Building a Biotechnology Laboratory with Good Laboratory Practice (GLP)
This is a laboratory course introducing students to some techniques commonly used in the biotechnology industry. The course will focus on the use of cell culture produced biological proteins in the assembly of an in vitro diagnostic (IVD) kit, such as an ELISA kit. The concepts of sterility, purification, assay development of a final product, creation of a Good Laboratory Practices (GLP) laboratory and the documentation of its operation & application will be discussed. There will be key emphases on GLP operation and designing all laboratory techniques to follow regulations from WHO and FDA. The course will require analysis of the assay design, production of assay data, and extensive writing on Standard Operating Procedures (SOP) to govern the laboratory; followed by internal and external auditing. The course will be taught by Dr. Sunny Tam and Dr. Masha Hareli. For permission to enroll into this course, please send email to email@example.com.