Biomanufacturing Sciences Concentration in CBE

1. Biomanufacturing Sciences Concentration in CBE Dr. Henry Lamb Associate Professor Department of Chemical & Biomolecular Engineering Biomanufacturing Training & Education Center

2. What is biomanufacturing? Biomanufacturing = production of value-added biomolecules (e.g., therapeutic proteins and vaccines) using cell culture and protein expression, recovery, and purification processes.

3. What is BTEC? The Biomanufacturing Training and Education Center (BTEC) is a pilot-scale biomanufacturing facility that will include support training and education classrooms, laboratories, building and process utilities. Students will gain bioprocessing experience using large-scale equipment, including bioreactors, downstream separation and purification processes, bioreactor control systems, and aseptic processing operations.

4. BTEC Educational Opportunties for CBE Students • Integrated Lecture/Lab Courses • BS CHE - Biomanufacturing Sciences Concentration • Minor in Biomanufacturing • BS/MS in Biopharmaceutical Engineering with Campbell University (to be proposed)

5. Learning Objectives (in addition to CBE core) • Overview of biomanufacturing and established biotechnology platforms. • Design, scale-up and control of bioreactors for microbial and cell culture operations with hands-on training at the bench and intermediate scales. • Downstream processing for recovery and purification of active biomolecules with hands-on training at the bench and intermediate scales. • Large-scale cGMP manufacturing campaign experience including batch records, SOPs, trouble-shooting, and regulatory compliance.

6. BTEC Courses • BEC 220 Introduction to Drug Development and Careers in Biomanufacturing (Dr. Michael Flickinger) • BEC 320 Fundamentals of Microbial Cell Culture (Dr. Jose Bruno-Barcena) • BEC 330 Fundamentals of Downstream Processing (Dr. John van Zanten) • BEC 420 Fundamentals of Microbial Cell Biotransformations (Dr. Jose Bruno-Barcena) • BIT 466 Animal Cell Culture (Dr. Paul Mozdziak)

7. BTEC Courses • BBS (BEC) 426 Industrial Microbiology & Biomanufacturing Laboratory (Dr. John Sheppard) • BEC 436 Downstream Processing of Biomaterials (Dr. Gary Gilleskie) • BIT 470 Advanced Animal Cell Culture-Bioreactor Culture (Dr. Paul Mozdziak) • BEC 480 Large-scale Fermentation (Mr. Rick Lawless) • BEC 485 Large-scale Recovery and Purification (Dr. Gary Gilleskie)

8. Manufacturers of Pharmaceuticals, Diagnostics, Medical Devices, and Biologics Biomanufacturing Life Science Manufacturing in North Carolina

9. Ajinomoto Archer Daniels Midland Argos Therapeutics Bayer Biogen Idec Biolex Corn Products Intl. Diosynth (Akzo Nobel) North Carolina Biomanufacturing Companies • Embrex • Greer Laboratories • KBI BioPharma • Merck (Under construction) • MWG • Novozymes • Wyeth Vaccines

10. For more information, see the BTEC web site at: http://www.engr.ncsu.edu/btec/ or Contact me lamb@ncsu.edu or Dr. Michael Fickinger mcflicki@ncsu.edu or Dr. Hubert Winston winston@ncsu.edu

11. Biotechnology or Biomanufacturing? The Minor in Biotechnology is designed to provide hands-on training for sophisticated, biotechnology-related laboratory techniques, to integrate molecular and genomics technologies with practical applications relevant to a student's chosen discipline, and to provide a conceptual framework for understanding risks and benefits of gene manipulations. The Minor in Biomanufacturing is intended to provide new graduates with the knowledge base and hands-on skills that will prepare them to quickly contribute to a cGMP biomanufacturing operation in significant ways and should reduce the time needed for on-the-job training in those operations.