The Masters in Biomanufacturing Newsletter
͞Where Biomanufacturing Meets Business͟ WƌŽĨĞƐƐŝŽŶĂů^ĐŝĞŶĐĞDĂƐƚĞƌ͛ƐWƌŽŐƌĂŵĂƚNorth Carolina State University
Biomanufacturing Training and Education Center (BTEC), Centennial Campus
Newsletter Vol. 1, Summer 2011 ʹ www.btec.ncsu.edu
Greetings from BTEC
This is the first of a tri-‐annual newsletter from North Carolina ^ƚĂƚĞ hŶŝǀĞƌƐŝƚǇ͛Ɛ (NCSU) Masters in Biomanufacturing (BIOM) program. This letter is sent to BTEC friends and colleagues in the field of biomanufacturing and biopharmaceuticals to keep them informed of updates, changes, and the latest happenings at this exceptional new program. The BIOM program is a rigorous, 44-‐hour Professional Science DĂƐƚĞƌ͛Ɛ(PSM) program focused on cross-‐training individuals in advanced scientific biomanufacturing theory as well as business knowledge in bioscience management. The BIOM program is based out of the 82,500 gross-‐square-‐foot, $50 million Biomanufacturing Training and Education Center (BTEC) located ŽŶ E^h͛Ɛ ĞŶƚĞŶŶŝĂů ĂŵƉƵƐ͘ BTEC, completed in 2007, is a simulated cGMP facility offering industry-‐scale, state-‐of-‐the-‐art equipment to train students and is the only training and education facility of its kind. The BIOM program was made possible due to a 3-‐year, $700,000 grant from the National Science Foundation. NCSU ǁĂƐŽŶĞŽĨϮϭƵŶŝǀĞƌƐŝƚŝĞƐĂǁĂƌĚĞĚĂ^ĐŝĞŶĐĞDĂƐƚĞƌ͛ƐWƌŽŐƌĂŵ grant out of more than 200 applicants from around the nation.
The Masters in Biomanufacturing Program
The BIOM PSM program is a new kind of degree that develops ƚŽŵŽƌƌŽǁ͛Ɛ ůĞĂĚĞƌƐ ďǇ ĐƌŽƐƐ-‐training individuals in not only their specific scientific discipline, but also in related areas of management. BIOM students will take a number of specialized courses including Global Regulatory Affairs, Biopharmaceutical Protein Characterization, Microbial Biotechnology, two semesters of Industry Practicum, professional skills training, a required industry internship, as well as their choice of focusing on either upstream or downstream processes. Either of these concentrations will require small, intermediate, and industry scale coursework. Students are required to take a minimum of 6 hours of MBA coursework if they are on a thesis-‐based MS track, or 9 hours of MBA coursework if they are completing the non-‐thesis MR track. In both cases all MBA classes are taken Ăƚ E^h͛Ɛ ŚŝŐŚůǇ ƌĞƐƉĞĐƚĞĚ :ĞŶŬŝŶƐ Graduate School of Management in the Poole College of Management. The BIOM program requires Project Management and a Strategic Management Foundations course. Applicants come from a wide variety of disciplines including Chemical Engineering, Biological and Bioprocess Engineering, Life Sciences, Pharmaceutical Sciences, directly from industry, and other undergraduate and graduate programs.
CompleƚĞĚŝŶϮϬϬϳŽŶE^h͛ƐĞŶƚĞŶŶŝĂůĂŵƉƵƐ͕dŝƐĂŶϴϮ͕ϱϬϬŐross-‐square-‐foot facility dedicated to biomanufacturing training and education. It is a simulated cGMP facility and the only one of its kind.
First Class now in Industry Internships The first class of BIOM students have officially completed their first year! Five of the six students have decided on the downstream processing track and all six students are currently working in their industry internships. Hope Metzler, Juan Ceuva, and Veronica Adams are at Biogen Idec in Research Triangle Park working in downstream processing. Sanaa Elouafiq is at Arbovax, a small start-‐up company, working on a vaccine for Dengue Fever. Renee Berry is working in granulation at Novozymes and Jane Winkleman continues to work at Eisai. The majority of the class and laboratory work for each of the students processing tracks were completed in their first year. MBA courses and biomanufacturing research will be the primary focus during the second year of the program. Multiple students have expressed interest in obtaining their Biosciences Management MBA at the Jenkins School of Management following their BIOM graduation and those students will therefore also be enrolled in prerequisite courses. dŚŝƐ &Ăůů͛Ɛ ϱϵϬ͗ /ŶĚƵƐƚƌǇ WƌĂcticum in Biomanufacturing course will focus on the production of Influenza Vaccine. The case study will require students to visit industry facilities and fully understand regulatory aspects in order to convert BTEC into a fully functioning vaccine facility.
First class of BIOM
students. Left to right: Sanaa Elouafiq, Renee Berry, Veronica Adams, Hope Metzler, Jane Winkleman, and Juan Cueva
Did You Know?
Update on UNCGA BIOM Approval
Since the inception of the NCSU Biomanufacturing undergraduate minor 3 years ago, BTEC students have 100% placement into industry or advanced education. NCSU was voted in Kiplinger Magazine as one of the top 15 best values in public education. Last year, BIOM students presented final projects from BEC 590: Industry Practicum at the North Carolina Biotechnology Center. Located in Research Triangle Park, it the oldest biotechnology center in the U.S. Less than 4 years after opening its doors BTEC exceeded its goal of 250 students per semester target enrollment ʹ an annual growth rate of 41 percent!
The BIOM program was originally expected to be approved by the University of North Carolina General Administration (UNCGA) by early Spring 2011. However, due to the retirement of President Erskine Bowles in early 2011 and the time spent searching for his subsequent replacement in Thomas W. Ross, the anticipated approval of the program has been pushed back. It currently stands that BIOM is the first program to be reviewed in the new fiscal year starting July 1, 2011. It is expected that BIOM will be fully accepted by Fall 2011. Until BIOM is officially approved, it is being conducted as a subset of the highly respected Chemical and Biomolecular Engineering department. Potential students interested in applying for the program should apply to the NCSU Graduate School under the Chemical EngineeringʹMR program.
>ŽŽŬŝŶŐƚŽƚŚĞ&ƵƚƵƌĞ͙ The BIOM program will grow to a minimum of 12 students per year within the next few years. BTEC faculty understand that many of our future students will come from an industry setting and will likely be enrolled as part time students.
In order to better accommodate working professionals, BTEC is already in the process of moving as many classes as possible to outside-‐of-‐ work hours. This coming Fall, two courses will be offered in the evening and one class will be offered online.
Students learning the Column Chromatography techniques in BTEC Purification Suite
Graduate Minor Approved Although the BIOM program is still awaiting final approval from the UNCGA, the Graduate Minor in Biomanufacturing has been officially approved. ͞This is a tremendous step forward for the graduate program as a whole and now allows students from other programs to gain valuable knowledge and hands-‐on experience at BTEC͟ƐĂǇƐŚƌŝƐ^ŵŝƚŚ͕ Program Coordinator for the BIOM program. For both Masters and Ph.D. Candidates, the graduate minor will require 2 credit hours of biomanufacturing research. The remaining credit hours are elective classes to be chosen by the student. Although not a requirement, we recommend students complete a FDA Regulatory Compliance course and an upstream or a downstream track. Like the BIOM program, a complete track includes small, intermediate, industry-‐ scale process development and cGMP operations courses.
Keeping up with Industry
BTEC is dedicated to keeping up with the latest trends in biomanufacturing. In order to make sure students are receiving the most up-‐to-‐date knowledge possible, BTEC keeps close ties with industry personnel by holding frequent meetings with the BTEC Advisory Board. The companies represented in the Advisory Board include:
Graduate students planning to obtain the Graduate Minor in Biomanufacturing would include individuals from Chemical Engineering, Microbial Biotechnology, Microbiology, Food Science and Physiology. The minimum credit hours for Masters students is 10, while the minimum required credit hours for Ph.D. students is 12.
More information on BIOM, contact: Chris Smith, Program Coordinator Email:Chris_Smith4@ncsu.edu Phone: (919) 513-‐2195