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Biomanufacturing Sciences Concentration in CBE Dr. Henry Lamb Associate Professor Department of Chemical & Biomolecular Engineering Biomanufacturing Training & Education Center 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. 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. 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) 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. 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) 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) Life Science Manufacturing in North Carolina Manufacturers of Pharmaceuticals, Diagnostics, Medical Devices, and Biologics Biomanufacturing North Carolina Biomanufacturing Companies • • • • • • • • Ajinomoto Archer Daniels Midland Argos Therapeutics Bayer Biogen Idec Biolex Corn Products Intl. Diosynth (Akzo Nobel) • • • • • • • Embrex Greer Laboratories KBI BioPharma Merck (Under construction) MWG Novozymes Wyeth Vaccines For more information, see the BTEC web site at: http://www.engr.ncsu.edu/btec/ or Contact me [email protected] or Dr. Michael Fickinger [email protected] or Dr. Hubert Winston [email protected] 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.