecular Engineering, Cornell University, Ithaca, New York.

Lectures and seminars


Additional space leased BTEC is one of the first tenants in the new Keystone Science Center on Centennial Campus. The 5,000 square feet that BTEC has leased has been built to include an administrative area, a utilities area, and spaces for both a bench-scale lab and a pilot-scale facility.

When equipped and furnished, these new spaces will allow BTEC to accommodate more projects under our bioprocessing services initiative.

New equipmentThe equipment listed below was purchased in 2009-2010 to increase the capacity of undergraduate, graduate, and short courses and to increase BTEC’s capabilities for teaching, process development projects, and industry use.

Additional equipment purchases planned for 2010-2011 will add new capabilities and continue to increase capacity for academic and professional development courses.

Facilities and equipment

Lab Equipment Cost

LS Recovery & Purification Chromatography Skid $142,000

LS Recovery & Purification Chromatography Column $130,000

LS Fermentation Bioreactor Autosampler $67,000

Animal Cell Culture Rocker Bioreactor $46,000

IS Recovery Homogenizer $25,000

Small Scale Autoclave $84,000

Small Scale MALS/DLS $150,000

Small Scale Asymmetric Field Flow Fractionator $100,000

Analytical UPLC $89,000

Analytical Circular Dichroism/ Fluorescence Spectrometer

$97,000

Equipment purchased 2009-2010

4Strategic initiative

BTEC has leased 5,000 square feet in the new Keystone Science Center, which held its grand opening July 20.

At BTEC, students learning about biomanufacturing get hands-on training with industry-standard equipment in state-of-the-art facili-ties. The 82,500-gross-square-foot building features laboratories with bench-, intermediate- and pilot-scale bioprocessing equipment. The largest laboratory area simulates a cGMP pilot plant.

Labs were specifically designed to provide education in the following areas: bioreactor preparation; fermentation and cell culture processing; upstream disposables technologies; cell harvest and protein recovery; protein purifica-tion; equipment cleaning, steaming, and sanitization; product character-ization; tissue culture, and bionano-technology.

The BTEC facility boasts the following features:

• 9,000 GSF of high-tech class-rooms

• 63,000+ GSF of lab training space

• Bioreactors and control systems, including two 300L bioreactors, seven 30L bioreactors, and four single-use bioreactor systems

• Automation with next-generation distributed control architecture

• State-of-the-art analytical instrumentation

• Downstream recovery and purifi-cation equipment

• Aseptic processing capabilities

The BTEC experience


BTEC continues to engage in a variety of service and outreach activities to fulfill its commitments to students and industry.

Outreach to university studentsOutreach to and support of NC State students takes a variety of forms, ranging from providing infor-mation about BTEC programs at campus career fairs and advising student groups to offering scholar-ships for those working toward a biomanufacturing-related degree.

ScholarshipsContinuing a program begun in 2009, six biotechnology companies have each awarded two scholar-ships for NC State undergraduates interested in pursuing a career in bioprocessing and/or biomanu-facturing. Most scholarships provide $2,750 for tuition and fees annually until recipients complete the Biomanufacturing minor. One provides $5,000 annually, and some also offer internship opportunities. Scholarship sponsors and recipients for 2009-2010 are shown in the table below.

Outreach to students and industry

Scholarship provider Recipients pursuing a B.S. in Bioprocessing Sciences (CALS)

Recipients pursuing a B.S. in Chemical Engineering (COE)

Biogen Idec Rachel Geiger Tyler McCaw

Diosynth Biotechnology Nick Butterbaugh Garrett Pengelly

Glaxo Smith Kline – James Crews Sindhu Sevala

KBI Biopharma Aaron Anders Dominic Brown

Merck – Kristy Layton Chris Hanson

Novo Nordisk – Andrew Mills William McDanel

5Strategic initiatives

6 7

Scholarship provided 2009-2010

Winnell Newman, manager of student programs at BTEC, speaks with students about biomanufacturing careers during a ‘BTEC in the Brickyard’ event.


Fellowships and internships

The Grand Challenges in Biomanufacturing graduate fellowship program provided funding for five graduate teaching assistants for BTEC courses during the 2009-2010 academic year. In addition to serving as teaching assistants, recipi-ents participate in faculty-initiated, bioprocess-focused research projects using BTEC facilities.

BTEC offered five internships during the summer of 2010 to undergraduates in the BTEC minor program. Two students worked in the analytical lab, one in downstream processing, one in cell culture engineering, and one on the 2L Biore-actor WebLab project (see sidebar).

Placement and outreach

In 2009-2010, BTEC was represented at the NC State career fairs listed below.

• College of Engineering Career Fair

• College of Agriculture and Life Sciences Career Expo

• College of Physical and Mathematical Sciences Career Fair

• Minority Career Fair, hosted by the Union Activities Board, and

• Minors Fair, sponsored by the Office of Advising Support, Information and Services, part of the Division of Undergraduate Academic Programs

In addition, on March 26, BTEC held its own event, which was co-sponsored by the Carolina South Atlantic (CASA) chapter of the Interna-tional Society for Pharmaceutical Engineering (ISPE).

At this invitation-only event, nine companies in the RTP area and the FDA were repre-sented by 57 industry professionals. Of the 136 students invited to interview with one or more of these organizations, 56% garnered intern-ships, contract positions or permanent full-time positions. A team of volunteers from ISPE CASA, BTEC and various university departments staffed the event.

Other support efforts

The NC State student chapter of ISPE is one of the most active chapters in the world with more than 60 paying members, 60% of whom are pursuing degrees in chemical engineering. Other members are pursuing degrees in biochemistry, bioprocessing science, microbiology, biology and chemistry. The chapter hosted more than 22 events during the past year, including educa-tional, networking, and social responsibility activities, and many of these events took place at BTEC. The chapter’s 11-member student board is responsible for planning, communicating and conducting all activities. This organiza-tion provides student members and leaders with professional communication, networking and leadership experiences. BTEC’s Assistant Director, Student Coordination served as advisor to this organization for the past three years.

BTEC staff also work with units across the university to ensure that first- and second-year NC State students are aware of academic and career opportunities related to bioprocessing and biomanufacturing.

Students queue up to enter the March 26 BTEC career fair.

Funded by a sub award

from the American

Institute of Chemical

Engineers (AIChE) –

Society for Biological

Engineering (SBE),

the WebLab project

requires BTEC to design

and develop a pilot

educational program

enabling students at

other universities to

conduct experiments

by remotely controlling

one of BTEC’s 2L biore-

actors. The WebLab

pilot program will be

launched at four U.S.

universities in fall 2010.

WebLab project


BTEC continues to work with established outreach providers to deliver information about biomanu-facturing careers to middle school and high school students. As part of this initiative, BTEC mentors a fellow in the Kenan Fellows Program for Curriculum and Leadership Development, a program of NC State’s Kenan Institute for Engineering, Technology & Science. In June 2010, 18 middle and high school teachers from public schools across North Carolina attended a four-day workshop at BTEC entitled Biomanufacturing and Biotechnology for Middle Grades Teachers. A collaborative effort between BTEC, the North Carolina Biotechnology Center and Kenan Fellows Lori Stroud and Cinnamon Frame, the workshop familiarized middle school teachers with both general biotechnology topics and provided focused instruction and experiences in bioprocessing and biomanufacturing. The lessons shared with teachers, which they will use in their own classrooms, were developed as part of Stroud’s and Frame’s two-year Kenan Fellowships. The hands-on portions of the workshop were conducted in BTEC’s labs, and participants also toured Biogen Idec and participated in a question-and-answer session there. The workshop was funded by a grant from the North Carolina Biotechnology Center to disseminate the information about the projects Stroud and Frame completed as Kenan Fellows.

In addition to these outreach activities, BTEC provided tours of the facility and presented demonstrations for 12 groups of K-12 students during the past year.

K-12 outreach

As part of another outreach effort, in early 2010 the North Carolina Association for Biomed-ical Research (NCABR) used the BTEC facility and staff to produce several new videos about bioscience careers. Designed for middle and

high school teachers and students, the videos are now available online at: www.aboutbioscience.org/bc_title.html.

BTEC staff are featured in NCABR career videos.


BTEC staff provide facility tours at regularly scheduled intervals and accommodate special requests for visits by numerous educa-tional, commercial and governmental groups. A representative sampling of groups that toured BTEC during the past year appears on the right.

Collaboration with industryBTEC’s Bioprocess and Analytical Services initiative continued to grow during its second year of operation, working on 10 projects since July 2009. The initiative has provided needed services to companies, most of which have a significant presence in North Carolina, and to academic departments within the NC State community, including the Department of Poultry Science and groups within the College of Veterinary Medicine. Additionally, the initiative has benefited BTEC by providing an opportunity for its faculty and staff to stay abreast of the latest biomanufac-turing technology and methods. It has also generated real data and enhanced our processing methodologies for learning experiences.

Projects, which have utilized BTEC’s expertise and equipment in nearly all areas of the facility, have included the following:

• 30-L microbial fermentation runs for protein production;

• Scale-up of a mammalian cell culture process to 50-L;

• Evaluation of new disposable bioreactor prototypes;

• Scale-up of inclusion body recovery steps for a protein therapeutic;

• Analysis of a small molecule tumor suppressant in chicken plasma; and

• Screening for anti-viral properties among proprietary small molecules.

Dr. Gary Gilleskie gave a presentation about the initiative, The Business of Industry–Academic Collaboration: BTEC’s Experi-ence in Developing Collaborative Programs, at the 14th Recovery of Biological Products conference in August 2010 at Lake Tahoe, California. Dr. Ruben Carbonell also attended the conference. In addition, BTEC exhibited at the 17th Annual ISPE CASA Life Sciences Technology Show held March 23 in Raleigh and at the BioProcess International Conference & Exhibition in Raleigh October 12-16, 2009.

BTEC also takes an active role in the Bioprocessing and Process Development (BPD) Group, which is sponsored by the North Carolina Biotechnology Center (NCBC) and provides a forum for process development scientists and engineers to discuss industry developments. Dr. Michael Flickinger, Associate Director of Academic Programs, serves as a member of the of the BPD Steering Committee. He is also a member of the Industrial Advisory Board of the BioSciences Management Program of the Jenkins Graduate School of Management in the university’s College of Management.

Industry outreach

ABB

Alsace BioValley

Aveta Lifesciences USA

Beijing Institute of Technology

BioMerieux

Campbell University

Catawba (NC) County

China Agriculture University

Consulate General of France

Eldon James Corp.

Hanyang University (South Korea)

Institute for the Future Pall Life Science

Jejiang University (China) Korean Broadcasting System

Leadership Cary

Nagoya University (Japan)

National Academy of Engineering, Raleigh Grand Challenge Summit

National Science Foundation

North Carolina Area Health Education Centers (AHEC)

Novozymes

Prometic BioSciences

Quad County (Iowa) Corn Processors

Shanghai Newsummit BioPharma Group (China)

Shizuoka Prefectural Government (Japan)

Steris Corporation

Syngenta Biotechnology

Triangle Strategy Group

U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority

University of Surrey (UK)

Rensselaer Polytechnic Institute

Waters Corporation

2009-2010 BTEC tour attendees


In conjunction with industry representatives and economic development professionals from the univer-sity and state, BTEC supports the expansion of the biomanufacturing industry in North Carolina. One way in which it does this is by offering tours to firms interested in relocating to North Carolina or building facilities here. In addition, BTEC was a sponsor of the North Carolina Pavilion at the Bio International Convention, held in Chicago May 3-6.

Also in May, BTEC signed five memoranda of understanding with representatives of the Chinese Investment Promotion Agency during the China-North Carolina Bio Industry Seminar held at BTEC. The memoranda, which call for BTEC to provide GMP training, are with the Shanghai Urban Newsummit Biopharma, Hamner-Calvert Research-Zhangjiang Pharmaceutical Valley, Hamner- Zhangjiang Education Base, Hamner-Wuhan Optics Bio Valley, and Hamner-China Medical City. A proposal to provide this training is in development.

Economic development activities 7Strategic initiative

Director Ruben Carbonell speaks with members of the Chinese Investment Promotion Agency during their visit to BTEC in May.

Industry personnel and members of the academic community survey exhibits at the Fisher Scientific vendor show, held at BTEC Oct. 6, 2009.


For the second consecutive year, economic conditions during FY2009-2010 resulted in state-mandated university-wide budget cuts. Although the university and the College of Engineering absorbed some of the 10% cut, BTEC’s budget of not quite $6.4 million was reduced by 6.12% or $391,430, as indicated below.

However, much of this reduction was offset by the $282,200 BTEC received for services provided and new contracts and grants, as shown below.

Finances

Facility use

Testing services

Short courses

Educational tech fees

Facility use

Testing services

Short coursesShort courses $72,000Testing services

$53,800

Facility use $7,900

Educational tech fees $6,900

FDA - Option year 2 $71,600

AIChE - WebLab $57,000

NCBC grant for Biotech workshop $13,000

Total = $140,600 Total = $141,600

Personnel

Operating

Equipment

Reduction from the State of NCPersonnel $3,471,940 54.26%

State Budget Reduction $391,430

6.12%

Equipment $1,084,256 16.95%

Operating $1,450,619 22.67%

Distribution of 2009-2010 budget of $6,398,245

Services New Contracts/Grants

7 strategic initiatives

82,500 gsf in BTEC facility

12.5 million dollars worth of industry-standard equipment

23 graduates with biomanu-facturing minor in 2009-10

226 students in 22 courses in spring 2010

2 new graduate degrees in biomanufacturing

1 FDA training contract

8 professional development courses

10 bioprocess and analytical services projects

5,000 sq. ft. leased in new Keystone Science Center

BTEC by the numbers


BTEC leadership is provided by the following:

• Ruben Carbonell, Ph.D., Director

• Michael Flickinger, Ph.D., Associate Director, Academic Programs, and Director, Graduate Programs, and

• Gary Gilleskie, Ph.D., Associate Director, Operations

BTEC instructional personnel other than Drs. Flickinger and Gilleskie currently number seven, comprised of two teaching assistant professors, four senior scientists, and the assistant director of the analytical lab. Faculty from the College of Engineering and the College of Agriculture and Life Sciences also teach at BTEC, either in BTEC courses or courses offered by their home departments.

BTEC also employs personnel in the following areas: lab operations and maintenance staff (14 positions currently filled), student and industry support (3), instructional support (2), and administrative support (4).

ChangesIn July 2010, Rick Lawless resigned to return to industry. Rick served as Associate Director, Strategic Support, since BTEC’s founding.

Gary Gilleskie, formerly Associate Director of Process Development, is now Associate Director, Operations.

Ray Anover has joined BTEC as Assistant Director, Student Coordination and Industry Relations. He succeeds Marcelo Anderson, who took another position in May.

Two new senior scientists, Jennifer Ruiz and Baley Reeves, have joined BTEC to assist with upstream and downstream bioprocessing courses and projects, respectively. In addition, a new manager of professional development programs, Denis Jackson, and a new lab manager for the bench-scale labs, Michael Ray, have been hired. A new position for an additional maintenance engineer is planned, to replace BTEC’s former automation manager.

Awards and publicationsDr. Michael Flickinger was named a fellow of the American Chemical Society (ACS), Class of 2009. He is the first faculty member at NC State to be so named. The ACS Fellows Program recognizes members for their contributions to the chemical sciences and outstanding service to ACS. Dr. Flickinger is also the editor of the Encyclopedia of Industrial Biotechnology: Bioprocess, Biosepara-tion and Cell Technology, which was published by John Wiley & Sons in 2010.

Faculty and staff

COE Dean Louis Martin-Vega speaks with Rick Lawless at the latter’s farewell luncheon in July.


The BTEC Advisory Board meets three times each year to review and discuss course content, certification requirements, assessment, marketing, and facilities and equipment needs. Board members are listed below.

Name Title Organization

Esther Alegria, Ph.D. Vice President, Manufacturing, and General Manager

Biogen Idec

Marshall Bredwell, Ph.D. Director, Fermentation Novozymes

Tom Brna Operations Lead Merck

Lynn Dickey, Ph.D. Vice President, Research Biolex

Gerry Farrell, Ph.D. Senior Director, Upstream Development & Production

Diosynth-RTP, Inc.

Parker Flowers Director, Production Operations GlaxoSmithKline

Shawn Gallagher Sr. Director, Outsourcing Operations Eisai

Mike Heatherman COE Life Sciences and Specialty Chemicals

ABB, Inc.

Tommy Hielscher Director, Business Support Novo Nordisk

Bruce Kaylos Program Manager NCBIO

Bob Kelly, Ph.D. Director NCSU, BIT

Tim Kelly, Ph.D. Vice President, Biopharmaceutical Development

KBI BioPharma

James Kennamer Vice President, Manufacturing Talecris Biotherapeutics

Joe Lingle Head of Bulk Manufacturing, USFCC Novartis Vaccines & Diagnostics

Louis Martin-Vega, Ph.D. Dean NCSU, College of Engineering

Mahesh Prashad Head of Product Management Sartorius Stedim Biotech

Bill Scott Sr. Director, Engineering Pfizer

Philip Sheridan Industry Liaison North Carolina Community College System BioNetwork

Mark Sorrells Sr. Vice President Golden LEAF Foundation

Ken Tindall, Ph.D. Sr. Vice President, Science & Business Development

North Carolina Biotechnology Center

LiAn Yeh, Ph.D. Director North Carolina Central University, BRITE

Advisory board

BTEC Advisory Board 2009-2010

Golden LEAF Biomanufacturing Training & Education Center (BTEC)For the latest news about BTEC and information about upcoming events, visit us online at http://www.btec.ncsu.edu.

NC State University is dedicated to equality of opportunity. The University does not condone discrimination against students, employees, or applicants in any form. NC State commits itself to positive action to secure equal opportunity regardless of race, color, creed, national origin, religion, sex, age, or disability. In addition, NC State welcomes all persons without regard to sexual orientation.

1000 copies of this public document were printed at a cost of $1.42 per copy. This document was printed on paper with 10% recycled content.

Physical address850 Oval Drive Suite 195 Raleigh, NC 27606

Mailing addressNorth Carolina State University Campus Box 7928 Raleigh, NC 27695-7928

SM

This project received start-up support from the Golden LEAF Foundation.

Photo by Roger Winstead, NC State Univ. Communication Services

Opportunities for involvementTo learn more about BTEC, inquire about process development services, or discuss other interests you may have, please contact the appropriate individual from the list below:

To inquire about Contact

Academic programs and careers Career fairs Presentations or tours Scholarships Student placement

Ray Anover Assistant Director, Student Coordination and Industry Relations [email protected] (919) 513-8237

Assistance with analytical development Process development projects Routine analytical testing services Technology development

Dr. Gary Gilleskie Associate Director, Operations [email protected] (919) 515-0176

Economic development activities Facilities Industry outreach International activities Media inquiries Professional development courses

Dr. Ruben G. Carbonell Director [email protected] (919) 515-0177

All other inquiries (919) 513-2000

Phone: (919) 513-2000Fax: (919) 513-8235Email: [email protected]: www.btec.ncsu.eduGPS: 35.773014, -78.673868

Documents

btec_annual_report_2010