Course Detail

Many students are rightfully excited about a potential career in pharmaceutical biotechnology. Graduates in molecular biology, bioengineering, or many other fields can potentially take advantage of many exciting and lucrative careers opportunities in biotechnology development, manufacturing, commercial operations, quality assurance, regulatory affairs, business development, licensing, and investment fund management. To access such opportunities as quickly and successfully as possible, it is quite valuable to understand not only the basic principles of bioprocess engineering, but also have a more advanced background in a subspecialty or application area, such as fermentation, cell culture, and/or bioseparations. Furthermore, an advanced background in many areas, such as bioseparations, can be applied not only to a career in pharmaceutical biotechnology, but also many other areas of biotechnology, such as biofuels.

Bioprocess engineering, including bioseparations, is one the oldest and most successful professions. Success in large-scale recombinant protein manufacturing is a recent manifestation of a long and glorious history. Bioprocess engineering, including bioseparations, was and often still is a major skill set among those called brewer, winemaker, or in ancient times, wizard or sorcerer. The ability to successfully employ "the magic" of fermentation, as well as harvest and purify the vast range of resulting products through bioseparations, truly enriches ones life, no matter one's profession.

The primary goal of this course is to provide students with an advanced background in bioseparations science and engineering. Another goal is for students to gain substantial first-hand experience in the field, through a series of laboratory exercises.

Textbooks Required:  Bioseparations Science and Engineering, by Roger G. Harrison, Paul Todd, Scott R. Rudge, and Demetri Petrides, Oxford University Press, NY, 2003 Recommended:  Bioprocess Engineering Principles, by Pauline M. Doran, Elsevier Academic Press, 1995 (reprinted various years through at least 2004)

Introductory lectures and lab exercise
   Introduction to bioproducts and bioseparations 
   Case studies in bioseparations, from fermented beverages to recombinant proteins
   Fun in the fermented beverages lab
Analytical methods 
   Assay attributes: precision, accuracy, specificity, linearity, range, robustness
   Analysis of biological activity and purity
   Laboratory exercise in analystical methods
Unit operations in bioseparations, part 1
   Cell lysis and flocculation
   Filtration
   Sedimentation and centrifugation
   Laboratory exercise in flocculation, centrifugation and filtration
Unit operations in bioseparations, part 2
   Extraction
   Chromatography
   Precipitation
   Crystallization
   Drying
   Laboratory exercise in affinity chromatography and SDS-page analysis
Bioprocess Design
   Process flow diagrams and simulators
   Process economics
   Case studies: Upstream and downstream options for production and purification of monoclonal
   antibodies and antibody fragments
Bioprocessing plant tour
Final exam

Students will gain

• an understanding of the successful, interdisciplinary approach to bioprocessing and bioseparations, involving both biological sciences and engineering
• knowledge of classic case studies and historical developments in bioseparations
• an understanding of a broad range of analytical methods and the ability to determine assay attributes
• an understanding of the many unit operations employed in bioseparations, including first hand laboratory experience with the most common ones
• the ability to utilize a process flow diagram and determine process economics
• an understanding of the various upstream and downstream processing options for monoclonal antibodies and antibody fragments, the two categories of biopharmaceutical products undergoing the fastest growth.

Problem sets   25%                                        
Laboratory exercises   50%                                      
Final exam   25%