266017 Bringing Industry to Students: Btec's Design of Courses in Downstream Bioprocessing

Wednesday, October 31, 2012: 3:34 PM
329 (Convention Center )
Baley Reeves and Gary Gilleskie, Biomanufacturing Training and Education Center, North Carolina State University, Raleigh, NC

Among chemical engineers graduating from NCSU with a bachelor’s degree, 80% begin their careers in industry.  This fact compels educators to design courses that are industry relevant to ensure students get off to a successful start as they begin their careers.

The Biomanufacturing Training and Education Center (BTEC) at NC State University has developed a series of industry-relevant, hands-on courses in downstream bioprocessing.  These courses are designed to take students through the steps required to put a biopharmaceutical manufacturing process in place -  from process development through process transfer to execution of the manufacturing process.  Along the way, students are required to demonstrate knowledge of the principles underlying relevant unit operations and knowledge of basic engineering principles (such as mass balances, fluid dynamics, and mass transfer) in the context of these unit operations, just as they would in a traditional unit operations course.  The unit operations covered include centrifugation, homogenization, chromatography, and filtration.

Throughout the semester, students are tasked with designing, scaling up, and executing at manufacturing scale a process to recover and purify recombinant green fluorescent protein (GFP) produced in E. coli.  Students determine “ranges” for key process parameters for each unit operation in BTEC’s intermediate-scale development labs.  Students scale up operations to process in BTEC’s 300-L (bioreactor scale) “large-scale” labs.  Lastly, students execute the process they have designed under simulated cGMP conditions to mimic a biopharmaceutical production environment.  The laboratories house equipment that is commonly used in industry.  Throughout the courses, concepts are presented in light of regulatory requirements that apply to biopharmaceutical manufacture.  These include ICH Q8(R2), Guidance for Industry: Pharmaceutical Development and 21 CFR Parts 210 & 211, Current Good Manufacturing Practice for the Manufacture, Processing, Packing, or Holding of Drugs.

This presentation will provide details on the content of these courses, lessons learned, and results from follow-up surveys with students showing how well knowledge was transferred to the workplace.

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