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Education and Training
Course Descriptions
The education center will offer the following courses in 2007
Cleanroom/Aseptic Processing
Two-day lecture and hands-on laboratory experience introducing students to cleanroom operations and maintenance, aseptic processing, environmental monitoring, and product sterility. In the first class, students will learn the architectural layout of the cleanroom and its importance in the principles of aseptic processing and environmental monitoring. The lab portion will include gowning and personnel qualification, aseptic media preparation, environmental monitoring techniques, and autoclave sterilization qualification. In the second class, students will evaluate environmental monitoring data from the previous class and test a "product" for bacterial contamination.
Tissue Culture Basics
This three-day lecture and hands-on laboratory course introduces the student to tissue culture techniques. The course begins with media formulation specific to different cell types, and implications for downstream processing. Students will perform fundamental techniques such as cell counting, seeding and passaging, freezing down cells for storage, thawing, and testing for viability. Testing methods for contamination will also be covered, and students will perform assays for detecting endotoxin and mycoplasma. The basic principles of creating a cell bank will be covered and students will perform scale-up operations utilizing the WAVE bioreactor. Cell cultures will be monitored throughout the course and a master cell bank will be created at the end of the cell culture process. Quality control issues will also be discussed and practiced during the process including following SOPs, and maintaining Batch Records.
Purification/Chromatography Processes
This is an introduction to the downstream processes of Industrial Biotechnology. Protein harvesting methods will be covered, including methods of filtration and cell processing. Students will become familiar with purification techniques used in large scale processing such as ion exchange, hydrophobic interaction, affinity and size exclusion chromatography, and will learn how to choose appropriate resins for model proteins, and how to arrange a logical order of columns. Small scale columns with the different types of resins will be run, providing students experience reading chromatograms with respect to the different approaches and applications of the columns. Additionally, students will learn how to clean and store a column after use.
Quality Control
Students will be introduced to the principles, techniques and documentation behind standard quality control procedures used to release raw materials and final products. The laboratory will provide opportunities to perform and analyze typical QC assays that incorporate PCR, ELISA, Gel Electrophoresis and blotting, plus students will participate in environmental monitoring procedures.
cGMP's in Biomanufacturing
This course covers cGMP regulations, how they influence the manner in which biopharmaceuticals are produced, and how successful compliance and performance are achieved through inter-departmental communication. All aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff will be addressed, as well as systems in place for written procedures to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process.