Basic Laboratory Methods in a Regulated Environment

Biotechnology transforms knowledge that emerges from life science research into technology, the creation of products of value to people. Beginning  biotechnology students therefore need to develop a strong foundation in laboratory science that is integrated with an understanding of product quality. This course provides students with a foundation in basic concepts and techniques necessary to work as effective professionals in a biotechnology laboratory or small scale production facility. The course emphasizes metrology (the study of measurements), solution preparation, performing assays, and basic biological separation methods. These fundamental laboratory techniques are essential for student success in later molecular biology, cell culture, bioprocessing, analytical, and other specialized courses. Throughout the course the principles of product quality systems (e.g., Good Manufacturing/Laboratory Practices and ISO 9000) are integrated as students explore documentation, calibration, accuracy and precision, error reduction, trouble-shooting, verification and validation of assays, and other quality concepts. Integrating a "quality-mindset" into their laboratory work is important both for students who plan to work in a biotechnology company and for students who some day aspire to generate meaningful results in a research environment.

Submitted by Lisa Seidman and Jeanette Mowery

Submission date:  May, 2011


Open materials

Published Textbooks:

Additional materials*

  • Syllabus
  • Classroom Activities
  • Lectures - video
  • Lectures - Power point
  • Sample of class discussion - video
  • Instructors' notes for laboratory manual (part I)
  • Instructors' notes for laboratory manual (part II)
  • Instructors' notes for laboratory manual (part III)
  • Sample Final Exam


*Please note:  You must log in to the Bio-LInk site to access the additional materials.  


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