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EXPORT-ORIENTED MANAGEMENT - IMC Fachhochschule Krems

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iotech production facilities are presented in detail (support systems and utilities,<br />

production of cell culture media, bioreactors and product holding tanks and containers,<br />

cell separation and disruption systems, ultrafiltration equipment, process<br />

chromatography systems, freeze-drying).<br />

Teaching Methods<br />

Lecture<br />

Evaluation<br />

Final exam<br />

Genetic Engineering Laboratory under GLP<br />

Semester Hours per week Subject code ECTS<br />

Spring 2 GEN_L II 3<br />

Learning Outcomes / Course Objectives<br />

Upon completion of the course the students will<br />

� be able to apply good documentation practice<br />

� understand the application of GLP in a laboratory environment<br />

� use the applied lab techniques (Protein expression, purification,<br />

characterization; DNA purification, restriction, ligation, transformation,<br />

PCR)<br />

Prerequisites / Level<br />

Laboratory Skills, Genetic Engineering Laboratory, GLP/GMP seminar<br />

Course Description<br />

The experiments for the laboratory course ―Genetic Engineering Laboratory under GLP‖<br />

are discussed in the lecture ―GLP/GMP seminar‖. During that seminar a study plan and<br />

protocol sheets are prepared that are then used to document the work in the laboratory<br />

course.<br />

The Genetic Engineering Laboratory will take one week. During this week two<br />

experiments have to be performed:<br />

� Cloning and identification of recombinant clones<br />

� Protein expression and characterization<br />

Teaching Methods<br />

The Genetic Engineering Laboratory is based on the study plan which is prepared during<br />

the preceding GMP / GLP lectures. The students have to design protocol sheets to<br />

document their experimental observations as well as the raw data of their<br />

experiments. In order to meet the goals of the laboratory course the students will be<br />

assisted by the laboratory instructors, who will provide the students with practical tips<br />

and theoretical support. Since safety is a central question in the laboratory, the students<br />

will also have to identify potential hazards in the experimental setup and provide<br />

suggestions on how to minimize these risks during their practical work.<br />

FHR-5-0008_Vers.03_Rev.00_2012 535

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